Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Jul. 26, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | MNKD | |
Entity Registrant Name | MannKind Corporation | |
Entity Central Index Key | 0000899460 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth 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 | 274,995,037 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenues: | ||||
Total revenues | $ 72,386 | $ 48,611 | $ 138,649 | $ 89,237 |
Expenses: | ||||
Cost of goods sold | 5,605 | 5,224 | 9,424 | 10,754 |
Research and development | 11,816 | 6,453 | 21,829 | 12,058 |
Selling | 11,495 | 14,002 | 23,096 | 27,312 |
General and administrative | 12,617 | 11,947 | 23,345 | 22,489 |
(Gain) loss on foreign currency transaction | (529) | 251 | (1,928) | 1,205 |
Total expenses | 55,776 | 46,890 | 105,317 | 93,514 |
Income (loss) from operations | 16,610 | 1,721 | 33,332 | (4,277) |
Other income (expense): | ||||
Interest income, net | 3,177 | 1,547 | 6,611 | 2,849 |
Interest expense on financing liability | (2,444) | (2,449) | (4,891) | (4,873) |
Interest expense | (6,051) | (6,873) | (8,618) | (9,659) |
Interest expense on liability for sale of future royalties | (4,383) | (8,631) | ||
(Loss) gain on available-for-sale securities | (1,550) | 932 | (1,550) | 932 |
Loss on extinguishment of debt | (7,050) | (7,050) | ||
Other expense | (143) | (32) | ||
Total other expense | (18,301) | (6,986) | (24,129) | (10,783) |
Income (loss) before income tax expense | (1,691) | (5,265) | 9,203 | (15,060) |
Income tax expense | 323 | 587 | ||
Net income (loss) | $ (2,014) | $ (5,265) | $ 8,616 | $ (15,060) |
Net income (loss) per share - basic | $ (0.01) | $ (0.02) | $ 0.03 | $ (0.06) |
Weighted average shares used to compute net income (loss) per share - basic | 273,056 | 265,626 | 271,706 | 264,802 |
Net income (loss) per share - diluted | $ (0.01) | $ (0.02) | $ 0.03 | $ (0.06) |
Weighted average shares used to compute net income (loss) per share - diluted | 273,056 | 265,626 | 279,358 | 264,802 |
Commercial product sales | ||||
Revenues: | ||||
Total revenues | $ 20,780 | $ 18,345 | $ 39,544 | $ 35,907 |
Collaborations and services | ||||
Revenues: | ||||
Total revenues | 26,014 | 11,211 | 50,862 | 22,597 |
Expenses: | ||||
Cost of revenue | 14,772 | 9,013 | 29,551 | 19,696 |
Royalties | ||||
Revenues: | ||||
Total revenues | $ 25,592 | $ 19,055 | $ 48,243 | $ 30,733 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net income (loss) | $ (2,014) | $ (5,265) | $ 8,616 | $ (15,060) |
Other comprehensive income: | ||||
Unrealized gain on available-for-sale securities | 443 | 443 | ||
Comprehensive income (loss) | $ (2,014) | $ (4,822) | $ 8,616 | $ (14,617) |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 96,643 | $ 238,480 |
Short-term investments | 151,118 | 56,619 |
Accounts receivable, net | 23,346 | 14,901 |
Inventory | 24,753 | 28,545 |
Prepaid expenses and other current assets | 30,080 | 34,848 |
Total current assets | 325,940 | 373,393 |
Restricted cash | 732 | |
Long-term investments | 13,398 | 7,155 |
Property and equipment, net | 85,144 | 84,220 |
Goodwill | 1,931 | 1,931 |
Other intangible asset | 1,033 | 1,073 |
Other assets | 15,658 | 7,426 |
Total assets | 443,836 | 475,198 |
Current liabilities: | ||
Accounts payable | 9,556 | 9,580 |
Accrued expenses and other current liabilities | 40,952 | 42,036 |
Liability for sale of future royalties - current | 12,149 | 9,756 |
Financing liability - current | 9,935 | 9,809 |
Deferred revenue — current | 7,420 | 9,085 |
Recognized loss on purchase commitments — current | 3,859 | |
Midcap credit facility - current | 20,000 | |
Total current liabilities | 80,012 | 104,125 |
Senior convertible notes | 227,577 | 226,851 |
Liability for sale of future royalties - long term | 135,365 | 136,054 |
Financing liability - long term | 94,094 | 94,319 |
Deferred revenue — long term | 66,116 | 69,794 |
Recognized loss on purchase commitments — long term | 60,183 | 60,942 |
Operating lease liability | 3,272 | 3,925 |
Financing lease liability | 184 | |
Milestone liabilities | 2,813 | 3,452 |
Mann Group convertible note | 8,829 | |
Accrued interest - Mann Group convertible note | 56 | |
Midcap credit facility - long term | 13,019 | |
Total liabilities | 669,616 | 721,366 |
Commitments and contingencies (Note 14) | ||
Stockholders' deficit: | ||
Undesignated preferred stock, $0.01 par value -- 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2024 or December 31, 2023 | ||
Common stock, $0.01 par value -- 800,000,000 shares authorized; 274,467,247 and 270,034,495 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 2,740 | 2,700 |
Additional paid-in capital | 2,992,271 | 2,980,539 |
Accumulated deficit | (3,220,791) | (3,229,407) |
Total stockholders' deficit | (225,780) | (246,168) |
Total liabilities and stockholders' deficit | $ 443,836 | $ 475,198 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
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 | 800,000,000 |
Common stock, shares issued | 274,467,247 | 270,034,495 |
Common stock, shares outstanding | 274,467,247 | 270,034,495 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Deficit - USD ($) shares in Thousands, $ in Thousands | Total | Convertible Note Interest The Mann Group L L C | Convertible Note Principal and Interest The Mann Group L L C | Common Stock | Common Stock Convertible Note Interest The Mann Group L L C | Common Stock Convertible Note Principal and Interest The Mann Group L L C | Additional Paid-in Capital | Additional Paid-in Capital Convertible Note Interest The Mann Group L L C | Additional Paid-in Capital Convertible Note Principal and Interest The Mann Group L L C | Accumulated Other Comprehensive Income | Accumulated Deficit |
Beginning Balance at Dec. 31, 2022 | $ (250,538) | $ 2,638 | $ 2,964,293 | $ (3,217,469) | |||||||
Beginning Balance (in shares) at Dec. 31, 2022 | 263,793 | ||||||||||
Issuance of common stock associated with at-the-market offering | 1,199 | $ 3 | 1,196 | ||||||||
Issuance of common stock associated with at-the-market offering (in shares) | 269 | ||||||||||
Issuance costs associated with at-the- market offering | (24) | (24) | |||||||||
Net issuance of common stock associated with stock options and restricted stock units | 52 | $ 2 | 50 | ||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 206 | ||||||||||
Issuance of common stock pursuant to conversion notes | $ 55 | $ 55 | |||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 11 | ||||||||||
Stock-based compensation expense | 3,655 | 3,655 | |||||||||
Net Income (Loss) | (9,795) | (9,795) | |||||||||
Ending Balance at Mar. 31, 2023 | (255,396) | $ 2,643 | 2,969,225 | (3,227,264) | |||||||
Ending Balance (in shares) at Mar. 31, 2023 | 264,279 | ||||||||||
Beginning Balance at Dec. 31, 2022 | (250,538) | $ 2,638 | 2,964,293 | (3,217,469) | |||||||
Beginning Balance (in shares) at Dec. 31, 2022 | 263,793 | ||||||||||
Net Income (Loss) | (15,060) | ||||||||||
Ending Balance at Jun. 30, 2023 | (260,487) | $ 2,682 | 2,968,917 | $ 443 | (3,232,529) | ||||||
Ending Balance (in shares) at Jun. 30, 2023 | 268,235 | ||||||||||
Beginning Balance at Mar. 31, 2023 | (255,396) | $ 2,643 | 2,969,225 | (3,227,264) | |||||||
Beginning Balance (in shares) at Mar. 31, 2023 | 264,279 | ||||||||||
Issuance of common stock associated with at-the-market offering | 1,583 | $ 4 | 1,579 | ||||||||
Issuance of common stock associated with at-the-market offering (in shares) | 362 | ||||||||||
Issuance costs associated with at-the- market offering | (17) | (17) | |||||||||
Issuance of common stock from market price stock purchase plan | 152 | 152 | |||||||||
Issuance of common stock under Market Price Stock Purchase Plan (in shares) | 36 | ||||||||||
Net issuance of common stock associated with stock options and restricted stock units | (8,544) | $ 32 | (8,576) | ||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 3,279 | ||||||||||
Issuance of common stock pursuant to conversion notes | 54 | 54 | |||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 13 | ||||||||||
Stock-based compensation expense | 5,580 | 5,580 | |||||||||
Issuance of common stock under the employee stock purchase plan | 923 | $ 3 | 920 | ||||||||
Issuance of common stock under the employee stock purchase plan (in shares) | 266 | ||||||||||
Cumulative gain on available-for-sale securities | 443 | 443 | |||||||||
Net Income (Loss) | (5,265) | (5,265) | |||||||||
Ending Balance at Jun. 30, 2023 | (260,487) | $ 2,682 | 2,968,917 | $ 443 | (3,232,529) | ||||||
Ending Balance (in shares) at Jun. 30, 2023 | 268,235 | ||||||||||
Beginning Balance at Dec. 31, 2023 | (246,168) | $ 2,700 | 2,980,539 | (3,229,407) | |||||||
Beginning Balance (in shares) at Dec. 31, 2023 | 270,034 | ||||||||||
Issuance of common stock associated with at-the-market offering | 1,361 | 1,361 | |||||||||
Issuance of common stock associated with at-the-market offering (in shares) | 416 | ||||||||||
Net issuance of common stock associated with stock options and restricted stock units | 266 | $ 3 | 263 | ||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 337 | ||||||||||
Issuance of common stock pursuant to conversion notes | $ 56 | $ 56 | |||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 15 | ||||||||||
Stock-based compensation expense | 3,885 | 3,885 | |||||||||
Net Income (Loss) | 10,630 | 10,630 | |||||||||
Ending Balance at Mar. 31, 2024 | (229,970) | $ 2,703 | 2,986,104 | (3,218,777) | |||||||
Ending Balance (in shares) at Mar. 31, 2024 | 270,802 | ||||||||||
Beginning Balance at Dec. 31, 2023 | (246,168) | $ 2,700 | 2,980,539 | (3,229,407) | |||||||
Beginning Balance (in shares) at Dec. 31, 2023 | 270,034 | ||||||||||
Net Income (Loss) | 8,616 | ||||||||||
Ending Balance at Jun. 30, 2024 | (225,780) | $ 2,740 | 2,992,271 | (3,220,791) | |||||||
Ending Balance (in shares) at Jun. 30, 2024 | 274,467 | ||||||||||
Beginning Balance at Mar. 31, 2024 | (229,970) | $ 2,703 | 2,986,104 | (3,218,777) | |||||||
Beginning Balance (in shares) at Mar. 31, 2024 | 270,802 | ||||||||||
Net issuance of common stock associated with stock options and restricted stock units | (4,933) | $ 19 | (4,952) | ||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 1,855 | ||||||||||
Issuance of common stock pursuant to conversion notes | $ 3,750 | $ 15 | $ 3,735 | ||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 1,500 | ||||||||||
Stock-based compensation expense | 6,428 | 6,428 | |||||||||
Issuance of common stock under the employee stock purchase plan | 959 | $ 3 | 956 | ||||||||
Issuance of common stock under the employee stock purchase plan (in shares) | 310 | ||||||||||
Net Income (Loss) | (2,014) | (2,014) | |||||||||
Ending Balance at Jun. 30, 2024 | $ (225,780) | $ 2,740 | $ 2,992,271 | $ (3,220,791) | |||||||
Ending Balance (in shares) at Jun. 30, 2024 | 274,467 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ 8,616 | $ (15,060) |
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||
Stock-based compensation | 10,313 | 9,235 |
Interest on liability for sale of future royalties | 8,631 | |
Loss on extinguishment of debt | 7,050 | |
Depreciation and amortization | 3,092 | 2,276 |
Write-off of inventory | 1,618 | 3,359 |
Loss on available-for-sale securities | 1,550 | (932) |
Loss on estimated returns of acquired product | 1,444 | |
Amortization of debt discount and issuance costs | 916 | 941 |
Amortization of right-of-use assets | 647 | 657 |
Other, net | 49 | (152) |
Sold portion of royalty revenue | (4,824) | |
Net accretion of investments | (2,109) | (77) |
(Gain) loss on foreign currency transaction | (1,928) | 1,205 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (8,890) | (10,988) |
Inventory | 2,174 | (6,877) |
Prepaid expenses and other current assets | (5,294) | (5,231) |
Other assets | (2,209) | (20) |
Accounts payable | (24) | 6,075 |
Accrued expenses and other current liabilities | (1,763) | 351 |
Deferred revenue | (5,343) | 24,320 |
Recognized loss on purchase commitments | (2,690) | (4,286) |
Operating lease liabilities | (546) | (1,153) |
Net cash provided by operating activities | 10,536 | 3,752 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of held-to-maturity debt securities | (187,447) | (26,447) |
Proceeds from held-to-maturity debt securities | 88,814 | 69,083 |
Purchase of property and equipment | (5,380) | (25,180) |
Proceeds from insurance claim | 396 | |
Net cash (used in) provided by investing activities | (103,617) | 17,456 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Principal and early extinguishment payments on MidCap credit facility | (36,617) | |
Principal and early extinguishment payments on Mann Group convertible note | (8,854) | |
Payments for taxes related to net issuance of common stock associated with restricted stock units and stock options | (4,667) | (8,492) |
Proceeds from market price stock purchase plan and employee stock purchase plan | 2,320 | 1,075 |
Principal payments on financing liability | (203) | (115) |
Principal payments on financing lease liability | (3) | |
Net cash used in financing activities | (48,024) | (4,791) |
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (141,105) | 16,417 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 238,480 | 69,767 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | 97,375 | 86,184 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | ||
Interest paid in cash | 8,324 | 4,259 |
Income taxes paid in cash | 1,725 | |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Amortization of liability for sale of future royalties | 1,589 | |
Non-cash construction in progress, property and equipment | 1,404 | 1,858 |
Addition of right-of-use-asset and financing lease liability | 226 | |
Right-of-use asset modification | 0 | 728 |
Goodwill adjustment for a net reduction in liabilities | 497 | |
The Mann Group L L C | ||
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||
Interest on Mann Group convertible note | 56 | 109 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Payments of Mann Group principal and interest through common stock issuances | $ 3,806 | 109 |
At The Market Issuance | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from at-the-market offering | 2,782 | |
Issuance costs associated with at-the-market offering | $ (41) |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (2,014) | $ 10,630 | $ (5,265) | $ (9,795) | $ 8,616 | $ (15,060) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | During the three months ended June 30, 2024, one of our executive officers adopted a written trading plan for the orderly disposition of the Company’s securities as set forth in the table below: Type of Trading Arrangement Name and Position Action Date Rule (1) Non-Rule (2) Total Shares of Common Stock to be Sold Expiration Date Stuart A. Tross , EVP Chief People and Workplace Officer Adoption May 31, 2024 X — 409,020 May 30, 2025 _________________________ (1) Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. (2) "Non-Rule 10b5-1 trading arrangement" as defined in Item 408(c) of Regulation S-K under the Exchange Act. |
Stuart A. Tross | |
Trading Arrangements, by Individual | |
Name | Stuart A. Tross |
Title | EVPChief People and Workplace Officer |
Rule 10b5-1 Arrangement Adopted | true |
Non-Rule 10b5-1 Arrangement Adopted | false |
Adoption Date | May 31, 2024 |
Expiration Date | May 30, 2025 |
Aggregate Available | 409,020 |
Description of Business and Sig
