Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 30, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
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 | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity File Number | 000-50865 | |
Entity Tax Identification Number | 13-3607736 | |
Entity Address, Address Line One | 30930 Russell Ranch Road | |
Entity Address, Address Line Two | Suite 300 | |
Entity Address, City or Town | Westlake Village | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 91362 | |
City Area Code | 818 | |
Local Phone Number | 661-5000 | |
Entity Common Stock, Shares Outstanding | 249,660,178 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 62,522 | $ 67,005 |
Restricted cash | 158 | |
Short-term investments | 99,970 | |
Accounts receivable, net | 6,305 | 4,218 |
Inventory | 7,482 | 4,973 |
Prepaid expenses and other current assets | 3,624 | 3,122 |
Total current assets | 179,903 | 79,476 |
Property and equipment, net | 28,139 | 25,867 |
Long-term investments | 38,950 | |
Other assets | 5,799 | 3,265 |
Total assets | 252,791 | 108,608 |
Current liabilities: | ||
Accounts payable | 7,486 | 5,582 |
Accrued expenses and other current liabilities | 22,406 | 19,707 |
PPP loan — current | 4,873 | 4,061 |
Deferred revenue — current | 20,126 | 33,275 |
Recognized loss on purchase commitments — current | 5,538 | 11,080 |
Total current liabilities | 60,429 | 73,705 |
Senior convertible notes | 223,217 | |
MidCap credit facility | 38,614 | 49,335 |
Mann Group promissory notes | 18,425 | 63,027 |
Accrued interest — Mann Group promissory notes | 169 | 4,150 |
PPP loan — long term | 812 | |
2024 convertible notes | 5,000 | |
Recognized loss on purchase commitments — long term | 83,179 | 84,208 |
Operating lease liability | 564 | 1,202 |
Deferred revenue — long term | 1,589 | 1,662 |
Milestone rights liability | 4,839 | 5,926 |
Deposits from customer | 5,317 | |
Total liabilities | 436,342 | 289,027 |
Commitments and contingencies (Note 12) | ||
Stockholders' deficit: | ||
Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2021 and December 31, 2020 | ||
Common stock, $0.01 par value - 400,000,000 shares authorized, 249,617,550 and 242,117,089 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 2,496 | 2,421 |
Additional paid-in capital | 2,911,535 | 2,866,303 |
Accumulated deficit | (3,097,582) | (3,049,143) |
Total stockholders' deficit | (183,551) | (180,419) |
Total liabilities and stockholders' deficit | $ 252,791 | $ 108,608 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
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 | 400,000,000 | 400,000,000 |
Common stock, shares issued | 249,617,550 | 242,117,089 |
Common stock, shares outstanding | 249,617,550 | 242,117,089 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 23,280 | $ 15,114 | $ 40,716 | $ 31,349 |
Expenses: | ||||
Cost of goods sold | 4,411 | 3,677 | 8,726 | 7,841 |
Research and development | 2,329 | 1,464 | 4,771 | 3,219 |
Selling, general and administrative | 20,056 | 13,670 | 37,469 | 28,020 |
Asset impairment | 368 | 1,889 | ||
Loss (gain) on foreign currency translation | 903 | 1,867 | (2,935) | 71 |
Loss on purchase commitments | 339 | 339 | ||
Total expenses | 33,553 | 23,029 | 57,180 | 46,385 |
Loss from operations | (10,273) | (7,915) | (16,464) | (15,036) |
Other (expense) income: | ||||
Interest income | 25 | 14 | 28 | 147 |
Interest expense on notes | (2,812) | (1,084) | (8,234) | (2,155) |
Interest expense on Mann Group promissory notes | (368) | (1,281) | (1,398) | (2,540) |
Loss on extinguishment of debt | (22,130) | (22,130) | ||
Other income (expense) | 35 | 14 | (241) | 10 |
Total other expense | (25,250) | (2,337) | (31,975) | (4,538) |
Loss before provision for income taxes | (35,523) | (10,252) | (48,439) | (19,574) |
Net loss | $ (35,523) | $ (10,252) | $ (48,439) | $ (19,574) |
Net loss per share - basic and diluted | $ (0.14) | $ (0.05) | $ (0.20) | $ (0.09) |
Shares used to compute basic and diluted net loss per share | 249,295 | 213,880 | 247,970 | 212,943 |
Commercial product sales | ||||
Revenues: | ||||
Total revenues | $ 9,976 | $ 6,985 | $ 18,075 | $ 14,985 |
Collaborations and services | ||||
Revenues: | ||||
Total revenues | 13,304 | 8,129 | 22,641 | 16,364 |
Expenses: | ||||
Cost of revenue | $ 5,515 | $ 1,983 | $ 8,810 | $ 5,345 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (35,523) | $ (10,252) | $ (48,439) | $ (19,574) |
Other comprehensive loss: | ||||
Cumulative translation loss | (19) | |||
Comprehensive loss | $ (35,523) | $ (10,252) | $ (48,439) | $ (19,593) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Total | Convertible NoteMann Group | June 2020 Note | Convertible Note InterestMann Group | 2024 Convertible Notes | 2024 Convertible Note Interest | At-the-market Offering | Common Stock | Common StockConvertible NoteMann Group | Common StockJune 2020 Note | Common StockConvertible Note InterestMann Group | Common Stock2024 Convertible Notes | Common Stock2024 Convertible Note Interest | Common StockAt-the-market Offering | Additional Paid-in Capital | Additional Paid-in CapitalConvertible NoteMann Group | Additional Paid-in CapitalJune 2020 Note | Additional Paid-in CapitalConvertible Note InterestMann Group | Additional Paid-in Capital2024 Convertible Notes | Additional Paid-in Capital2024 Convertible Note Interest | Additional Paid-in CapitalAt-the-market Offering | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2019 | $ (190,526) | $ 2,118 | $ 2,799,278 | $ (19) | $ (2,991,903) | ||||||||||||||||||