Description of Business and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Description of Business and Significant Accounting Policies | 1. Description of Business and Significant Accounting Policies The unaudited condensed consolidated financial statements of MannKind Corporation and its subsidiaries (“MannKind,” the “Company,” “we” or “us”), have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The information included in this quarterly report on Form 10-Q should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 27, 2024 (the “Annual Report”). In the opinion of management, all adjustments, consisting only of normal, recurring adjustments, considered necessary for a fair presentation of the results of these interim periods have been included. The results of operations for the three and six months ended June 30, 2024 may not be indicative of the results that may be expected for the full year. 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 condensed 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, 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 United Therapeutics' ("UT's") net revenue for the sale of Tyvaso DPI. Business — MannKind 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, UT, began commercializing Tyvaso DPI in June 2022 and is obligated to pay a 10 % royalty on net sales of the product, of which 9 % is allocated to the Company and 1 % to another party as detailed in Note 14 – Commitments and Contingencies . The Company also receives a margin on supplies of Tyvaso DPI that it manufactures for UT. Basis of Presentation — The condensed consolidated financial statements have been prepared in accordance with GAAP. Principles of Consolidation — The condensed 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 the prior period have been reclassified to conform with current period presentation. The Company has separated non-cash accretion income on investments from other, net, and presented it as net accretion of investments in the condensed consolidated statements of cash flows. The Company has also presented amortization of debt issuance costs on financing liability with depreciation and amortization and non-cash interest accretion on financing liability on a net basis in other, net. Additionally, the Company has combined accruals for the Danbury facility buildout with other in Note 7 – Accrued Expenses and Other Current Liabilities . 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 ("U.S."). 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's Customers obtain control of product upon delivery for wholesale distributors and generally at delivery for specialty pharmacies. The Company transfers control and 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. 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 are made when changes in the Company's assumptions result in revised estimates. 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 and Product Sales”). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were considered bundled services under the Manufacturing Services and Product Sales 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 9 – 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 9 – 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 long-term commercial supply agreement with UT (as amended, the "CSA") 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 UT License Agreement (as defined in Note 9 – Collaboration, Licensing and Other Arrangements ) 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 only collects 9 % of future royalties due to its sale in December 2023 of 1 % of future royalties as detailed in Note 14 – Commitments and Contingencies . The Company’s net revenue and cost of revenue and goods sold as shown on the condensed consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands): Three Months Six Months 2024 2023 2024 2023 Net revenue: Product revenue (1) $ 46,758 $ 29,278 $ 89,986 $ 58,004 Services (2) 36 278 420 500 Royalties (3) 25,592 19,055 48,243 30,733 Total net revenue $ 72,386 $ 48,611 $ 138,649 $ 89,237 _________________________ (1) Amounts represent the 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 9) for UT as well as arrangements with other collaboration partners. See Note 9 – Collaboration, Licensing and Other Arrangements . (3) Amounts represent royalties on UT’s net revenue from Tyvaso DPI sales. Three Months Six Months 2024 2023 2024 2023 Cost of goods sold and cost of revenue: Product revenue $ 20,377 $ 13,995 $ 38,628 $ 30,023 Services — 242 347 427 Total cost of goods sold and cost of revenue $ 20,377 $ 14,237 $ 38,975 $ 30,450 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 short-term and long-term deferred revenue on its condensed consolidated balance sheets 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, Cash Equivalents and Restricted Cash — 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 June 30, 2024 and December 31, 2023, cash equivalents were comprised of money market funds, U.S. Treasury securities, corporate bonds and commercial paper with original maturities less than 90 days from the date of purchase. The Company records restricted cash when cash and cash equivalents are restricted as to withdrawal or usage. Restricted cash under a letter of credit issued in connection with a facility lease assumed by the Company that will not be available for use in the Company’s operations within 12 months of the reporting date is presented in non-current assets. See Note 16 – Subsequent Events. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported on the consolidated balance sheets that sum to amounts reported on the condensed consolidated statements of cash flows (in thousands): June 30, 2024 December 31, 2023 Cash and cash equivalents $ 96,643 $ 238,480 Restricted cash 732 — Total cash, cash equivalents and restricted cash $ 97,375 $ 238,480 Held-to-Maturity Investments — The Company’s investments generally consist of commercial paper, corporate notes or bonds and U.S. Treasury securities. As of June 30, 2024 and December 31, 2023, 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 inve |
Investments
Investments | 6 Months Ended |
Jun. 30, 2024 | |
Schedule Of Investments [Abstract] | |
Investments | 2. 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 Company's investment in Thirona is comprised of two notes with aggregate face value of $ 8.0 million and stated interest rate of 10 %. The Thirona convertible notes are classified as available-for-sale securities and are included in other assets as of June 30, 2024 and prepaid expenses and other current assets as of December 31, 2023 in the condensed consolidated balance sheets. Available-for-sale investments are measured at fair value with realized gains and losses reported in other income (expense) in the condensed 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 scenario based method with a hypothetical yield of 33.0 % and 35.0 %, and volatility of 75.0 % and 90.0 % at June 30, 2024 and December 31, 2023, respectively. As of June 30, 2024 and December 31, 2023 , the fair value of the Company's investment in Thirona was $ 5.3 million and $ 6.9 million, respectively. For the three and six months ended June 30, 2024 , the Company recognized a loss of $ 1.6 million on its investment in Thirona as a result of modification of the Thirona convertible notes. For the three and six months ended June 30, 2023 , the Company recognized a gain of $ 0.9 million on its investment in Thirona as a result of the recovery of a temporary impairment and an unrealized holding gain of $ 0.4 million. For the three and six months ended June 30, 2024 , the Company recognized no interest income on investment and $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2023, respectively. 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 in the condensed consolidated statements of operations as interest income. For the three and six months ended June 30, 2024 , the Company recognized $ 3.2 million and $ 6.6 million, respectively, of interest income on investments, of which $ 2.0 million and $ 3.8 million, respectively, was net accretion on certain investments. For the three and six months ended June 30, 2023 , the Company recognized $ 1.4 million and $ 2.6 million, respectively, of interest income on investments, of which $ 0.4 million and $ 0.4 million, respectively, was net accretion on certain investments. No allowance for credit losses on held-to-maturity securities was required as of June 30, 2024 or December 31, 2023. The contractual maturities of the Company’s held-to-maturity investments are summarized below (in thousands): June 30, 2024 December 31, 2023 Amortized Aggregate Amortized Aggregate Due in one year or less (1) $ 231,331 $ 231,446 $ 115,263 $ 115,374 Due after one year through five years 13,398 13,478 7,155 7,197 Total $ 244,729 $ 244,924 $ 122,418 $ 122,571 ___________________________ (1) The investments due in one year or less include cash equivalents of $ 80.2 million as of June 30, 2024 and $ 58.6 million as of December 31, 2023 . The fair value of the cash equivalents, long-term and short-term investments are disclosed below (dollars in thousands). June 30, 2024 Investment Level Amortized Cost Gross Unrealized Holding Gross Unrealized Estimated Money market funds and other Level 1 $ 16,775 $ — $ — $ 16,775 Commercial bonds and paper Level 2 52,824 52 ( 69 ) 52,807 U.S. Treasury Securities Level 2 175,130 251 ( 39 ) 175,342 Total cash equivalents and investments 244,729 303 ( 108 ) 244,924 Less: cash equivalents ( 80,213 ) — — ( 80,213 ) Total Investments $ 164,516 $ 303 $ ( 108 ) $ 164,711 December 31, 2023 Investment Level Amortized Cost Gross Unrealized Holding Gross Unrealized Estimated Money market funds Level 1 $ 69,611 $ — $ — $ 69,611 Commercial bonds and paper Level 2 43,251 135 ( 38 ) 43,348 U.S. Treasury Securities Level 2 9,556 56 — 9,612 Total cash equivalents and investments 122,418 191 ( 38 ) 122,571 Less: cash equivalents ( 58,644 ) — — ( 58,644 ) Total Investments $ 63,774 $ 191 $ ( 38 ) $ 63,927 As of June 30, 2024 and December 31, 2023 , there was $ 0.8 million and $ 0.5 million, respectively, of accrued interest receivable on investments which is included in prepaid expense and other current assets in our condensed consolidated balance sheets. |
Accounts Receivable
Accounts Receivable | 6 Months Ended |
Jun. 30, 2024 | |
Receivables [Abstract] | |
Accounts Receivable | 3. Accounts Receivable Accounts receivable, net consists of the following (in thousands): June 30, 2024 December 31, 2023 Accounts receivable – commercial Accounts receivable, gross $ 22,270 $ 20,199 Wholesaler distribution fees and prompt pay discounts ( 3,750 ) ( 2,469 ) Reserve for returns ( 6,798 ) ( 6,215 ) Allowance for credit losses ( 157 ) ( 157 ) Total accounts receivable – commercial, net 11,565 11,358 Accounts receivable – collaborations and services 11,781 3,543 Total accounts receivable, net $ 23,346 $ 14,901 As of June 30, 2024 and December 31, 2023 , the allowance for credit losses and doubtful accounts for commercial accounts receivable of $ 0.2 million was related to accounts receivable for Zealand Pharma US, Inc. As of June 30, 2024 , the Company had three wholesale distributors representing approximately 84 % of commercial accounts receivable and 71 % and 70 % of gross sales during the three and six months ended June 30, 2024, respectively. As of June 30, 2024 and 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 June 30, 2024 and December 31, 2023 and approximately 100 % of gross revenue from collaborations and services for the three and six months ended June 30, 2024 . |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventories | 4. Inventories Inventories consist of the following (in thousands): June 30, 2024 December 31, 2023 Raw materials $ 5,984 $ 6,262 Work-in-process 9,784 13,646 Finished goods 8,985 8,637 Total inventory $ 24,753 $ 28,545 Work-in-process and finished goods as of June 30, 2024 and December 31, 2023 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 June 30, 2024 and December 31, 2023, 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 June 30, 2024 and December 31, 2023 . Inventory that did not meet acceptable standards or was forecasted to become obsolete due to expiration is reserved for inventory obsolescence in the condensed consolidated balance sheets and recorded in costs of goods sold in the condensed consolidated statements of operations. As a result of these assessments there were inventory write-offs of $ 0.6 million and $ 1.6 million for the three and six months ended June 30, 2024 , respectively, and $ 1.0 million and $ 3.4 million for the three and six months ended June 30, 2023 , respectively. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2024 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment consisted of the following (dollars in thousands): Estimated Useful Life (Years) June 30, 2024 December 31, 2023 Land — $ 875 $ 875 Buildings 39 - 40 17,389 17,389 Building improvements (1) 5 - 40 89,886 46,357 Machinery and equipment 3 - 15 64,983 60,410 Furniture, fixtures and office equipment 5 - 10 3,070 3,070 Computer equipment and software 3 8,677 8,658 Construction in progress (1) — 4,799 48,997 Total property and equipment 189,679 185,756 Less accumulated depreciation ( 104,535 ) ( 101,536 ) Total property and equipment, net $ 85,144 $ 84,220 ___________________________ (1) During the six months ended June 30, 2024 , the Company transferred $ 43.4 million from construction in progress to building improvements for assets placed in service related to the expansion of the Company's manufacturing facility. Depreciation expense related to property and equipment was as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 Depreciation Expense $ 1,711 $ 1,095 $ 3,052 $ 2,133 During each of the three and six months ended June 30, 2024 , the Company retired $ 0.1 million of manufacturing equipment as it was no longer in service. The net book value for the disposed assets was de minimis . There were no asset retirements during the three and six months ended June 30, 2023 . |
Goodwill and Other Intangible A
Goodwill and Other Intangible Asset | 6 Months Ended |
Jun. 30, 2024 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Goodwill and Other Intangible Asset | 6. 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 $ 1.9 million as of June 30, 2024 and December 31, 2023 as a result of the Company's acquisition of V-Go in May 2022. 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 1 – Description of Business and Significant Accounting Policies . Other Intangible Asset — Other intangible asset consisted of the following (dollars in thousands): Estimated June 30, 2024 December 31, 2023 Useful Cost Accumulated Net Book Value Cost Accumulated Net Book Value Developed technology 15 $ 1,200 $ ( 167 ) $ 1,033 $ 1,200 $ ( 127 ) $ 1,073 Amortization expense related to the other intangible asset was de minimis for the three and six months ended June 30, 2024 and 2023. 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 $ 0.6 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 1 – Description of Business and Significant Accounting Policies . |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities were comprised of the following (in thousands): June 30, 2024 December 31, 2023 Salary and related expenses $ 12,656 $ 19,506 Discounts and allowances for commercial product sales 10,965 9,541 Accrued interest (1) 6,165 2,153 Deferred lease liability 1,812 1,423 Current portion of milestone rights liability (2) 1,391 752 Returns reserve for acquired product (3) 1,290 601 Professional fees 656 979 State income tax liability 424 1,561 Other 5,593 5,520 Accrued expenses and other current liabilities $ 40,952 $ 42,036 _________________________ (1) As of June 30, 2024, accrued interest includes $ 4.2 million related to a milestone payment of $ 5.0 million to be paid in the third quarter of 2024. See Note 14 – Commitments and Contingencies under Milestone Rights . (2) As of June 30, 2024, the current portion of milestone rights liability includes $ 0.8 million to be paid in the third quarter of 2024 and $ 0.6 million reclassified from long-term to short-term milestone right liability. (3) See Note 14 – Commitments and Contingencies under Loss Contingencies — Returns Reserve for Acquired Product . |
Borrowings
Borrowings | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Borrowings | 8 . Borrowings Carrying amount of the Company's borrowings consisted of the following (in thousands): June 30, 2024 December 31, 2023 Senior convertible notes $ 227,577 $ 226,851 MidCap credit facility — 33,019 Mann Group convertible note — 8,829 Total debt – net carrying amount $ 227,577 $ 268,699 The following table provides a summary of the Company’s principal balance of debt and key terms: Amount Due Terms June 30, 2024 December 31, 2023 Annual Interest Maturity Date Conversion Price Senior convertible notes $ 230.0 million $ 230.0 million 2.50 % March 2026 $ 5.21 MidCap credit facility (1) $ — $ 33.3 million one-month 1 % floor) 6.25 %; 8.25 % August 2025 N/A Mann Group convertible note (2) $ — $ 8.8 million 2.50 % December 2025 $ 2.50 _________________________ (1) Repaid on April 1, 2024. (2) Repaid on April 2, 2024. The maturities of the Company’s borrowings as of June 30, 2024 are as follows (in thousands): Amounts Remainder of 2024 $ — 2025 — 2026 230,000 Total principal payments 230,000 Debt issuance costs ( 2,423 ) Total debt $ 227,577 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 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 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 June 30, 2024 and December 31, 2023 , the unamortized debt issuance cost was $ 2.4 million and $ 3.1 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. Tranche 1 and Tranche 2 accrued interest at an annual rate equal to the lesser of (i) 8.25 % and (ii) the one-month Secured Overnight Financing Rate ("SOFR") (subject to a one-month SOFR floor of 1.00 %) plus 6.25 %. Interest on each term loan advance was due and payable monthly in arrears. Principal on each term loan advance under Tranche 1 and Tranche 2 was payable in 24 equal monthly installments that began September 1, 2023 . During the three months ended March 31, 2024, the Company made $ 5.0 million in principal payments on the MidCap credit facility. On April 1, 2024, the Company exercised its option to prepay in full all outstanding indebtedness, consisting of $ 28.3 million in principal and $ 0.2 million in accrued interest, and terminated all commitments and obligations under the MidCap credit facility that would have matured on August 1, 2025 in exchange for a payment of $ 31.6 million, including an exit fee of $ 2.8 million which is 7.00 % of the initial Tranche 1 balance of $ 40.0 million, and a prepayment fee of $ 0.3 million which is 1.00 % of principal prepaid. Additionally, unamortized debt discount and capitalized prepayment fees totaling $ 0.2 million were written off, resulting in a loss on extinguishment of debt of $ 3.3 million recognized in the condensed consolidated statements of operations. In connection with the repayment of outstanding indebtedness by the Company, all liens, mortgages and security interests in any assets or property securing the obligations under the MidCap credit facility were automatically terminated and released and the Company was automatically released from all guarantees. Mann Group convertible note — In August 2019, the Company issued a $ 35.0 million note that was 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 accrued interest at the rate of 2.5 % per year on the principal amount, payable quarterly in arrears on the first day of each calendar quarter, with a maturity date of December 31, 2025 . The principal and any accrued and unpaid interest under the Mann Group convertible note was convertible, 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. Interest on the convertible note was 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 had the option to pay any such interest on any interest payment date, if certain conditions were met, in shares of the Company’s common stock at a price per share equal to the last reported sale price on the trading day immediately prior to the payment date. During the six months ended June 30, 2024 , Mann Group converted $ 0.1 million of interest into 15,285 shares of common stock. During the six months ended June 30, 2023 , Mann Group converted $ 0.1 million of interest into 23,683 shares of common stock. On April 2, 2024, the Company and Mann Group agreed to discharge and terminate the Mann Group convertible note. As of April 2, 2024, the outstanding principal balance of the Mann Group convertible note plus accrued interest was $ 8.9 million and was convertible at Mann Group’s option into 3,554,198 shares of common stock of the Company. The Company and Mann Group agreed to terminate all outstanding indebtedness, rights and obligations under the Mann Group convertible note in exchange for (i) the Company’s issuance to Mann Group of 1,500,000 shares of the Company’s common stock converted at the contractual rate of $ 2.50 per share and (ii) the Company’s payment to Mann Group of $ 8.9 million, which represented the market value of 2,054,198 shares of common stock of the Company on April 2, 2024 to settle the remaining principal and interest of $ 5.1 million, after the conversion noted in (i) above. Termination of the Mann Group convertible note resulted in a loss on extinguishment of debt of $ 3.7 million recognized in the condensed consolidated statements of operations. Amortization of the premium and accretion of debt issuance costs related to all borrowings were as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 Amortization of debt discount and prepayment fee $ — $ 108 $ 85 $ 214 Amortization of debt issuance cost 363 363 726 727 |
Collaboration, Licensing and Ot
Collaboration, Licensing and Other Arrangements | 6 Months Ended |
Jun. 30, 2024 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration, Licensing and Other Arrangements | 9. Collaboration, Licensing and Other Arrangements Revenue from collaborations and services were as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 UT CSA (1) $ 25,978 $ 10,933 $ 50,442 $ 22,097 UT License Agreement (2) — 242 347 427 Cipla License and Distribution Agreement 36 36 73 73 Total revenue from collaborations and services $ 26,014 $ 11,211 $ 50,862 $ 22,597 _________________________ (1) Amounts consist of revenue recognized for Manufacturing Services and Product Sales 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. 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): Three Months Six Months 2024 2023 2024 2023 UT Revenue UT CSA $ 25,978 $ 10,933 $ 50,442 $ 22,097 UT License Agreement — 242 347 427 Royalties – Collaboration (1) 25,592 19,055 48,243 30,733 Total revenue from UT $ 51,570 $ 30,230 $ 99,032 $ 53,257 _________________________ (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 condensed 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 the: (1) R&D Services and License, (2) Next-Gen R&D Services, and (3) 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 Product Sales 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 and Product Sales 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 and Product Sales 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. In February 2024, the Company began in-house kitting of certain Tyvaso DPI stock-keeping units. The Company's obligation to perform such in-house kitting is accounted for separately as it is distinct from Manufacturing Services and Product Sales and offered at a standalone selling price. Revenue for in-house kitting is recognized at a point in time as services are rendered. As of June 30, 2024 , deferred revenue from UT consisted of $ 72.3 million, of which $ 7.3 million was classified as current and $ 65.0 million was classified as long-term on the condensed consolidated balance sheet. 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 condensed consolidated balance sheet. The Company determined that the revenue recognition associated with the capital improvements should be combined with the Manufacturing Services and Product Sales 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 fibrotic pulmonary diseases. 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 condensed 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 whic h $ 1.0 million has been funded through June 30, 2024. 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 in 2023 or the first two quarters of 2024. 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. Cipla is currently seeking regulatory approval with the India authorities. 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 payment represents variable consideration for which the Company has not recognized any revenue because Cipla has not yet obtained all of the required marketing approvals. As of June 30, 2024 , the deferred revenue balance was $ 1.2 million, of which $ 0.1 million was classified as current and $ 1.1 million was classified as long term in the condensed consolidated balance sheets. 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 condensed consolidated balance sheets. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 10. 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 condensed 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): June 30, 2024 Fair Value Carrying Value Significant Financial liabilities: Senior convertible notes (1) $ 227.6 $ 258.9 Milestone rights (2) 3.9 10.6 Contingent milestone liability (3) 0.3 0.3 Financing liability (4) 104.0 106.6 Liability for sale of future royalties (5) 147.5 163.9 _________________________ (1) Fair value was determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 11.0 %, volatility of 53.0 % 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 $ 253.0 million and $ 265.0 million, respectively. (2) Fair value was determined by applying a Monte Carlo simul ation 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 4.3 %, dividend yield of 0.0 %, volatility of 50.0 %, period of 7.5 years and credit risk of 15.0 %. (3) Fair value was determined by 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 4.5 %, dividend yield of 0.0 %, volatility of 60.0 %, period of 13.5 years and credit risk of 15.0 %. (4) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 9.5 %. A change in yield of + or – 2 % would result in a fair value of $ 94.0 million and $ 122.1 million, respectively. (5) At June 30, 2024, fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 11.0 %. A change in yield of + or – 2 % would result in a fair value of $ 144.1 million and $ 188.3 million, respectively. At December 31, 2023, the carrying value approximated the fair value. December 31, 2023 Fair Value Carrying Value 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 11.0 %, 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 12.0 %. 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 13.0 % 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 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 3.9 %, dividend yield of 0.0 %, volatility of 50.0 %, period of 8 years and credit risk of 17.0 %. (5) Fair value was determined by 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 4.0 %, dividend yield of 0.0 %, volatility of 43.0 %, period of 15 years and credit risk of 17.0 %. (6) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 9.5 %. 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 a Monte-Carlo Simulation Method to simulate the Afrezza net sales under a neutral framework to estimate the potential payments and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. 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 14 – 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. Financing Liability — The Sale-Leaseback Transaction in November 2021 resulted in a financing liability. See Note 14 – Commitments and Contingencies . Liability for Sale of Future Royalties — The sale of a portion of our royalty rights in December 2023 resulted in a liability for sale of future royalties. See Note 14 – Commitments and Contingencies . |
Common and Preferred Stock
Common and Preferred Stock | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Common and Preferred Stock | 11. Common and Preferred Stock 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 June 30, 2024 and December 31, 2023, 274,467,247 and 270,034,495 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. There were no sales under the CF Sales Agreement during the six months ended June 30, 2024. During the six months ended June 30, 2023 , the Company sold 631,383 shares of common stock at a weighted average purchase price of $ 4.40 per share for gross proceeds of approximately $ 2.8 million pursuant to the CF Sales Agreement. During the six months ended June 30, 2024 , the Company received $ 1.4 million from the market price stock purchase plan ("MPSPP") for 416,099 shares of common stock. During the six months ended June 30, 2023, the Company received $ 0.2 million from the MPSPP for 36,004 shares. For shares of common stock issued pursuant to the Company's 2004 employee stock purchase plan ("ESPP"), see Note 13 – Stock-Based Compensation Expense. |
Earnings Per Common Share
Earnings Per Common Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Earnings Per Common Share | 12. Earnings per Common Share The following tables summarize the components of the basic and diluted EPS computations (in thousands, except per share amounts): Three Months Six Months 2024 2023 2024 2023 EPS — basic: Net income (loss) (numerator) $ ( 2,014 ) $ ( 5,265 ) $ 8,616 $ ( 15,060 ) Weighted average common shares (denominator) 273,056 265,626 271,706 264,802 Net income (loss) per share $ ( 0.01 ) $ ( 0.02 ) $ 0.03 $ ( 0.06 ) EPS — diluted: Net income (loss) — basic $ ( 2,014 ) $ ( 5,265 ) $ 8,616 $ ( 15,060 ) Weighted average common shares 273,056 265,626 271,706 264,802 Effect of dilutive securities — common shares issuable — — 7,652 — Adjusted weighted average common shares (denominator) 273,056 265,626 279,358 264,802 Net income (loss) per share $ ( 0.01 ) $ ( 0.02 ) $ 0.03 $ ( 0.06 ) For the six months ended June 30, 2024 , diluted net income per share excluded the weighted average effect of 7.8 million RSUs and Market RSUs, 1.9 million options and PNQs and 44.1 million common shares issuable upon conversion of our Senior convertible notes, as they were antidilutive. Common shares issuable represents incremental shares of common stock which consist of RSUs, stock options, warrants, and shares that could be issued upon conversion of the Senior convertible notes and the Mann Group convert ible notes. Potentially dilutive securities outstanding which were considered antidilutive due to the net losses incurred for the three months ended June 30, 2024 and three and six months ended June 30, 2023 are summarized as follows (in shares): June 30, 2024 2023 Senior convertible notes 44,120,463 44,120,463 RSUs and Market RSUs (1) 16,750,557 16,951,734 Common stock options and PNQs 7,920,453 8,688,625 Mann Group convertible notes — 3,370,000 Total shares 68,791,473 73,130,822 __________________________ (1) Market RSUs issued in 2021, 2022 and 2023 are included at the share delivery of 194 %, 178 % and 100 %, respectively, in accordance with a valuation assessment obtained as of June 30, 2024. |
Stock-Based Compensation Expens
Stock-Based Compensation Expense | 6 Months Ended |
Jun. 30, 2024 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation Expense | 13. Stock-Based Compensation Expense The Company granted the following awards (in shares): Three Months Ended Three Months Ended Six Months Ended 2024 2024 2024 Employee awards: RSUs 267,990 (1) 3,205,910 (2) 3,473,900 Market RSUs — 2,144,000 (3) 2,144,000 Non-employee director RSUs — 280,376 (4) 280,376 Total awards issued 267,990 5,630,286 5,898,276 _________________________ (1) RSUs had a weighted average grant date fair value of $ 3.28 per share, of which 211,895 RSUs had a vesting period of 33.3 % annually over the second , third , and fourth anniversary of the vesting determination date, 53,720 RSUs had a cliff vesting period of three years , and 2,375 RSUs had a vesting period of 25 % annually over four years . (2) RSUs had a weighted average grant date fair value of $ 4.45 per share, of which 3,033,680 RSUs had a vesting period of 25 % annually over four years , 145,980 RSUs had a vesting period of 33.3 % annually over the second , third , and fourth anniversary of the vesting determination date, and 26,250 RSUs had a cliff vesting period of two years . (3) Market RSUs had a grant date fair value of $ 10.30 per share and will vest on July 15, 202 7 . 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, 2024 until June 30, 2027 relative to the TSR of the Russell 3000 Pharmaceutical & Biotechnology Index over the same three-year period, as follows: less than 25th percentile= 0 % of target, 25th percentile= 50 % of target, 50th percentile= 100 % of target, 75th percentile= 200 % of target, 90th percentile or higher= 300 % maximum. Payout values will be interpolated between the percentile rankings above. (4) RSUs had a weighted average grant date fair value of $ 4.45 per share and vested immediately upon the grant date; however, the underlying shares of common stock will not be delivered until there is a separation of service such as resignation, retirement or death. As of June 30, 2024 , there was $ 28.2 million and $ 31.4 million of unrecognized stock-based compensation expense related to RSUs and Market RSUs, respectively, which is expected to be recognized over a weighted average period of approximately 2.84 and 2.22 years, respectively. Total stock-based compensation expense recognized in the condensed consolidated statements of operations as cost of goods sold, cost of revenue – collaborations and services, R&D and selling, general and administrative expense was as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 RSUs and options $ 6,248 $ 5,404 $ 9,947 $ 8,882 Employee stock purchase plan 180 176 366 353 Total $ 6,428 $ 5,580 $ 10,313 $ 9,235 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. There were approximately 2.6 million shares of common stock available for issuance under the ESPP as of June 30, 2024 . |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. 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 condensed 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. The Company does not anticipate the final disposition of any matters will have a material adverse effect on the results of operations, financial position, or cash flows of the Company. 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, $ 55.0 million of which remains payable to the Milestone Purchasers as of June 30, 2024. 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. As of June 30, 2024 and December 31, 2023, the remaining Milestone Rights liability balance was $ 3.9 million and consisted of $ 1.4 million and $ 0.8 million, respectively, of current liability, which was presented as accrued expenses and other current liabilities, and $ 2.5 million and $ 3.1 million, respectively, of long-term liability, which was presented as milestone liabilities in our condensed consolidated balance sheets. During the three months ended June 30, 2024 , an Afrezza sales milestone was achieved, resulting in a remeasurement amount of $ 4.2 million, which was recorded as interest expense and reflected in accrued expenses and other current liabilities in the condensed consolidated balance sheets at June 30, 2024. The value of the Milestone Rights liability was based on initial fair value estimates calculated using the income approach and is reduced by milestone achievement payments made. Loss Contingencies — Returns Reserve for Acquired Product — During the six months ended June 30, 2024, the Company reassessed its previously-determined estimate for product returns associated with sales of V-Go that pre-date the Company's acquisition of the product and recorded an additional $ 1.4 million, of which $ 1.3 million remains and is included in accrued expenses and other current liabilities in the condensed consolidated balance sheets as of June 30, 2024 . Losses on estimated returns of acquired product totaling $ 0.3 million and $ 1.4 million were recorded in general and administrative expenses in the condensed consolidated statements of operations for the three and six months ended June 30, 2024, respectively. Liability for Sale of Future Royalties — In December 2023, 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 UT License Agreement (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 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 UT License Agreement 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 condensed 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) are reported net of the Royalty Liability balance and amortized to interest expense in the condensed consolidated statements of operations over the life of the PSA using the effective interest method. Unamortized transaction costs totaled $ 4.3 million and $ 4.4 million at June 30, 2024 and December 31, 2023, respectively. The Company will continue to recognize the full 10 % of future royalty revenues in its condensed consolidated statements of operations, with the Sagard Royalty being non-cash revenue for the Company. As royalty payments are earned by and 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 condensed 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. 