Beginning Balance (in shares) at Dec. 31, 2019 | 211,788,000 | ||||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units | (317) | $ 5 | (322) | ||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 504,000 | ||||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 318 | $ 3 | 315 | ||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 334,000 | ||||||||||||||||||||||
Stock-based compensation expense | 1,128 | 1,128 | |||||||||||||||||||||
Issuance of common stock associated with debt interest payment | 144 | $ 1 | 143 | ||||||||||||||||||||
Issuance of common stock associated with debt interest payment (in shares) | 99,000 | ||||||||||||||||||||||
Issuance of common stock | $ 522 | $ 4 | $ 518 | ||||||||||||||||||||
Issuance of common stock (in shares) | 413,000 | ||||||||||||||||||||||
Issuance cost associated with at-the-market offering | (16) | (16) | |||||||||||||||||||||
Write-off of cumulative translation loss | 19 | 19 | |||||||||||||||||||||
Net loss | (9,322) | (9,322) | |||||||||||||||||||||
Ending Balance at Mar. 31, 2020 | (198,050) | $ 2,131 | 2,801,044 | (3,001,225) | |||||||||||||||||||
Ending Balance (in shares) at Mar. 31, 2020 | 213,138,000 | ||||||||||||||||||||||
Beginning Balance at Dec. 31, 2019 | (190,526) | $ 2,118 | 2,799,278 | $ (19) | (2,991,903) | ||||||||||||||||||
Beginning Balance (in shares) at Dec. 31, 2019 | 211,788,000 | ||||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 333,727 | ||||||||||||||||||||||
Net loss | (19,574) | ||||||||||||||||||||||
Ending Balance at Jun. 30, 2020 | (179,710) | $ 2,289 | 2,829,478 | (3,011,477) | |||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2020 | 228,928,000 | ||||||||||||||||||||||
Beginning Balance at Mar. 31, 2020 | (198,050) | $ 2,131 | 2,801,044 | (3,001,225) | |||||||||||||||||||
Beginning Balance (in shares) at Mar. 31, 2020 | 213,138,000 | ||||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units | 117 | $ 3 | 114 | ||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 297,000 | ||||||||||||||||||||||
Stock-based compensation expense | 2,185 | 2,185 | |||||||||||||||||||||
Issuance of common stock from the exercise of warrants | 11,600 | $ 73 | 11,527 | ||||||||||||||||||||
Issuance of common stock from the exercise of warrants (in Share) | 7,250,000 | ||||||||||||||||||||||
Issuance of common stock pursuant to conversion notes | $ 2,630 | $ 12 | $ 2,618 | ||||||||||||||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 1,235,000 | ||||||||||||||||||||||
Issuance of common stock | 12,366 | $ 75 | 12,291 | ||||||||||||||||||||
Issuance of common stock (in shares) | 7,459,000 | ||||||||||||||||||||||
Issuance cost associated with at-the-market offering | (320) | (320) | |||||||||||||||||||||
Issuance of common stock from market price stock purchase | 14 | 14 | |||||||||||||||||||||
Issuance of common stock under Market Price Stock Purchase Plan (in shares) | 10,000 | ||||||||||||||||||||||
Adjustment of common stock in association with restricted stock units | $ (5) | 5 | |||||||||||||||||||||
Adjustment of common stock in association with restricted stock units (in shares) | (461,000) | ||||||||||||||||||||||
Net loss | (10,252) | (10,252) | |||||||||||||||||||||
Ending Balance at Jun. 30, 2020 | (179,710) | $ 2,289 | 2,829,478 | (3,011,477) | |||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2020 | 228,928,000 | ||||||||||||||||||||||
Beginning Balance at Dec. 31, 2020 | (180,419) | $ 2,421 | 2,866,303 | (3,049,143) | |||||||||||||||||||
Beginning Balance (in shares) at Dec. 31, 2020 | 242,118,000 | ||||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units | 397 | $ 4 | 393 | ||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 390,000 | ||||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 390 | $ 3 | 387 | ||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 293,000 | ||||||||||||||||||||||
Stock-based compensation expense | 1,935 | 1,935 | |||||||||||||||||||||
Issuance of common stock pursuant to conversion notes | $ 9,573 | $ 427 | $ 5,000 | $ 38 | $ 2 | $ 17 | $ 9,535 | $ 425 | $ 4,983 | ||||||||||||||
Issuance of common stock pursuant to conversion notes (in shares) | 3,830,000 | 170,000 | 1,667,000 | ||||||||||||||||||||
Issuance of common stock pursuant to payoff of the 2024 convertible note interest | $ 143 | $ 143 | |||||||||||||||||||||
Issuance of common stock pursuant to payoff of the 2024 convertible note interest (in shares) | 27,000 | ||||||||||||||||||||||
Issuance of common stock | $ 1,886 | $ 6 | $ 1,880 | ||||||||||||||||||||
Issuance of common stock (in shares) | 578,000 | ||||||||||||||||||||||