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 following table shows the activity within the Royalty Liability account during the six months ended June 30, 2024 as well as the effective interest rate (dollars in thousands): Balance, January 1, 2024 $ 145,810 Amortization of deferred transaction costs 114 Non-cash interest expense on liability for sale of future royalties 8,517 Royalty revenue earned by or payable to Sagard ( 6,927 ) Balance, June 30, 2024 $ 147,514 Effective interest rate 11.1 % — 11.5 % Sale-Leaseback Transaction — 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 the conditions contained in a purchase and sale agreement. 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 June 30, 2024, the related financing liability was $ 104.0 million, which was recognized in the condensed consolidated balance sheet and of which $ 94.1 million was long-term and $ 9.9 million was current. As of December 31, 2023, the related financing liability was $ 104.1 million, of which $ 94.3 million was long-term and $ 9.8 million was current. Financing liability information was as follows (dollars in thousands): June 30, 2024 December 31, 2023 Weighted average remaining lease term (in years) 17.3 17.8 Weighted average discount rate 9.0 % 9.0 % Three Months Six Months 2024 2023 2024 2023 Interest expense on financing liability $ 2,444 $ 2,449 $ 4,891 $ 4,873 The Company's remaining financing liability payments were as follows (in thousands): June 30, 2024 Remainder of 2024 $ 5,027 2025 10,269 2026 10,533 2027 10,849 2028 11,174 Thereafter 177,278 Total 225,130 Interest payments ( 118,530 ) Debt issuance costs ( 2,571 ) Total financing liability $ 104,029 Financing Lease — In May 2024, the Company acquired audio-visual equipment via a financing lease with de minimis monthly principal and interest payments and a termination date in May 2029. Financing lease information was as follows (dollars in thousands): June 30, 2024 Financing lease right-of-use asset (1) $ 222 Financing lease liability-current ( 2) $ 39 Financing lease liability-long-term 184 Total $ 223 Weighted average remaining lease term (in years) 4.9 Weighted average discount rate 7.3 % _________________________ (1) Financing right-of-use asset is included in other assets in the condensed consolidated balance sheets. (2) Financing lease liability – current is included in accrued expenses and other current liabilities in the condensed consolidated balance sheets. The Company's remaining financing lease payments were as follows (in thousands): June 30, 2024 Remainder of 2024 $ 27 2025 54 2026 54 2027 54 2028 54 Thereafter 23 Total 266 Interest payments ( 43 ) Total financing liability $ 223 Commitments — In July 2014, the Company entered into the Insulin Supply Agreement 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. In December 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 June 30, 2024 were as follows (€ in millions): June 30, 2024 Remaining Purchase Commitments Estimated Capacity Fees 2025 — 1.5 2026 (1) 4.2 2.0 2027 6.0 1.0 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 56.6 9.5 _________________________ (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 $ 60.2 million and $ 64.8 million is included in our condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023, 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 condensed 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): June 30, 2024 December 31, 2023 Operating lease right-of-use assets (1) $ 4,073 $ 4,685 Operating lease liability-current (2) $ 1,773 $ 1,423 Operating lease liability-long-term 3,272 3,925 Total $ 5,045 $ 5,348 Weighted average remaining lease term (in years) 3.4 3.7 Weighted average discount rate 7.3 % 7.3 % _________________________ (1) Operating right-of-use assets related to vehicles, offices and the manufacturing facility for V-Go are included in other assets in the condensed consolidated balance sheets. (2) Operating lease liability – current is included in accrued expenses and other current liabilities in the condensed consolidated balance sheets. Three Months Six Months 2024 2023 2024 2023 Operating lease costs $ 350 $ 410 $ 698 $ 831 Variable lease costs 9 13 19 49 Cash paid 314 234 546 557 The Company's future minimum office and vehicle lease payments were as follows (in thousands): June 30, 2024 Remainder of 2024 $ 918 2025 1,829 2026 1,213 2027 1,135 2028 643 Total 5,738 Interest expense ( 693 ) Total operating lease liability $ 5,045 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income Taxes During the three and six months ended June 30, 2024, the Company recorded income tax expense of $ 0.3 million and $ 0.6 million, respectively, related to state taxes, which was calculated using the discrete year-to-date method. The income tax provision for the three and six months ended June 30, 2023 resulted in no tax expense. The effective tax rate differs from the statutory tax rate of 21 % primarily due to the existence of valuation allowances against net deferred tax assets and current liabilities resulting from the estimated state income tax liabilities. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and concluded, in accordance with the applicable accounting standards, that net deferred tax assets should be fully reserved. The Company has assessed its position with regards to uncertainty in tax positions and has not recognized a liability for unrecognized tax benefits. 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 six months ended June 30, 2024 , the Company did no t recognize any interest or penalties. The Company’s tax years since 2019 remain subject to examination by tax authorities. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events On May 28, 2024, the Company executed a bill of sale and assignment agreement with Pulmatrix, Inc. (the "Seller") whereby the Company would acquire from the Seller certain lab assets and assume certain liabilities, including the lease for a R&D facility in Bedford, Massachusetts. Concurrently, the Company and the Seller entered into (i) an intellectual property cross-license agreement for the Company's out-licensing of its Cricket ® device to the Seller and in-licensing of the Seller's iSPERSE technology , (ii) an assignment and assumption of lease, and (iii) a master service agreement. The parties and Cobalt PropCo 2020 LLC, as landlord, also entered into an amendment to lease and consent to assignment of the lease. Each of these agreements became effective upon the closing of the collective transaction on July 8, 2024 (the "Effective Date"). The Company also entered into employment agreements with 13 Pulmatrix employees which began employment with the Company on the Effective Date. In June 2024, in anticipation of the facility lease assumption on the Effective Date, the Company transferred $ 0.7 million to a depository account at a financial institution to collateralize a conditional stand-by letter of credit as required under the lease. This amount is reflected as long-term restricted cash as of June 30, 2024. The lease term extends from the Effective Date through November 30, 2033 with monthly payments of $ 0.1 million increasing 3 % annually starting on December 1, 2024. The Company is in the process of assessing the fair values of the consideration paid and net assets acquired. |
Description of Business and S_2
Description of Business and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Business | Business — MannKind 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, UT, began commercializing Tyvaso DPI in June 2022 and is obligated to pay a 10 % royalty on net sales of the product, of which 9 % is allocated to the Company and 1 % to another party as detailed in Note 14 – Commitments and Contingencies . The Company also receives a margin on supplies of Tyvaso DPI that it manufactures for UT. |
Basis of Presentation | Basis of Presentation — The condensed consolidated financial statements have been prepared in accordance with GAAP. |
Principles of Consolidation | Principles of Consolidation — The condensed 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 the prior period have been reclassified to conform with current period presentation. The Company has separated non-cash accretion income on investments from other, net, and presented it as net accretion of investments in the condensed consolidated statements of cash flows. The Company has also presented amortization of debt issuance costs on financing liability with depreciation and amortization and non-cash interest accretion on financing liability on a net basis in other, net. Additionally, the Company has combined accruals for the Danbury facility buildout with other in Note 7 – Accrued Expenses and Other Current Liabilities . |
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 ("U.S."). |
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's Customers obtain control of product upon delivery for wholesale distributors and generally at delivery for specialty pharmacies. The Company transfers control and 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. 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 are made when changes in the Company's assumptions result in revised estimates. 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 and Product Sales”). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were considered bundled services under the Manufacturing Services and Product Sales 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 9 – 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 9 – 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 long-term commercial supply agreement with UT (as amended, the "CSA") 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 UT License Agreement (as defined in Note 9 – Collaboration, Licensing and Other Arrangements ) 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 only collects 9 % of future royalties due to its sale in December 2023 of 1 % of future royalties as detailed in Note 14 – Commitments and Contingencies . The Company’s net revenue and cost of revenue and goods sold as shown on the condensed consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands): Three Months Six Months 2024 2023 2024 2023 Net revenue: Product revenue (1) $ 46,758 $ 29,278 $ 89,986 $ 58,004 Services (2) 36 278 420 500 Royalties (3) 25,592 19,055 48,243 30,733 Total net revenue $ 72,386 $ 48,611 $ 138,649 $ 89,237 _________________________ (1) Amounts represent the 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 9) for UT as well as arrangements with other collaboration partners. See Note 9 – Collaboration, Licensing and Other Arrangements . (3) Amounts represent royalties on UT’s net revenue from Tyvaso DPI sales. Three Months Six Months 2024 2023 2024 2023 Cost of goods sold and cost of revenue: Product revenue $ 20,377 $ 13,995 $ 38,628 $ 30,023 Services — 242 347 427 Total cost of goods sold and cost of revenue $ 20,377 $ 14,237 $ 38,975 $ 30,450 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 short-term and long-term deferred revenue on its condensed consolidated balance sheets 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, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash — 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 June 30, 2024 and December 31, 2023, cash equivalents were comprised of money market funds, U.S. Treasury securities, corporate bonds and commercial paper with original maturities less than 90 days from the date of purchase. The Company records restricted cash when cash and cash equivalents are restricted as to withdrawal or usage. Restricted cash under a letter of credit issued in connection with a facility lease assumed by the Company that will not be available for use in the Company’s operations within 12 months of the reporting date is presented in non-current assets. See Note 16 – Subsequent Events. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported on the consolidated balance sheets that sum to amounts reported on the condensed consolidated statements of cash flows (in thousands): June 30, 2024 December 31, 2023 Cash and cash equivalents $ 96,643 $ 238,480 Restricted cash 732 — Total cash, cash equivalents and restricted cash $ 97,375 $ 238,480 |
Held-to-Maturity Investments | Held-to-Maturity Investments — The Company’s investments generally consist of commercial paper, corporate notes or bonds and U.S. Treasury securities. As of June 30, 2024 and December 31, 2023, 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 condensed consolidated balance sheets. The amortization or accretion of the Company’s investments is recognized as interest income in the condensed 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 issued by Thirona Bio, Inc. (“Thirona”). In January 2022, the Company purchased an additional $ 5.0 million convertible promissory note issued by Thirona (the “Thirona convertible notes”). The Thirona convertible notes are general unsecured obligations of Thirona and initially accrued interest at a rate of 6 % per annum. 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, and again on June 27, 2024 to extend the maturity date to June 30, 2026 and increase the interest rate to 10 % per annum. The Thirona convertible notes are classified as available-for-sale securities and included in other assets as of June 30, 2024 and prepaid expense and other current assets as of December 31, 2023 in the condensed 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 investment 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 pulmonary diseases. See Note 9 – 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 Losses | 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 regulatory approval 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. See Note 4 – Inventories. |
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 and included in cost of goods sold, research and development, and general and administrative expense in the condensed consolidated statements of operations. See Note 5 – 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. |
Acquisitions | 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 condensed consolidated financial statements. Leases are recorded at the net present value of the remaining lease payments. 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. |
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 14 – 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 June 30, 2024 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 10 – 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 condensed 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 7 – Accrued Expenses and Other Current Liabilities and Note 14 – 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 condensed 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 (Loss) Per Share of Common Stock | Net Income (Loss) Per Share of Common Stock — Basic net income or loss per share ("EPS") is calculated by dividing net income by the weighted average number of common shares outstanding for the period. Diluted EPS reflects the effect of potential common stock issuances resulting from assumed stock option exercises and vesting of restricted stock units, unless the effect is anti-dilutive, when applying the treasury stock method, as well as potential dilution under 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 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 believes this guidance will not have a material impact on its condensed 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 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 condensed consolidated financial statement disclosures. 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 condensed consolidated financial position or results of operations upon adoption. |
Description of Business and S_3
Description of Business and Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 condensed consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands): Three Months Six Months 2024 2023 2024 2023 Net revenue: Product revenue (1) $ 46,758 $ 29,278 $ 89,986 $ 58,004 Services (2) 36 278 420 500 Royalties (3) 25,592 19,055 48,243 30,733 Total net revenue $ 72,386 $ 48,611 $ 138,649 $ 89,237 _________________________ (1) Amounts represent the 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 9) for UT as well as arrangements with other collaboration partners. See Note 9 – Collaboration, Licensing and Other Arrangements . (3) Amounts represent royalties on UT’s net revenue from Tyvaso DPI sales. Three Months Six Months 2024 2023 2024 2023 Cost of goods sold and cost of revenue: Product revenue $ 20,377 $ 13,995 $ 38,628 $ 30,023 Services — 242 347 427 Total cost of goods sold and cost of revenue $ 20,377 $ 14,237 $ 38,975 $ 30,450 |
Schedule of Restrictions on Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported on the consolidated balance sheets that sum to amounts reported on the condensed consolidated statements of cash flows (in thousands): June 30, 2024 December 31, 2023 Cash and cash equivalents $ 96,643 $ 238,480 Restricted cash 732 — Total cash, cash equivalents and restricted cash $ 97,375 $ 238,480 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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): June 30, 2024 December 31, 2023 Amortized Aggregate Amortized Aggregate Due in one year or less (1) $ 231,331 $ 231,446 $ 115,263 $ 115,374 Due after one year through five years 13,398 13,478 7,155 7,197 Total $ 244,729 $ 244,924 $ 122,418 $ 122,571 ___________________________ (1) The investments due in one year or less include cash equivalents of $ 80.2 million as of June 30, 2024 and $ 58.6 million as of December 31, 2023 . |