Issuance cost associated with at-the-market offering | (38) | (38) | |||||||||||||||||||||
Net loss | (12,916) | (12,916) | |||||||||||||||||||||
Ending Balance at Mar. 31, 2021 | (173,622) | $ 2,491 | 2,885,946 | (3,062,059) | |||||||||||||||||||
Ending Balance (in shares) at Mar. 31, 2021 | 249,073,000 | ||||||||||||||||||||||
Beginning Balance at Dec. 31, 2020 | (180,419) | $ 2,421 | 2,866,303 | (3,049,143) | |||||||||||||||||||
Beginning Balance (in shares) at Dec. 31, 2020 | 242,118,000 | ||||||||||||||||||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 292,981 | ||||||||||||||||||||||
Net loss | (48,439) | ||||||||||||||||||||||
Ending Balance at Jun. 30, 2021 | (183,551) | $ 2,496 | 2,911,535 | (3,097,582) | |||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2021 | 249,618,000 | ||||||||||||||||||||||
Beginning Balance at Mar. 31, 2021 | (173,622) | $ 2,491 | 2,885,946 | (3,062,059) | |||||||||||||||||||
Beginning Balance (in shares) at Mar. 31, 2021 | 249,073,000 | ||||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units | (545) | $ 5 | (550) | ||||||||||||||||||||
Net issuance of common stock associated with stock options and restricted stock units (in shares) | 520,000 | ||||||||||||||||||||||
Stock-based compensation expense | 3,926 | 3,926 | |||||||||||||||||||||
Premium on Mann Group convertible note | 22,107 | 22,107 | |||||||||||||||||||||
Issuance of common stock from market price stock purchase | 106 | 106 | |||||||||||||||||||||
Issuance of common stock under Market Price Stock Purchase Plan (in shares) | 25,000 | ||||||||||||||||||||||
Net loss | (35,523) | (35,523) | |||||||||||||||||||||
Ending Balance at Jun. 30, 2021 | $ (183,551) | $ 2,496 | $ 2,911,535 | $ (3,097,582) | |||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2021 | 249,618,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (48,439,000) | $ (19,574,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Loss on extinguishment of debt | 22,130,000 | |
Stock-based compensation expense | 5,861,000 | 3,313,000 |
Interest on milestone payment | 3,663,000 | |
Loss (gain) on foreign currency translation | (2,935,000) | 71,000 |
Depreciation, amortization and accretion | 1,671,000 | 1,105,000 |
Interest expense on Mann Group promissory notes | 1,398,000 | 2,536,000 |
Amortization of right-of-use assets | 668,000 | 576,000 |
Asset impairment | 1,889,000 | |
Write-off of inventory | 0 | 496,000 |
Other, net | 19,000 | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (2,087,000) | 147,000 |
Inventory | (2,509,000) | (164,000) |
Prepaid expenses and other current assets | (502,000) | 1,352,000 |
Other assets | (202,000) | 82,000 |
Accounts payable | 1,904,000 | 1,032,000 |
Accrued expenses and other current liabilities | 3,215,000 | (1,343,000) |
Deferred revenue | (13,222,000) | (3,803,000) |
Operating lease liabilities | (1,554,000) | (1,401,000) |
Recognized loss on purchase commitments | (3,636,000) | (1,236,000) |
Deposits from customer | 5,317,000 | |
Accrued interest on Mann Group promissory notes | (4,919,000) | |
Net cash used in operating activities | (34,178,000) | (14,903,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of debt securities | (138,920,000) | |
Purchase of available-for-sale securities | (3,000,000) | |
Purchase of property and equipment | (2,030,000) | (300,000) |
Proceeds from sale of treasury bills | 20,000,000 | |
Net cash (used in) provided by investing activities | (143,950,000) | 19,700,000 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the Senior convertible notes | 230,000,000 | |
Issuance costs associated with Senior convertible notes | (7,268,000) | |
Principal payments on Mann Group promissory notes | (35,051,000) | |
Payment of MidCap credit facility | (10,000,000) | |
Payment of MidCap credit facility prepayment penalty | (1,000,000) | |
Milestone payment | 5,000,000 | |
Payment of employment taxes related to vested restricted stock units and exercise of stock options | (148,000) | (201,000) |
Proceeds from market price stock purchase | 106,000 | 14,000 |
Issuance of common stock from the exercise of warrants | 11,600,000 | |
Proceeds from PPP loan | 4,873,000 | |
Net cash provided by financing activities | 173,487,000 | 28,519,000 |
NET INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (4,641,000) | 33,316,000 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 67,163,000 | 30,222,000 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | 62,522,000 | 63,538,000 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | ||
Interest paid in cash, net of amounts capitalized | 6,717,000 | 1,820,000 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Non-cash construction in progress and property and equipment | 1,183,000 | |
Payment of interest through common stock issuance | 143,000 | 144,000 |
Issuance of common stock under Employee Stock Purchase Plan | 390,000 | 318,000 |
Payment of principal on Senior convertible notes through issuance of common stock | 2,630,000 | |
Receivable from at-the-market offering | 470,000 | |
2024 Convertible Notes | ||
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Payment of 2024 convertible notes through issuance of common stock | 5,000,000 | |