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 (dollars in thousands). June 30, 2024 Investment Level Amortized Cost Gross Unrealized Holding Gross Unrealized Estimated Money market funds and other Level 1 $ 16,775 $ — $ — $ 16,775 Commercial bonds and paper Level 2 52,824 52 ( 69 ) 52,807 U.S. Treasury Securities Level 2 175,130 251 ( 39 ) 175,342 Total cash equivalents and investments 244,729 303 ( 108 ) 244,924 Less: cash equivalents ( 80,213 ) — — ( 80,213 ) Total Investments $ 164,516 $ 303 $ ( 108 ) $ 164,711 December 31, 2023 Investment Level Amortized Cost Gross Unrealized Holding Gross Unrealized Estimated Money market funds Level 1 $ 69,611 $ — $ — $ 69,611 Commercial bonds and paper Level 2 43,251 135 ( 38 ) 43,348 U.S. Treasury Securities Level 2 9,556 56 — 9,612 Total cash equivalents and investments 122,418 191 ( 38 ) 122,571 Less: cash equivalents ( 58,644 ) — — ( 58,644 ) Total Investments $ 63,774 $ 191 $ ( 38 ) $ 63,927 |
Accounts Receivable (Tables)
Accounts Receivable (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Receivables [Abstract] | |
Schedule of Accounts Receivable, Net | Accounts receivable, net consists of the following (in thousands): June 30, 2024 December 31, 2023 Accounts receivable – commercial Accounts receivable, gross $ 22,270 $ 20,199 Wholesaler distribution fees and prompt pay discounts ( 3,750 ) ( 2,469 ) Reserve for returns ( 6,798 ) ( 6,215 ) Allowance for credit losses ( 157 ) ( 157 ) Total accounts receivable – commercial, net 11,565 11,358 Accounts receivable – collaborations and services 11,781 3,543 Total accounts receivable, net $ 23,346 $ 14,901 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventories consist of the following (in thousands): June 30, 2024 December 31, 2023 Raw materials $ 5,984 $ 6,262 Work-in-process 9,784 13,646 Finished goods 8,985 8,637 Total inventory $ 24,753 $ 28,545 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment consisted of the following (dollars in thousands): Estimated Useful Life (Years) June 30, 2024 December 31, 2023 Land — $ 875 $ 875 Buildings 39 - 40 17,389 17,389 Building improvements (1) 5 - 40 89,886 46,357 Machinery and equipment 3 - 15 64,983 60,410 Furniture, fixtures and office equipment 5 - 10 3,070 3,070 Computer equipment and software 3 8,677 8,658 Construction in progress (1) — 4,799 48,997 Total property and equipment 189,679 185,756 Less accumulated depreciation ( 104,535 ) ( 101,536 ) Total property and equipment, net $ 85,144 $ 84,220 ___________________________ (1) During the six months ended June 30, 2024 , the Company transferred $ 43.4 million from construction in progress to building improvements for assets placed in service related to the expansion of the Company's manufacturing facility. |
Depreciation Expense Related to Property and Equipment | Depreciation expense related to property and equipment was as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 Depreciation Expense $ 1,711 $ 1,095 $ 3,052 $ 2,133 |
Goodwill and Other Intangible_2
Goodwill and Other Intangible Asset (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Other Intangible Asset | Other Intangible Asset — Other intangible asset consisted of the following (dollars in thousands): Estimated June 30, 2024 December 31, 2023 Useful Cost Accumulated Net Book Value Cost Accumulated Net Book Value Developed technology 15 $ 1,200 $ ( 167 ) $ 1,033 $ 1,200 $ ( 127 ) $ 1,073 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities were comprised of the following (in thousands): June 30, 2024 December 31, 2023 Salary and related expenses $ 12,656 $ 19,506 Discounts and allowances for commercial product sales 10,965 9,541 Accrued interest (1) 6,165 2,153 Deferred lease liability 1,812 1,423 Current portion of milestone rights liability (2) 1,391 752 Returns reserve for acquired product (3) 1,290 601 Professional fees 656 979 State income tax liability 424 1,561 Other 5,593 5,520 Accrued expenses and other current liabilities $ 40,952 $ 42,036 _________________________ (1) As of June 30, 2024, accrued interest includes $ 4.2 million related to a milestone payment of $ 5.0 million to be paid in the third quarter of 2024. See Note 14 – Commitments and Contingencies under Milestone Rights . (2) As of June 30, 2024, the current portion of milestone rights liability includes $ 0.8 million to be paid in the third quarter of 2024 and $ 0.6 million reclassified from long-term to short-term milestone right liability. (3) See Note 14 – Commitments and Contingencies under Loss Contingencies — Returns Reserve for Acquired Product . |
Borrowings (Tables)
Borrowings (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Summary of Carrying Amount of Borrowings | Carrying amount of the Company's borrowings consisted of the following (in thousands): June 30, 2024 December 31, 2023 Senior convertible notes $ 227,577 $ 226,851 MidCap credit facility — 33,019 Mann Group convertible note — 8,829 Total debt – net carrying amount $ 227,577 $ 268,699 |
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 June 30, 2024 December 31, 2023 Annual Interest Maturity Date Conversion Price Senior convertible notes $ 230.0 million $ 230.0 million 2.50 % March 2026 $ 5.21 MidCap credit facility (1) $ — $ 33.3 million one-month 1 % floor) 6.25 %; 8.25 % August 2025 N/A Mann Group convertible note (2) $ — $ 8.8 million 2.50 % December 2025 $ 2.50 _________________________ (1) Repaid on April 1, 2024. (2) Repaid on April 2, 2024. |
Schedule of Maturities of Company's Borrowings | The maturities of the Company’s borrowings as of June 30, 2024 are as follows (in thousands): Amounts Remainder of 2024 $ — 2025 — 2026 230,000 Total principal payments 230,000 Debt issuance costs ( 2,423 ) Total debt $ 227,577 |
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 were as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 Amortization of debt discount and prepayment fee $ — $ 108 $ 85 $ 214 Amortization of debt issuance cost 363 363 726 727 |
Collaboration, Licensing and _2
Collaboration, Licensing and Other Arrangements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Schedule of Revenue from Collaboration and Services | Revenue from collaborations and services were as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 UT CSA (1) $ 25,978 $ 10,933 $ 50,442 $ 22,097 UT License Agreement (2) — 242 347 427 Cipla License and Distribution Agreement 36 36 73 73 Total revenue from collaborations and services $ 26,014 $ 11,211 $ 50,862 $ 22,597 _________________________ (1) Amounts consist of revenue recognized for Manufacturing Services and Product Sales 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 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 Product Sales 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 and Product Sales 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 and Product Sales 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 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Schedule of Revenue from Collaboration and Services | Total revenue from UT was as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 UT Revenue UT CSA $ 25,978 $ 10,933 $ 50,442 $ 22,097 UT License Agreement — 242 347 427 Royalties – Collaboration (1) 25,592 19,055 48,243 30,733 Total revenue from UT $ 51,570 $ 30,230 $ 99,032 $ 53,257 _________________________ (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 condensed consolidated balance sheets. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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): June 30, 2024 Fair Value Carrying Value Significant Financial liabilities: Senior convertible notes (1) $ 227.6 $ 258.9 Milestone rights (2) 3.9 10.6 Contingent milestone liability (3) 0.3 0.3 Financing liability (4) 104.0 106.6 Liability for sale of future royalties (5) 147.5 163.9 _________________________ (1) Fair value was determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 11.0 %, volatility of 53.0 % 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 $ 253.0 million and $ 265.0 million, respectively. (2) Fair value was determined by applying a Monte Carlo simul ation 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 4.3 %, dividend yield of 0.0 %, volatility of 50.0 %, period of 7.5 years and credit risk of 15.0 %. (3) Fair value was determined by 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 4.5 %, dividend yield of 0.0 %, volatility of 60.0 %, period of 13.5 years and credit risk of 15.0 %. (4) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 9.5 %. A change in yield of + or – 2 % would result in a fair value of $ 94.0 million and $ 122.1 million, respectively. (5) At June 30, 2024, fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 11.0 %. A change in yield of + or – 2 % would result in a fair value of $ 144.1 million and $ 188.3 million, respectively. At December 31, 2023, the carrying value approximated the fair value. December 31, 2023 Fair Value Carrying Value 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 11.0 %, 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 12.0 %. 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 13.0 % 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 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 3.9 %, dividend yield of 0.0 %, volatility of 50.0 %, period of 8 years and credit risk of 17.0 %. (5) Fair value was determined by 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 4.0 %, dividend yield of 0.0 %, volatility of 43.0 %, period of 15 years and credit risk of 17.0 %. (6) Fair value was determined by applying a discounted cash flow analysis with a hypothetical yield of 9.5 %. |
Earnings Per Common Share (Tabl
Earnings Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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): Three Months Six Months 2024 2023 2024 2023 EPS — basic: Net income (loss) (numerator) $ ( 2,014 ) $ ( 5,265 ) $ 8,616 $ ( 15,060 ) Weighted average common shares (denominator) 273,056 265,626 271,706 264,802 Net income (loss) per share $ ( 0.01 ) $ ( 0.02 ) $ 0.03 $ ( 0.06 ) EPS — diluted: Net income (loss) — basic $ ( 2,014 ) $ ( 5,265 ) $ 8,616 $ ( 15,060 ) Weighted average common shares 273,056 265,626 271,706 264,802 Effect of dilutive securities — common shares issuable — — 7,652 — Adjusted weighted average common shares (denominator) 273,056 265,626 279,358 264,802 Net income (loss) per share $ ( 0.01 ) $ ( 0.02 ) $ 0.03 $ ( 0.06 ) For the six months ended June 30, 2024 , diluted net income per share excluded the weighted average effect of 7.8 million RSUs and Market RSUs, 1.9 million options and PNQs and 44.1 million common shares issuable upon conversion of our Senior convertible notes, as they were antidilutive. |
Potential Dilutive Securities Outstanding that are Considered Antidilutive | Potentially dilutive securities outstanding which were considered antidilutive due to the net losses incurred for the three months ended June 30, 2024 and three and six months ended June 30, 2023 are summarized as follows (in shares): June 30, 2024 2023 Senior convertible notes 44,120,463 44,120,463 RSUs and Market RSUs (1) 16,750,557 16,951,734 Common stock options and PNQs 7,920,453 8,688,625 Mann Group convertible notes — 3,370,000 Total shares 68,791,473 73,130,822 __________________________ (1) Market RSUs issued in 2021, 2022 and 2023 are included at the share delivery of 194 %, 178 % and 100 %, respectively, in accordance with a valuation assessment obtained as of June 30, 2024. |
Stock-Based Compensation Expe_2
Stock-Based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Employee Awards and Non-employee Director Award Plan Activity | The Company granted the following awards (in shares): Three Months Ended Three Months Ended Six Months Ended 2024 2024 2024 Employee awards: RSUs 267,990 (1) 3,205,910 (2) 3,473,900 Market RSUs — 2,144,000 (3) 2,144,000 Non-employee director RSUs — 280,376 (4) 280,376 Total awards issued 267,990 5,630,286 5,898,276 _________________________ (1) RSUs had a weighted average grant date fair value of $ 3.28 per share, of which 211,895 RSUs had a vesting period of 33.3 % annually over the second , third , and fourth anniversary of the vesting determination date, 53,720 RSUs had a cliff vesting period of three years , and 2,375 RSUs had a vesting period of 25 % annually over four years . (2) RSUs had a weighted average grant date fair value of $ 4.45 per share, of which 3,033,680 RSUs had a vesting period of 25 % annually over four years , 145,980 RSUs had a vesting period of 33.3 % annually over the second , third , and fourth anniversary of the vesting determination date, and 26,250 RSUs had a cliff vesting period of two years . (3) Market RSUs had a grant date fair value of $ 10.30 per share and will vest on July 15, 202 7 . 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, 2024 until June 30, 2027 relative to the TSR of the Russell 3000 Pharmaceutical & Biotechnology Index over the same three-year period, as follows: less than 25th percentile= 0 % of target, 25th percentile= 50 % of target, 50th percentile= 100 % of target, 75th percentile= 200 % of target, 90th percentile or higher= 300 % maximum. Payout values will be interpolated between the percentile rankings above. (4) RSUs had a weighted average grant date fair value of $ 4.45 per share and vested immediately upon the grant date; however, the underlying shares of common stock will not be delivered until there is a separation of service such as resignation, retirement or death. |
Stock Based Compensation Expense Recognized in Condensed Consolidated Statements of Operations | Total stock-based compensation expense recognized in the condensed consolidated statements of operations as cost of goods sold, cost of revenue – collaborations and services, R&D and selling, general and administrative expense was as follows (in thousands): Three Months Six Months 2024 2023 2024 2023 RSUs and options $ 6,248 $ 5,404 $ 9,947 $ 8,882 Employee stock purchase plan 180 176 366 353 Total $ 6,428 $ 5,580 $ 10,313 $ 9,235 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Commitments And Contingencies [Line Items] | |
Schedule Of Royalty Liability Account Roll Forward | The following table shows the activity within the Royalty Liability account during the six months ended June 30, 2024 as well as the effective interest rate (dollars in thousands): Balance, January 1, 2024 $ 145,810 Amortization of deferred transaction costs 114 Non-cash interest expense on liability for sale of future royalties 8,517 Royalty revenue earned by or payable to Sagard ( 6,927 ) Balance, June 30, 2024 $ 147,514 Effective interest rate 11.1 % — 11.5 % |
Schedule of Lease Term and Discount Rate | Financing liability information was as follows (dollars in thousands): June 30, 2024 December 31, 2023 Weighted average remaining lease term (in years) 17.3 17.8 Weighted average discount rate 9.0 % 9.0 % Lease information was as follows (dollars in thousands): June 30, 2024 December 31, 2023 Operating lease right-of-use assets (1) $ 4,073 $ 4,685 Operating lease liability-current (2) $ 1,773 $ 1,423 Operating lease liability-long-term 3,272 3,925 Total $ 5,045 $ 5,348 Weighted average remaining lease term (in years) 3.4 3.7 Weighted average discount rate 7.3 % 7.3 % _________________________ (1) Operating right-of-use assets related to vehicles, offices and the manufacturing facility for V-Go are included in other assets in the condensed consolidated balance sheets. (2) Operating lease liability – current is included in accrued expenses and other current liabilities in the condensed consolidated balance sheets. |
Summary of Lease Information | Three Months Six Months 2024 2023 2024 2023 Interest expense on financing liability $ 2,444 $ 2,449 $ 4,891 $ 4,873 Three Months Six Months 2024 2023 2024 2023 Operating lease costs $ 350 $ 410 $ 698 $ 831 Variable lease costs 9 13 19 49 Cash paid 314 234 546 557 |
Summary of Remaining Financing Liability Payments | The Company's remaining financing liability payments were as follows (in thousands): June 30, 2024 Remainder of 2024 $ 5,027 2025 10,269 2026 10,533 2027 10,849 2028 11,174 Thereafter 177,278 Total 225,130 Interest payments ( 118,530 ) Debt issuance costs ( 2,571 ) Total financing liability $ 104,029 |
Summary of Financing Lease Information | Financing lease information was as follows (dollars in thousands): June 30, 2024 Financing lease right-of-use asset (1) $ 222 Financing lease liability-current ( 2) $ 39 Financing lease liability-long-term 184 Total $ 223 Weighted average remaining lease term (in years) 4.9 Weighted average discount rate 7.3 % _________________________ (1) Financing right-of-use asset is included in other assets in the condensed consolidated balance sheets. (2) Financing lease liability – current is included in accrued expenses and other current liabilities in the condensed consolidated balance sheets. |
Remaining Purchase Commitments and Estimated Capacity Fee Liability Requirements | The Company's remaining purchase commitments and estimated capacity fee liability as of June 30, 2024 were as follows (€ in millions): June 30, 2024 Remaining Purchase Commitments Estimated Capacity Fees 2025 — 1.5 2026 (1) 4.2 2.0 2027 6.0 1.0 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 56.6 9.5 _________________________ 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): June 30, 2024 Remainder of 2024 $ 918 2025 1,829 2026 1,213 2027 1,135 2028 643 Total 5,738 Interest expense ( 693 ) Total operating lease liability $ 5,045 |
Audio Visual Equipment | |
Commitments And Contingencies [Line Items] | |
Summary of Remaining Financing Liability Payments | The Company's remaining financing lease payments were as follows (in thousands): June 30, 2024 Remainder of 2024 $ 27 2025 54 2026 54 2027 54 2028 54 Thereafter 23 Total 266 Interest payments ( 43 ) Total financing liability $ 223 |
Description of Business and S_4
Description of Business and Significant Accounting Policies - Additional Information (Detail) € in Millions, $ in Millions | 1 Months Ended | 6 Months Ended | |||||
Jun. 27, 2024 | Dec. 31, 2023 USD ($) | Jan. 31, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2024 USD ($) Segment | Jun. 30, 2024 EUR (€) | Jul. 01, 2013 USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Percentage of future royalties | 1% | ||||||
Number of operating segment | Segment | 1 | ||||||
Loss on purchase commitments | € | € 56.6 | ||||||
Sagard | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Percentage of royalty on net sales | 1% | ||||||
Percentage of royalty on future net sales | 1% | ||||||
Insulin | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Loss on purchase commitments | $ 64.8 | $ 60.2 | |||||
Tyvaso DPI | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Percentage of royalty on net sales | 10% | ||||||
Percentage of royalty on future net sales | 9% | ||||||
Percentage of royalty on net revenue | 10% | ||||||
Percentage of future royalties | 9% | ||||||
Maximum | AFREZZA product sales | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Sales return right following product expiration in months | 12 months | ||||||
Minimum | AFREZZA product sales | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Sales return right following product expiration in months | 6 months | ||||||
Convertible Promissory Note | Thirona Bio, Inc. | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Increased interest rate | 10% | ||||||
Principal amount | $ 8 | ||||||
Purchase of available-for-sale securities | $ 5 | $ 3 | |||||
Interest rate | 6% | ||||||
MidCap Credit Facility | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Principal amount | $ 33.3 | ||||||
Milestone Rights Liability | Deerfield | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Contingent liability remain payable | $ 55 | ||||||
Milestone Rights Liability | Maximum | Deerfield | |||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||
Contingent liability for milestone payments | $ 90 |
Description of Business and S_5
Description of Business and Significant Accounting Policies - Additional Information (Detail 1) - Collaborations and services | Jun. 30, 2024 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2023-04-01 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Remaining performance obligation, Expected timing of satisfaction, period | 12 months |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2024-04-01 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Remaining performance obligation, Expected timing of satisfaction, period | 12 months |
Description of Business and S_6
Description of Business and Significant Accounting Policies - Summary of Revenue and Cost of Revenue and Goods Sold Generated From Product Sales, Services and Royalties (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Disaggregation Of Revenue [Line Items] | ||||
Total net revenue | $ 72,386 | $ 48,611 | $ 138,649 | $ 89,237 |
Total cost of goods sold and cost of revenue | 20,377 | 14,237 | 38,975 | 30,450 |
Product Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenue | 46,758 | 29,278 | 89,986 | 58,004 |
Total cost of goods sold and cost of revenue | 20,377 | 13,995 | 38,628 | 30,023 |
Services | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenue | 36 | 278 | 420 | 500 |
Total cost of goods sold and cost of revenue | 0 | 242 | 347 | 427 |
Royalties | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenue | $ 25,592 | $ 19,055 | $ 48,243 | $ 30,733 |
Description of Business and S_7
Description of Business and Significant Accounting Policies - Schedule of Restrictions on Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Statement Of Financial Position [Abstract] | ||
Cash and cash equivalents | $ 96,643 | $ 238,480 |
Restricted cash | 732 | |
Total cash, cash equivalents and restricted cash | $ 97,375 | $ 238,480 |
Acquisition - Additional Inform
Acquisition - Additional Information (Detail) | Jun. 30, 2024 | Dec. 31, 2023 |
Business Acquisition [Line Items] | ||
Incremental borrowing rate | 7.30% | 7.30% |
Acquisition - Schedule of Preli
Acquisition - Schedule of Preliminary Amounts of Identifiable Assets Acquired and Liabilities Assumed (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Assets: | ||
Goodwill | $ 1,931 | $ 1,931 |
Investments - Additional Inform
Investments - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) Note | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Schedule Of Investments [Line Items] | |||||
Interest on held to maturity investments | $ 3,200,000 | $ 1,400,000 | $ 6,600,000 | $ 2,600,000 | |
Net accretion on investments held to maturity | 2,000,000 | 400,000 | 3,800,000 | 400,000 | |
Allowance for credit losses | 0 | 0 | $ 0 | ||
Prepaid Expenses and Other Current Assets | |||||
Schedule Of Investments [Line Items] | |||||
Accrued interest receivable | $ 800,000 | $ 800,000 | $ 500,000 | ||
Convertible Promissory Note | Thirona Bio, Inc. | |||||
Schedule Of Investments [Line Items] | |||||
Hypothetical yield percentage | 33 | 33 | 35 | ||
Volatility percentage | 75 | 75 | 90 | ||
Interest on available for sale investment | $ 0 | 100,000 | $ 0 | 200,000 | |
Number of notes | Note | 2 | ||||
Amount Due | $ 8,000,000 | $ 8,000,000 | |||
Stated interest rate | 10% | 10% | |||
Investment securities | $ 5,300,000 | $ 5,300,000 | $ 6,900,000 | ||
Recognized gain (loss) | $ (1,600,000) | 900,000 | $ (1,600,000) | 900,000 | |
Unrealized holding gain | $ 400,000 | $ 400,000 |
Investments - Schedule of Contr
Investments - Schedule of Contractual Maturities of Held to Maturity Investments (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | |
Debt Securities, Held-to-Maturity, Maturity [Abstract] | |||
Amortized cost basis, due in one year or less | [1] | $ 231,331 | $ 115,263 |
Amortized cost basis due after one year through five years | 13,398 | 7,155 | |
Amortized cost basis, total | 244,729 | 122,418 | |
Aggregate fair value, due in one year or less | [1] | 231,446 | 115,374 |
Aggregate fair value, due after one year through five years | 13,478 | 7,197 | |
Aggregate fair value, total | $ 244,924 | $ 122,571 | |
[1] The investments due in one year or less include cash equivalents of $ 80.2 million as of June 30, 2024 and $ 58.6 million as of December 31, 2023 . |
Investments - Schedule of Con_2
Investments - Schedule of Contractual Maturities of Held to Maturity Investments (Parenthetical) (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Schedule of Held-to-Maturity Securities [Line Items] | ||
Cash and cash equivalents | $ 96,643 | $ 238,480 |
Due in One Year or Less | ||
Schedule of Held-to-Maturity Securities [Line Items] | ||
Cash and cash equivalents | $ 80,200 | $ 58,600 |
Investments - Schedule of Fair
Investments - Schedule of Fair Value of Cash Equivalents, Long and Short Term Investments (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Amortized Cost | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | $ 244,729 | $ 122,418 |
Less: cash equivalents | (80,213) | (58,644) |
Total Investments | 164,516 | 63,774 |
Amortized Cost | Money Market Funds | Fair Value, Inputs, Level 1 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 16,775 | 69,611 |
Amortized Cost | Commercial Bonds and Paper | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 52,824 | 43,251 |
Amortized Cost | U.S. Treasury Securities | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 175,130 | 9,556 |
Gross Unrealized Holding Gains | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 303 | 191 |
Total Investments | 303 | 191 |
Gross Unrealized Holding Gains | Commercial Bonds and Paper | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 52 | 135 |
Gross Unrealized Holding Gains | U.S. Treasury Securities | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 251 | 56 |
Gross Unrealized Holding Losses | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | (108) | (38) |
Total Investments | (108) | (38) |
Gross Unrealized Holding Losses | Commercial Bonds and Paper | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | (69) | (38) |
Gross Unrealized Holding Losses | U.S. Treasury Securities | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | (39) | |
Estimated Fair Value | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 244,924 | 122,571 |
Less: cash equivalents | (80,213) | (58,644) |
Total Investments | 164,711 | 63,927 |
Estimated Fair Value | Money Market Funds | Fair Value, Inputs, Level 1 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 16,775 | 69,611 |
Estimated Fair Value | Commercial Bonds and Paper | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | 52,807 | 43,348 |
Estimated Fair Value | U.S. Treasury Securities | Fair Value, Inputs, Level 2 | ||
Schedule Of Investments [Line Items] | ||
Total cash equivalents and investments | $ 175,342 | $ 9,612 |
Schedule of Accounts Receivable
Schedule of Accounts Receivable, Net (Detail) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Accounts Receivable [Line Items] | ||
Allowance for credit losses | $ 0 | $ 0 |
Total accounts receivable, net | 23,346,000 | 14,901,000 |
Commercial product sales | ||
Accounts Receivable [Line Items] | ||
Accounts receivable, gross | 22,270,000 | 20,199,000 |
Wholesaler distribution fees and prompt pay discounts | (3,750,000) | (2,469,000) |
Reserve for returns | (6,798,000) | (6,215,000) |
Allowance for credit losses | (157,000) | (157,000) |
Total accounts receivable, net | 11,565,000 | 11,358,000 |
Collaborations and services | ||
Accounts Receivable [Line Items] | ||
Total accounts receivable, net | $ 11,781,000 | $ 3,543,000 |
Accounts Receivable - Additiona
Accounts Receivable - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) Distributor | Dec. 31, 2023 USD ($) Distributor | |
Accounts Receivable [Line Items] | |||
Number of wholesale distributors | Distributor | 3 | 3 | |
Percentage of gross sales from major wholesale distributors | 71% | 70% | |
Allowance for credit losses and doubtful accounts | $ 0 | $ 0 | $ 0 |
Percentage of revenue from major customers collaborations and services | 100% | 100% | |
Zealand Pharma US | |||
Accounts Receivable [Line Items] | |||
Allowance for credit losses and doubtful accounts | $ 200,000 | $ 200,000 | $ 200,000 |
United Therapeutics Corporation | |||
Accounts Receivable [Line Items] | |||
Percentage of collaborations and services net accounts receivables | 100% | 100% | |
Commercial product sales | |||
Accounts Receivable [Line Items] | |||
Percentage of accounts receivable from major wholesale distributors | 84% | 84% | |
Allowance for credit losses and doubtful accounts | $ 157,000 | $ 157,000 | $ 157,000 |
Accounts receivable | $ 22,270,000 | $ 22,270,000 | $ 20,199,000 |
Inventories - Components of Inv
Inventories - Components of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 5,984 | $ 6,262 |
Work-in-process | 9,784 | 13,646 |
Finished goods | 8,985 | 8,637 |
Total inventory | $ 24,753 | $ 28,545 |
Inventories - Additional Inform
Inventories - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Inventory [Line Items] | |||||
Inventory write-offs | $ 600 | $ 1,000 | $ 1,618 | $ 3,359 | |
Pre-launch Inventory | |||||
Inventory [Line Items] | |||||
Raw materials inventory | $ 800 | $ 800 | $ 800 |
Property and Equipment, Net (De
Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 189,679 | $ 185,756 |
Less accumulated depreciation | (104,535) | (101,536) |
Total property and equipment, net | 85,144 | 84,220 |
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 | $ 89,886 | 46,357 |
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 | $ 64,983 | 60,410 |
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 | 3,070 |
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 | $ 8,677 | 8,658 |
Estimated Useful Life (Years) | 3 years | |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 4,799 | $ 48,997 |
Property and Equipment, Net (Pa
Property and Equipment, Net (Parenthetical) (Detail) $ in Millions | Jun. 30, 2024 USD ($) |
UT Manufacturing Facility | |
Property Plant And Equipment [Line Items] | |
Amount transferred from construction in progress to building improvements | $ 43.4 |
Depreciation Expense Related to
Depreciation Expense Related to Property and Equipment (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation Expense | $ 1,711 | $ 1,095 | $ 3,052 | $ 2,133 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Property Plant And Equipment [Line Items] | ||||
Amount of divestiture of long-lived | $ 0 | $ 0 | ||
Manufacturing Equipment | ||||
Property Plant And Equipment [Line Items] | ||||
Amount of divestiture of long-lived | $ 100,000 | $ 100,000 |
Goodwill and Other Intangible_3
Goodwill and Other Intangible Asset - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Goodwill | $ 1,931 | $ 1,931 |
2024 | 100 | |
2025 | 100 | |
2026 | 100 | |
2027 | 100 | |
2028 | 100 | |
After 2028 | $ 600 |
Goodwill and Other Intangible_4
Goodwill and Other Intangible Asset - Summary of Other Intangible Asset (Detail) - Developed Technology - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Finite Lived Intangible Assets [Line Items] | ||
Estimated Useful Life (Years) | 15 years | |
Cost | $ 1,200 | $ 1,200 |
Accumulated Amortization | (167) | (127) |
Net Book Value | $ 1,033 | $ 1,073 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | |
Payables And Accruals [Abstract] | |||
Salary and related expenses | $ 12,656 | $ 19,506 | |
Discounts and allowances for commercial product sales | 10,965 | 9,541 | |
Accrued interest | 6,165 | 2,153 | |
Deferred lease liability | 1,812 | 1,423 | |
Current portion of milestone rights liability | 1,391 | 752 | |
Returns reserve for acquired product | [1] | 1,290 | 601 |
Professional fees | 656 | 979 | |
State income tax liability | 424 | 1,561 | |
Other | 5,593 | 5,520 | |
Accrued expenses and other current liabilities | $ 40,952 | $ 42,036 | |
[1] See Note 14 – Commitments and Contingencies under Loss Contingencies — Returns Reserve for Acquired Product . |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities (Parenthetical) (Detail) $ in Millions | Jun. 30, 2024 USD ($) |
Accrued Expenses and Other Current Liabilities [Line Items] | |
Milestone Rights Payment | $ 5 |
Milestone rights liability to be paid | 0.8 |
Short Term Milestone Right Liability | 0.6 |
Accrued interest | |
Accrued Expenses and Other Current Liabilities [Line Items] | |
Milestone Rights Payment | $ 4.2 |
Borrowings - Summary of Carryin
Borrowings - Summary of Carrying Amount of Borrowings (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | ||
Senior convertible notes | $ 227,577 | $ 226,851 |
Mann Group convertible note | 227,577 | 226,851 |
Total debt — net carrying amount | $ 227,577 | 268,699 |
MidCap Credit Facility | ||
Debt Instrument [Line Items] | ||
Credit Facility | 33,019 | |
Related Party | ||
Debt Instrument [Line Items] | ||
Mann Group convertible note | $ 8,829 |
Borrowings - Schedule of Line o
Borrowings - Schedule of Line of Credit Facility Debt and Key Terms (Detail) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |||
Jun. 30, 2024 | Apr. 02, 2024 | Dec. 31, 2023 | Mar. 04, 2021 | |
Senior Convertible Notes | ||||
Debt Instrument [Line Items] | ||||
Amount Due | $ 230 | $ 230 | ||
Annual interest rate | 2.50% | |||
Maturity date | 2026-03 | |||
Conversion price | $ 5.21 | $ 5.21 | ||
MidCap Credit Facility | ||||
Debt Instrument [Line Items] | ||||
Amount Due | 33.3 | |||
Maturity date | 2025-08 | |||
SOFR | MidCap Credit Facility | ||||
Debt Instrument [Line Items] | ||||
Annual interest rate | 6.25% | |||
Interest rate floor | 1% | |||
Interest rate cap | 8.25% | |||
The Mann Group L L C | ||||
Debt Instrument [Line Items] | ||||
Conversion price | $ 2.5 | |||
The Mann Group L L C | Convertible Promissory Note | ||||
Debt Instrument [Line Items] | ||||
Amount Due | $ 8.8 | |||
Annual interest rate | 2.50% | |||
Maturity date | 2025-12 | |||
Conversion price | $ 2.5 |
Borrowings - Schedule of Maturi
Borrowings - Schedule of Maturities of Company's Borrowings (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
Remainder of 2024 | $ 0 | |
2025 | 0 | |
2026 | 230,000 | |
Total principal payments | 230,000 | |
Debt issuance costs | (2,423) | |
Total debt — net carrying amount | $ 227,577 | $ 268,699 |
Borrowings - Senior Convertible
Borrowings - Senior Convertible Notes - Additional Information (Detail) | 1 Months Ended | 6 Months Ended | |||
Mar. 04, 2021 USD ($) d $ / shares | Aug. 31, 2019 | Jun. 30, 2024 USD ($) d $ / shares | Dec. 31, 2023 USD ($) $ / shares | Mar. 31, 2021 USD ($) | |
Debt Instrument [Line Items] | |||||
Maturity date | Dec. 31, 2025 | ||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||
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% | ||||
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 | $ 2,400,000 | $ 3,100,000 | |||
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) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Apr. 01, 2024 USD ($) | Apr. 30, 2021 USD ($) | Dec. 31, 2020 Installment | Aug. 31, 2019 USD ($) Installment | Jun. 30, 2024 USD ($) | Mar. 31, 2024 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2020 USD ($) | |
Debt Instrument [Line Items] | ||||||||
Maturity date | Dec. 31, 2025 | |||||||
Debt instrument payment term description | Principal on each term loan advance under Tranche 1 and Tranche 2 was payable in 24 equal monthly installments that began September 1, 2023. | |||||||
Loss on extinguishment of debt | $ (7,050) | $ (7,050) | ||||||
MidCap Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepaid of borrowing | $ 10,000 | |||||||
Debt Instrument unamortized prepayment penalty. | $ 200 | |||||||
Debt Instrument, Repaid, Principal | 28,300 | |||||||
Accrued Interest | 200 | |||||||
Principal payment on MidCap credit facility | $ 5,000 | |||||||
Payment of credit facility exit fee | 2,800 | |||||||
Payment of credit facility prepayment fee | 300 | |||||||
Loss on extinguishment of debt | 3,300 | |||||||
Repayment of debt | $ 31,600 | |||||||
Early termination fees, percentage | 1% | |||||||
MidCap Credit Facility | SOFR | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate floor | 1% | |||||||
Tranche 1 | ||||||||
Debt Instrument [Line Items] | ||||||||
Annual interest rate | 8.25% | |||||||
Debt payable 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] | ||||||||
Interest rate (LIBOR) | 6.25% | |||||||
Interest rate floor | 1% | |||||||
Tranche 1 | MidCap Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Advance of borrowing | $ 40,000 | |||||||
Debt instrument, prepayment penalty percentage | 7% | |||||||
Debt instrument, prepayment penalty | $ 40,000 | |||||||
Tranche 2 | ||||||||
Debt Instrument [Line Items] | ||||||||
Annual interest rate | 8.25% | 8.25% | ||||||
Debt payable 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] | ||||||||
Interest rate (LIBOR) | 6.25% | |||||||
Interest rate floor | 1% | |||||||
Tranche 2 | MidCap Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Advance of borrowing | $ 10,000 |
Borrowings - Mann Group Promiss
Borrowings - Mann Group Promissory Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Apr. 02, 2024 USD ($) $ / shares shares | Aug. 31, 2019 USD ($) $ / shares | Jun. 30, 2024 USD ($) $ / shares | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) shares | Dec. 31, 2023 USD ($) | |
Debt Instrument [Line Items] | ||||||
Debt instrument payment term description | Principal on each term loan advance under Tranche 1 and Tranche 2 was payable in 24 equal monthly installments that began September 1, 2023. | |||||
Maturity date | Dec. 31, 2025 | |||||
Loss on extinguishment of debt | $ (7,050) | $ (7,050) | ||||
The Mann Group L L C | ||||||
Debt Instrument [Line Items] | ||||||
Loss on extinguishment of debt | $ 3,700 | |||||
Debt instrument remaining principal and interest after conversion | $ 5,100 | |||||
Conversion price | $ / shares | $ 2.5 | |||||
Debt issuance amount | $ 8,900 | |||||
Conversion of notes to common shares, shares | shares | 1,500,000 | |||||
convertible note plus accrued interest | $ 8,900 | |||||
Convertible shares of common stock | shares | 3,554,198 | |||||
Market value of common stock | shares | 2,054,198 | |||||
The Mann Group L L C | Convertible Promissory Note | ||||||
Debt Instrument [Line Items] | ||||||
Principal amount | $ 8,800 | |||||
Senior notes, effective interest rate | 2.50% | 2.50% | ||||
Conversion price | $ / shares | $ 2.5 | $ 2.5 | ||||
Conversion of notes to common shares, shares | shares | 15,285 | 23,683 | ||||
The Mann Group L L C | Convertible Promissory Note | Accrued Interest | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance amount | $ 100 | $ 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% | |||||
Debt instrument payment term description | quarterly | |||||
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 |
Borrowings - Schedule of Amorti
Borrowings - Schedule of Amortization of Premium and Accretion of Debt Issuance Costs (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Debt Disclosure [Abstract] | ||||
Amortization of debt discount and prepayment fee | $ 108 | $ 85 | $ 214 | |
Amortization of debt issuance cost | $ 363 | $ 363 | $ 726 | $ 727 |
Collaboration, Licensing and _3
Collaboration, Licensing and Other Arrangements - Schedule of Revenue from Collaborations and Services (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | $ 72,386 | $ 48,611 | $ 138,649 | $ 89,237 |
United Therapeutics Corporation | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 51,570 | 30,230 | 99,032 | 53,257 |
United Therapeutics Corporation | Commercial Supply | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 25,978 | 10,933 | 50,442 | 22,097 |
United Therapeutics Corporation | License Agreement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 242 | 347 | 427 | |
United Therapeutics Corporation | Royalties Arrangement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 25,592 | 19,055 | 48,243 | 30,733 |
Collaborations and services | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 26,014 | 11,211 | 50,862 | 22,597 |
Collaborations and services | License and Distribution Agreement | Cipla Ltd | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 36 | 36 | 73 | 73 |
Collaborations and services | United Therapeutics Corporation | Commercial Supply Agreement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | $ 25,978 | 10,933 | 50,442 | 22,097 |
Collaborations and services | United Therapeutics Corporation | License Agreement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | $ 242 | $ 347 | $ 427 |
Collaboration, Licensing and _4
Collaboration, Licensing and Other Arrangements - Summary of UT Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from UT | $ 72,386 | $ 48,611 | $ 138,649 | $ 89,237 |
United Therapeutics Corporation | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from UT | 51,570 | 30,230 | 99,032 | 53,257 |
United Therapeutics Corporation | Commercial Supply | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from UT | 25,978 | 10,933 | 50,442 | 22,097 |
United Therapeutics Corporation | License Agreement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from UT | 242 | 347 | 427 | |
United Therapeutics Corporation | Royalties Arrangement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from UT | $ 25,592 | $ 19,055 | $ 48,243 | $ 30,733 |
Collaboration, Licensing and _5
Collaboration, Licensing and Other Arrangements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
Oct. 31, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | May 31, 2018 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Feb. 28, 2023 | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue - current | $ 9,085,000 | $ 7,420,000 | $ 7,420,000 | $ 9,085,000 | ||||||||
Deferred revenue - non-current | 69,794,000 | 66,116,000 | 66,116,000 | 69,794,000 | ||||||||
Total revenue from UT | 72,386,000 | $ 48,611,000 | 138,649,000 | $ 89,237,000 | ||||||||
Collaborations and services | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue from UT | 26,014,000 | 11,211,000 | 50,862,000 | 22,597,000 | ||||||||
AFREZZA product sales | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue from UT | 20,780,000 | 18,345,000 | 39,544,000 | 35,907,000 | ||||||||
United Therapeutics Corporation | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue from UT | 51,570,000 | 30,230,000 | 99,032,000 | 53,257,000 | ||||||||
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 | 1,000,000 | |||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total anticipated cash flows | [1] | 722,300,000 | ||||||||||
Deferred revenue | 77,500,000 | 72,300,000 | 72,300,000 | 77,500,000 | ||||||||
Deferred revenue - current | 8,900,000 | 7,300,000 | 7,300,000 | 8,900,000 | ||||||||
Deferred revenue - non-current | $ 68,600,000 | 65,000,000 | $ 65,000,000 | 68,600,000 | ||||||||
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 | |||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Manufacturing Services | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total anticipated cash flows | 722,300,000 | |||||||||||
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 | |||||||||||
Commercial Supply Agreement | United Therapeutics Corporation | Collaborations and services | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total revenue from UT | 25,978,000 | 10,933,000 | $ 50,442,000 | 22,097,000 | ||||||||
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 | 1,200,000 | 1,200,000 | 1,400,000 | ||||||||
Deferred revenue - current | 200,000 | 100,000 | 100,000 | 200,000 | ||||||||
Deferred revenue - non-current | $ 1,200,000 | 1,100,000 | 1,100,000 | $ 1,200,000 | ||||||||
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 | $ 36,000 | $ 36,000 | $ 73,000 | $ 73,000 | ||||||||
[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 Product Sales 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 _6
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] |
[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 Product Sales 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 and Product Sales 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 and Product Sales 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 _7
Collaboration, Licensing and Other Arrangements - Schedule of Revised Anticipated Cash Flows from Transactions Allocated Performance Obligations (Parenthetical) (Details) - United Therapeutics Corporation - Collaboration and License Agreement $ in Millions | 1 Months Ended | |
Dec. 31, 2022 USD ($) | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Total anticipated cash flows | $ 722.3 | [1] |
Manufacturing Services | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Total anticipated cash flows | 722.3 | |
Manufacturing Services and Product Sales | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Allocated transaction price | 220.8 | |
Manufacturing Services and Product Sales | Transaction Price For The Contractual Obligations | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Total anticipated cash flows | 120 | |
Next-Gen R&D Services | Transaction Price For The Performance Obligations | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [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 Product Sales 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 _8
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] | |
Anticipated revenue allocation | $ 2.2 |
Deferred revenue recognition period | 15 years |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Fair Value of Financial Instruments (Detail) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Carrying Amount | MidCap Credit Facility | ||
Financial liabilities: | ||
Total financial liabilities fair value | $ 33 | |
Carrying Amount | Senior Convertible Notes | ||
Financial liabilities: | ||
Total financial liabilities fair value | $ 227.6 | 226.9 |
Carrying Amount | Mann Group Convertible Note | ||
Financial liabilities: | ||
Total financial liabilities fair value | 8.8 | |
Carrying Amount | Milestone Rights | ||
Financial liabilities: | ||
Total financial liabilities fair value | 3.9 | 3.9 |
Carrying Amount | Contingent Milestone Liability | ||
Financial liabilities: | ||
Total financial liabilities fair value | 0.3 | 0.3 |
Carrying Amount | Financing Liability | ||
Financial liabilities: | ||
Total financial liabilities fair value | 104 | 104.1 |
Carrying Amount | Liability for Sale of Future Royalties | ||
Financial liabilities: | ||
Total financial liabilities fair value | 147.5 | |
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | MidCap Credit Facility | ||
Financial liabilities: | ||
Total financial liabilities fair value | 35.5 | |
Estimate of Fair Value Measurement | Senior Convertible Notes | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 258.9 | 231.3 |
Estimate of Fair Value Measurement | Mann Group Convertible Note | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 14.4 | |
Estimate of Fair Value Measurement | Milestone Rights | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 10.6 | 11.9 |
Estimate of Fair Value Measurement | Contingent Milestone Liability | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 0.3 | 0.3 |
Estimate of Fair Value Measurement | Financing Liability | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | 106.6 | $ 106.8 |
Estimate of Fair Value Measurement | Liability for Sale of Future Royalties | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Total financial liabilities fair value | $ 163.9 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Fair Value of Financial Instruments (Parenthetical) (Detail) $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) | |
MidCap Credit Facility | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 12 | |
Note payable, percentage of interest rate increases (decreases) | 2% | |
MidCap Credit Facility | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 35 | |
MidCap Credit Facility | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 36 | |
Mann Group Convertible Notes | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 13 | |
Note payable, percentage of interest rate increases (decreases) | 2% | |
Mann Group Convertible Notes | Volatility | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 62.7 | |
Mann Group Convertible Notes | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 14.2 | |
Mann Group Convertible Notes | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 14.7 | |
Senior Convertible Notes | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 11 | 11 |
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 | 53 | 62.7 |
Senior Convertible Notes | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 253 | $ 224.1 |
Senior Convertible Notes | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 265 | $ 238.9 |
Financing Liability | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 9.5 | 9.5 |
Note payable, percentage of interest rate increases (decreases) | 2% | |
Financing Liability | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 94 | |
Financing Liability | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 122.1 | |
Milestone Rights | Risk-Free Rate | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 4.3 | 3.9 |
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 | 7.5 | 8 |
Milestone Rights | Credit Risk | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 15 | 17 |
Contingent Milestone Liability | Risk-Free Rate | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 4.5 | 4 |
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 | 60 | 43 |
Contingent Milestone Liability | Period | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 13.5 | 15 |
Contingent Milestone Liability | Credit Risk | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, fair value key inputs | 15 | 17 |
Liability for Sale of Future Royalties | ||
Fair Value Of Financial Instruments [Line Items] | ||
Note payable, percentage of hypothetical yield | 11 | |
Note payable, percentage of interest rate increases (decreases) | 2% | |
Liability for Sale of Future Royalties | Minimum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 144.1 | |
Liability for Sale of Future Royalties | Maximum | ||
Fair Value Of Financial Instruments [Line Items] | ||
Financial liabilities fair value | $ 188.3 |
Common and Preferred Stock - Ad
Common and Preferred Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Feb. 28, 2018 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Class of Stock [Line Items] | |||||||
Common stock, shares authorized | 800,000,000 | 800,000,000 | |||||
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 | 274,467,247 | 270,034,495 | |||||
Common stock, shares outstanding | 274,467,247 | 270,034,495 | |||||
Undesignated preferred stock, shares outstanding | 0 | 0 | |||||
Proceeds from market price stock purchase plan | $ 1.4 | $ 0.2 | |||||
Market price stock purchase plan | 416,099 | 36,004 | |||||
Common Stock | |||||||
Class of Stock [Line Items] | |||||||
Number of shares sold during the period | 416,000 | 362,000 | 269,000 | ||||
Controlled 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 | $ 2.8 | ||||||
Number of shares sold during the period | 631,383 | ||||||
At Market Issuance Sales Agreement | Cantor Fitzgerald | Common Stock | Weighted Average | |||||||
Class of Stock [Line Items] | |||||||
Exchange price per share | $ 4.4 | $ 4.4 |
Earnings Per Common Share - Com
Earnings Per Common Share - Components of Basic and Diluted EPS Computations (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
EPS - basic: | ||||||
Net Income (Loss) | $ (2,014) | $ 10,630 | $ (5,265) | $ (9,795) | $ 8,616 | $ (15,060) |
Weighted average common shares (denominator), Basic | 273,056 | 265,626 | 271,706 | 264,802 | ||
Net income (loss) per share - basic | $ (0.01) | $ (0.02) | $ 0.03 | $ (0.06) | ||
EPS - diluted: | ||||||
Net income (loss) - basic | $ (2,014) | $ (5,265) | $ 8,616 | $ (15,060) | ||
Weighted average common shares | 273,056 | 265,626 | 271,706 | 264,802 | ||
Effect of dilutive securities - common shares issuable | 7,652 | |||||
Adjusted weighted average common shares (denominator) | 273,056 | 265,626 | 279,358 | 264,802 | ||
Net income (loss) per share - diluted | $ (0.01) | $ (0.02) | $ 0.03 | $ (0.06) |
Earnings Per Common Share - Pot
Earnings Per Common Share - Potential Dilutive Securities Outstanding that are Considered Antidilutive (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of earnings per share | 68,791,473 | 73,130,822 | 73,130,822 | |
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 | 44,100,000 | 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 | 16,750,557 | 16,951,734 | 7,800,000 | 16,951,734 |
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 | 7,920,453 | 8,688,625 | 1,900,000 | 8,688,625 |
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 |
Earnings Per Common Share - P_2
Earnings Per Common Share - 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 | 100% | 178% | 194% |
Stock-Based Compensation Expe_3
Stock-Based Compensation Expense - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Issuance of common stock under the employee stock purchase plan | $ 959,000 | $ 923,000 | ||
Common Stock | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Issuance of common stock under the employee stock purchase plan | $ 3,000 | $ 3,000 | ||
Issuance of common stock under the employee stock purchase plan (in shares) | 310,000 | 266,000 | ||
ESPP | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock available for issuance | 2,600,000 | 2,600,000 | ||
Employees Awards | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Issuance of common stock under the employee stock purchase plan | $ 25,000 | |||
Issuance of common stock under the employee stock purchase plan (in shares) | 5,000 | |||
Employees Awards | ESPP | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Discount on purchase price percentage of fair market value | 85% | |||
RSUs | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Restricted stock units weighted average grant date fair value | $ 4.45 | $ 3.28 | ||
Restricted stock units grant date fair value | 3,033,680 | 211,895 | ||
Unrecognized compensation expense, weighted average period for recognition | 2 years 10 months 2 days | |||
Unrecognized compensation expense related to non-option | $ 28,200,000 | $ 28,200,000 | ||
RSUs | Share-Based Payment Arrangement, Tranche One | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 4 years | 3 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25% | 33.30% | ||
RSUs | Share-Based Payment Arrangement, Tranche Two | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 2 years | 4 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.30% | 33.30% | ||
RSUs | Share-Based Payment Arrangement, Tranche Three | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.30% | 33.30% | ||
RSUs | Employees Awards | Share-Based Payment Arrangement, Tranche One | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 2 years | 2 years | ||
Restricted stock units grant date fair value | 145,980 | 53,720 | ||
RSUs | Employees Awards | Share-Based Payment Arrangement, Tranche Two | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 3 years | 3 years | ||
Restricted stock units grant date fair value | 26,250 | 2,375 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25% | |||
RSUs | Employees Awards | Share-Based Payment Arrangement, Tranche Three | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period | 4 years | 4 years | ||
Market RSU's | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Restricted stock units weighted average grant date fair value | $ 10.3 | |||
Unrecognized compensation expense, weighted average period for recognition | 2 years 2 months 19 days | |||
Unrecognized compensation expense related to non-option | $ 31,400,000 | $ 31,400,000 | ||
Market RSU's | Employees Awards | Share-Based Payment Arrangement, Tranche One | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 0% | |||
Market RSU's | Employees Awards | Share-Based Payment Arrangement, Tranche Two | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 50% | |||
Market RSU's | Employees Awards | Share-Based Payment Arrangement, Tranche Three | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 100% |
Stock-Based Compensation Expe_4
Stock-Based Compensation Expense - Schedule of Employee Awards and Non-employee Director Award Plan Activity (Details) - shares | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2024 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 5,630,286 | 267,990 | 5,898,276 |
Employees Awards | RSUs | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 3,205,910 | 267,990 | 3,473,900 |
Employees Awards | Market RSUs | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 2,144,000 | 2,144,000 | |
Non-employee Directors Awards | RSUs | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 280,376 | 280,376 |
Stock-Based Compensation Expe_5
Stock-Based Compensation Expense - Schedule of Employee Awards and Non-employee Director Award Plan Activity (Parenthetical) (Details) - $ / shares | 3 Months Ended | |
Jun. 30, 2024 | Mar. 31, 2024 | |
RSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units weighted average grant date fair value | $ 4.45 | $ 3.28 |
Restricted stock units grant date fair value | 3,033,680 | 211,895 |
RSUs | Share-Based Payment Arrangement, Tranche One | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25% | 33.30% |
Vesting period | 4 years | 3 years |
RSUs | Share-Based Payment Arrangement, Tranche Two | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.30% | 33.30% |
Vesting period | 2 years | 4 years |
RSUs | Share-Based Payment Arrangement, Tranche Three | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.30% | 33.30% |
RSUs | Share-Based Payment Arrangement, Tranche Four | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.30% | |
Market RSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units weighted average grant date fair value | $ 10.3 | |
Employees Awards | RSUs | Share-Based Payment Arrangement, Tranche One | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units grant date fair value | 145,980 | 53,720 |
Vesting period | 2 years | 2 years |
Employees Awards | RSUs | Share-Based Payment Arrangement, Tranche Two | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units grant date fair value | 26,250 | 2,375 |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25% | |
Vesting period | 3 years | 3 years |
Employees Awards | RSUs | Share-Based Payment Arrangement, Tranche Three | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Vesting period | 4 years | 4 years |
Employees Awards | Market RSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Vesting date | Jul. 15, 2027 | |
Employees Awards | Market RSUs | Share-Based Payment Arrangement, Tranche One | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 0% | |
Employees Awards | Market RSUs | Share-Based Payment Arrangement, Tranche Two | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 50% | |
Employees Awards | Market RSUs | Share-Based Payment Arrangement, Tranche Three | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 100% | |
Employees Awards | Market RSUs | Share-Based Payment Arrangement, Tranche Four | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 200% | |
Employees Awards | Market RSUs | Index Target 90th Percentile or Higher | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 300% | |
Non-employee Directors Awards | RSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units weighted average grant date fair value | $ 4.45 |
Stock-Based Compensation Expe_6
Stock-Based Compensation Expense - Stock Based Compensation Expense Recognized in Condensed Consolidated Statements of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | $ 6,428 | $ 5,580 | $ 10,313 | $ 9,235 |
RSUs and Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | 6,248 | 5,404 | 9,947 | 8,882 |
Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | $ 180 | $ 176 | $ 366 | $ 353 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2023 USD ($) ConsecutiveMonth | Feb. 28, 2023 USD ($) | Jun. 30, 2022 USD ($) | Nov. 30, 2021 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | Jun. 30, 2024 EUR (€) | Jul. 01, 2013 USD ($) | ||
Commitments And Contingencies [Line Items] | ||||||||||||
Operating lease costs | $ 350,000 | $ 410,000 | $ 698,000 | $ 831,000 | ||||||||
Financing Liability | $ 104,100,000 | 104,000,000 | 104,000,000 | $ 104,100,000 | ||||||||
Financing liability - long term | 94,319,000 | 94,094,000 | 94,094,000 | 94,319,000 | ||||||||
Financing liability - current | 9,809,000 | 9,935,000 | $ 9,935,000 | 9,809,000 | ||||||||
Supply Agreement expiration period | Dec. 31, 2034 | |||||||||||
Supply Agreement renewal period | 2 years | |||||||||||
Milestone liabilities | 3,452,000 | 2,813,000 | $ 2,813,000 | 3,452,000 | ||||||||
Milestone liabilities remeasurement amount | 4,200,000 | |||||||||||
Returns reserve for acquired product | [1] | 601,000 | 1,290,000 | 1,290,000 | 601,000 | |||||||
Losses on estimated returns of acquired product | 1,400,000 | |||||||||||
Loss on purchase commitments | € | € 56.6 | |||||||||||
Insulin | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Loss on purchase commitments | $ 64,800,000 | 60,200,000 | 60,200,000 | 64,800,000 | ||||||||
Tyvaso DPI | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Royalty commencement date | Oct. 01, 2023 | |||||||||||
Royalty termination date | Dec. 31, 2042 | |||||||||||
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 | |||||||||||
Lease initial term | 20 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. | |||||||||||
Accrued Expenses And Other Current Liabilities | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Returns reserve for acquired product | 1,300,000 | 1,300,000 | ||||||||||
General and Administrative Expense | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Losses on estimated returns of acquired product | 300,000 | $ 1,400,000 | ||||||||||
Maximum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Effective interest rate | 11.50% | |||||||||||
Minimum | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Effective interest rate | 11.10% | |||||||||||
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 remain payable | $ 55,000,000 | |||||||||||
Remaining milestone rights liability | $ 3,900,000 | 3,900,000 | $ 3,900,000 | 3,900,000 | ||||||||
Milestone rights liability, current | 800,000 | 1,400,000 | 1,400,000 | 800,000 | ||||||||
Milestone liabilities | 3,100,000 | $ 2,500,000 | $ 2,500,000 | 3,100,000 | ||||||||
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% | |||||||||||
Description of right to extension of lease term | The Company has no further right to extend the lease term beyond July 31, 2028. | |||||||||||
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% | |||||||||||
Unamortized transaction costs | $ 4,300,000 | $ 4,400,000 | ||||||||||
Sagard | Tyvaso DPI | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Purchase price | $ 200,000,000 | |||||||||||
Sagard | Net Sales Threshold A | Tyvaso DPI | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payment | 50,000,000 | |||||||||||
Net sales | 1,900,000,000 | |||||||||||
Sagard | Net Sales Threshold B | Tyvaso DPI | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Milestone payment | 45,000,000 | |||||||||||
Net sales | $ 2,300,000,000 | |||||||||||
Number of consecutive months | ConsecutiveMonth | 12 | |||||||||||
Sagard | Net Sales Thresholds A and B | Tyvaso DPI | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Net sales | $ 3,500,000,000 | |||||||||||
Sagard | Remainder of Year | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Royalties | $ 0 | |||||||||||
Sagard | Royalty Liability | ||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||
Royalty rights | 1% | |||||||||||
Transaction costs | $ 4,400,000 | |||||||||||
Percentage of Future Royalty Revenues | 10% | |||||||||||
[1] See Note 14 – Commitments and Contingencies under Loss Contingencies — Returns Reserve for Acquired Product . |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule Of Royalty Liability Account Roll Forward (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2024 | Jun. 30, 2024 | |
Commitments And Contingencies [Line Items] | ||
Balance, beginning of period | $ 721,366 | |
Non-cash interest expense on liability for sale of future royalties | $ 4,383 | 8,631 |
Balance, end of period | 669,616 | $ 669,616 |
Minimum | ||
Commitments And Contingencies [Line Items] | ||
Effective interest rate | 11.10% | |
Maximum | ||
Commitments And Contingencies [Line Items] | ||
Effective interest rate | 11.50% | |
Royalty Liability | ||
Commitments And Contingencies [Line Items] | ||
Balance, beginning of period | $ 145,810 | |
Amortization of deferred transaction costs | 114 | |
Non-cash interest expense on liability for sale of future royalties | 8,517 | |
Royalty revenue earned by or payable to Sagard | (6,927) | |
Balance, end of period | $ 147,514 | $ 147,514 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Financing Liability Lease Term and Discount Rate (Detail) | Jun. 30, 2024 | Dec. 31, 2023 |
Commitments And Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term (in years) | 17 years 3 months 18 days | 17 years 9 months 18 days |
Weighted average discount rate | 9% | 9% |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Financing Liability Costs (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Commitments And Contingencies Disclosure [Abstract] | ||||
Interest expense on financing liability | $ 2,444 | $ 2,449 | $ 4,891 | $ 4,873 |
Commitments and Contingencies_5
Commitments and Contingencies - Schedule of Remaining Financing Liability Payments (Detail) $ in Thousands | Jun. 30, 2024 USD ($) |
Operating Lease Liabilities Payments Due [Abstract] | |
Remainder of 2024 | $ 5,027 |
2025 | 10,269 |
2026 | 10,533 |
2027 | 10,849 |
2028 | 11,174 |
Thereafter | 177,278 |
Total | 225,130 |
Interest payments | (118,530) |
Debt issuance costs | (2,571) |
Total financing liability | $ 104,029 |
Commitments and Contingencies_6
Commitments and Contingencies - Summary of Finance Lease Information (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Financing lease right-of-use asset | $ 222 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other Assets Noncurrent |
Financing lease liability-current | $ 39 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities Current |
Financing lease liability-long-term | $ 184 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Financing lease liability-long-term |
Total | $ 223 |
Weighted average remaining lease term (in years) | 4 years 10 months 24 days |
Weighted average discount rate | 7.30% |
Commitment and contingencies -
Commitment and contingencies - Schedule of Remaining Financing Lease Payments (Detail) $ in Thousands | Jun. 30, 2024 USD ($) |
Commitments And Contingencies [Line Items] | |
Remainder of 2024 | $ 5,027 |
2025 | 10,269 |
2026 | 10,533 |
2027 | 10,849 |
2028 | 11,174 |
Thereafter | 177,278 |
Total | 225,130 |
Interest payments | (118,530) |
Total financing liability | 104,029 |
Audio Visual Equipment | |
Commitments And Contingencies [Line Items] | |
Remainder of 2024 | 27 |
2025 | 54 |
2026 | 54 |
2027 | 54 |
2028 | 54 |
Thereafter | 23 |
Total | 266 |
Interest payments | (43) |
Total financing liability | $ 223 |
Commitments and Contingencies_7
Commitments and Contingencies - Remaining Purchase Commitments and Estimated Capacity Fee Liability Requirements (Detail) € in Millions | Jun. 30, 2024 EUR (€) |
Purchase Obligation Fiscal Year Maturity [Abstract] | |
Remaining Purchase Commitments, 2026 | € 4.2 |
Remaining Purchase Commitments, 2027 | 6 |
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 | 56.6 |
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_8
Commitments and Contingencies - Remaining Purchase Commitments and Estimated Capacity Fee Liability Requirements (Parenthetical) (Details) | Jun. 30, 2024 EUR (€) |
Purchase Obligation Fiscal Year Maturity [Abstract] | |
Capacity fee | € 750,000 |
Commitments and Contingencies_9
Commitments and Contingencies - Schedule of Lease Term and Discount Rate (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Commitments And Contingencies Disclosure [Abstract] | ||
Operating lease, right-of-use asset | $ 4,073 | $ 4,685 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other assets | Other assets |
Operating lease liability-current | $ 1,773 | $ 1,423 |
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 | $ 3,272 | $ 3,925 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Operating lease liability | Operating lease liability |
Total | $ 5,045 | $ 5,348 |
Weighted average remaining lease term (in years) | 3 years 4 months 24 days | 3 years 8 months 12 days |
Incremental borrowing rate | 7.30% | 7.30% |
Commitments and Contingencie_10
Commitments and Contingencies - Summary of Lease Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Commitments And Contingencies Disclosure [Abstract] | ||||
Operating lease costs | $ 350 | $ 410 | $ 698 | $ 831 |
Variable lease costs | 9 | 13 | 19 | 49 |
Cash paid | $ 314 | $ 234 | $ 546 | $ 557 |
Commitments and Contingencie_11
Commitments and Contingencies - Schedule of Future Minimum Office And Vehicle Lease Payments (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Commitments And Contingencies [Line Items] | ||
Operating lease, liability | $ 5,045 | $ 5,348 |
office and vehicle | ||
Commitments And Contingencies [Line Items] | ||
Remainder of 2024 | 918 | |
Year 1 | 1,829 | |
Year 2 | 1,213 | |
Year 3 | 1,135 | |
Year 4 | 643 | |
Total | 5,738 | |
Interest expense | (693) | |
Operating lease, liability | $ 5,045 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | |
Operating Loss Carryforwards [Line Items] | |||
Income tax expense | $ 323,000 | $ 587,000 | |
Effective tax rate (as a percent) | 21% | ||
Unrecognized income tax interest and penalties | $ 0 | ||
California | Senate Bills 167 | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating losses | $ 5,000,000 | $ 5,000,000 | $ 5,000,000 |
Tax years | 2024 2025 2026 | ||
California | Senate Bills 175 | |||
Operating Loss Carryforwards [Line Items] | |||
Tax years | 2025 2026 |
Subsequent Events (Additional I
Subsequent Events (Additional Information) (Details) $ in Millions | 1 Months Ended | |
May 28, 2024 Employees | Jun. 30, 2024 USD ($) | |
Subsequent Event [Line Items] | ||
Letters of credit secured by cash held in restricted depository account | $ 0.7 | |
Number of pulmatrix employees which began employment | Employees | 13 | |
Lease term extension period | Effective Date through November 30, 2033 | |
Lease monthly payments | $ 0.1 | |
Percentage of annual increment on lease | 3% |