Mann Group | ||
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Premium on convertible note | 22,107,000 | |
Payment of convertible notes through common stock issuance | 9,573,000 | |
Payment of interest through common stock issuance | 427,000 | |
At The Market Issuance | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from at-the-market offering | 1,886,000 | 12,564,000 |
Issuance costs associated with at-the-market offering | $ (38,000) | $ (331,000) |
Description of Business and Sig
Description of Business and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
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, 2020 filed with the SEC on February 25, 2021 (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, 2021 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 accompanying 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 and the COVID-19 pandemic has increased the level of judgment used by management in developing these estimates and assumptions. The COVID-19 pandemic continues to rapidly evolve and the ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. 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 and gross-to-net adjustments, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitment, milestone rights liability, stock-based compensation and the determination of the provision for income taxes and corresponding deferred tax assets and liabilities, and the valuation allowance recorded against net deferred tax assets. Business — MannKind is a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. The Company’s lead product is Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, which was approved by the U.S. Food and Drug Administration (“FDA”) in June 2014. Since September 2018, the Company has been collaborating with United Therapeutics to develop an inhaled formulation of treprostinil, known as Tyvaso DPI. In April 2021, United Therapeutics submitted a new drug application (“NDA”) to the FDA seeking approval of Tyvaso DPI. Basis of Presentation — The condensed consolidated financial statements have been prepared in accordance with GAAP. The Company is not currently profitable and has rarely generated positive net cash flow from operations. In addition, the Company expects to continue to incur significant expenditures for the foreseeable future in support of its manufacturing operations, sales and marketing costs for Afrezza, and development of other product candidates in the Company’s pipeline. As of June 30, 2021, the Company had capital resources of $62.5 million in cash and cash equivalents, $100.0 million in short-term investments, $39.0 million in long-term investments, an accumulated deficit of $3.1 billion and total principal amount of outstanding borrowings of $293.3 million. In August 2019, the Company and its wholly owned subsidiary, MannKind LLC, entered into a credit and security agreement with MidCap Financial Trust (as amended, the “MidCap credit facility”). The MidCap Credit Facility currently provides a secured term loan facility with a potential aggregate principal amount of up to $110.0 million, leaving a balance of $50.0 million outstanding as of December 31, 2020. In April 2021, $10.0 million of the outstanding principal amount was repaid leaving a balance of $40.0 million at June 30, 2021. See Note 6 – Borrowings The Company believes its resources will be sufficient to fund its operations for the next twelve months from the date of issuance of these condensed consolidated financial statements. Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported condensed consolidated balance sheets or statements of operations. An adjustment has been made to the condensed consolidated statements of cash flows for the six months ended June 30, 2020 to combine payment of employment taxes related to vested restricted stock units and exercise of stock options in the cash flows from financing activities. These changes in classification do not affect previously reported cash flows from operating or investing activities. 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. 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. 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”) Revenue from Contracts with Customers , At contract inception, once the contract is determined to be within the scope of Topic 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 and specialty pharmacies and (ii) collaboration arrangements. Revenue Recognition – Net Revenue – Commercial Product Sales – The Company sells Afrezza to a limited number of wholesale distributors and specialty pharmacies 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 pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at delivery for wholesale distributors and generally at delivery for specialty pharmacies. Product revenues are recorded net of applicable reserves, including discounts, allowances, rebates, returns and other incentives. See Reserves for Variable Consideration below. Free Goods Program – From time to time, the Company offers programs to potential new patients that allow them to obtain free goods (prescription fills) from a pharmacy. T he Company excludes such amounts related to these programs from both gross and net revenue. The cost of product associated with the free goods program is recognized as cost of goods sold in the condensed consolidated statements of operations. Reserves for Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payers, and other indirect customers relating to the Company’s sale of its products. These reserves, as further detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Significant judgments are required in making these estimates. Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted in accordance with the expected value method in Topic 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 estimates detailed below as of June 30, 2021 and, therefore, the transaction price was not reduced further during the six months ended June 30, 2021. 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 — commercial product sales and earnings in the period such variances become known. Significant judgment is required in estimating gross-to-net adjustments considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix, current contract prices under applicable programs, unbilled claims, processing time lags and inventory levels in the distribution channel. Trade Discounts and Allowances — The Company generally provides Customers with discounts which include incentives, such as prompt pay discounts, that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and as a reduction to accounts receivable, net. Product Returns — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending 12 months after its expiration date , which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company’s current return reserve percentage is estimated to be in the single-digits. Adjustments to the returns reserve have been made in the past and may be necessary in the future based on revised estimates to our assumptions. Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product 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 Medicare, 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 product that has 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 prescription drug 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 product that has 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 manufacturing commercial 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. 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 7 – . 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. 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 collaborative agreements, for accounting purposes, represent contracts with customers and therefore are not subject to accounting literature on collaborative agreements. The Company grants licenses to its intellectual property, supplies raw materials 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. The Company does not develop assets jointly with collaboration partners, and does not share in significant risks of their development or commercialization activities. Accordingly, the Company concluded that its collaborative agreements must generally be accounted for pursuant to Topic 606, Revenue from Contracts with Customers. 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. Rather, the Company evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts. The Company concluded there is no material right in these options. The Company follows detailed accounting guidance in measuring revenue and certain judgments affect the application of its revenue policy. For example, in connection with its existing collaboration agreements, the Company has recorded on its condensed consolidated balance sheets short-term and long-term deferred revenue based on its best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on the Company’s current project development plan and, if the development plan should change in the future, the Company may recognize a different amount of deferred revenue over the next 12-month period. Milestone Payments — At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment. PPP loan — On April 10, 2020, the Company received the proceeds from a loan in the amount of approximately $4.9 million (the “PPP loan”) from JPMorgan Chase Bank, N.A., as lender, pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The Company accounted for the PPP loan as a financial liability in accordance with ASC Topic 470, . Accordingly, the PPP loan was recognized as current and long-term debt in the Company’s consolidated balance sheets and is included as PPP loan — current and PPP loan — long term. In addition, a amount of accrued interest is included in accrued expenses and other current liabilities. On July 28, 2021, the Company received notification from the U.S. Small Business Administration (“SBA”) that the full principal amount of the PPP loan was forgiven. See Note 6 – for additional information. Cost of Goods Sold — Cost of goods sold includes material, labor costs and manufacturing overhead. Cost of goods sold also includes a significant 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. The cost of goods sold excludes the cost of insulin purchased under our 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 2015. Cash and 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, 2021 and December 31, 2020, cash equivalents were comprised of money market accounts with 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. The Company presents amounts of restricted cash that will be available for use within 12 months of the reporting date as restricted cash in current assets. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported on the condensed consolidated balance sheets that sum to amounts reported on the condensed consolidated statements of cash flows (in thousands): June 30, 2021 December 31, 2020 June 30, 2020 Cash and cash equivalents $ 62,522 $ 67,005 $ 63,222 Restricted cash — 158 316 Total cash, cash equivalents, and restricted cash $ 62,522 $ 67,163 $ 63,538 Held-to-Maturity Investments — The Company’s investments generally consist of commercial paper, corporate notes or bonds and U.S. Treasury securities. For the three and six months ended June 30, 2021, the Company held short-term and long-term investments of debt securities, including commercial paper and bonds. The Company intends to hold its investments until maturity and are therefore stated at amortized cost. Those 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 our condensed consolidated balance sheets. The amortization of the Company’s investments is recognized as interest expense in the condensed consolidated statements of operations and was approximately $0.1 million for the three and six months ended June 30, 2021. There was no such amortization for the three or six months ended June 30, 2020. Available-for-Sale Investment — In June 2021, the Company invested $3.0 million in Thirona Bio, Inc. (“Thirona”) and received a $3.0 million convertible promissory note (the “Thirona convertible note”). Unless earlier converted into conversion shares pursuant to the note purchase agreement, the principal and accrued interest shall be due and payable by Thirona on demand by the Company at any time after the maturity date of December 2022. Interest shall accrue at a rate of 6% per annum. The Thirona convertible note is a general unsecured obligation of Thirona. The Thirona convertible note is classified as an available-for-sale security and is included in other assets in the condensed consolidated balance sheet. Available-for-sale investments are subsequently measured at fair value. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income until realized. The Company determines fair value of its available-for-sale investments using level 3 inputs. As of June 30, 2021, the Company evaluated the fair value of its investment in Thirona and determined that the fair value approximates the carrying value of $3.0 million. In June 2021, the Company and Thirona also entered into a collaboration agreement to develop a compound for the treatment of fibrotic lung diseases. See Note 7 – for additional information. Concentration of Credit Risk — Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents and investments. Cash and cash equivalents are held in high credit quality institutions. Cash equivalents consist of interest-bearing money market accounts. Investments generally consist 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 Doubtful Accounts — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for doubtful accounts 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 doubtful accounts. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company’s customers have the right of setoff for these amounts against the related accounts receivable. Pre-Launch Inventory — An improvement to the manufacturing process for the Company’s primary excipient, fumaryl diketopiperazine (“FDKP”) was demonstrated to be viable and management expects to realize an economic benefit in the future as a result of such process improvement. Accordingly, the Company is required to assess whether to capitalize inventory costs related to such excipient prior to regulatory approval of the new supplier and the improved manufacturing process. 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 achieving regulatory approvals for the Company’s manufacturing process, feedback from 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 regulatory approval process; in the interim, the Company mus |
Accounts Receivable
Accounts Receivable | 6 Months Ended |
Jun. 30, 2021 | |
Receivables [Abstract] | |
Accounts Receivable | 2. Accounts Receivable Accounts receivable, net consists of the following (in thousands): June 30, 2021 December 31, 2020 Accounts receivable – commercial Accounts receivable, gross $ 8,467 $ 8,090 Wholesaler distribution fees and prompt pay discounts (1,335 ) (1,205 ) Reserve for returns (2,928 ) (2,667 ) Total accounts receivable – commercial, net 4,204 4,218 Accounts receivable – collaborations and services 2,101 — Total accounts receivable, net $ 6,305 $ 4,218 As of June 30, 2021 and December 31, 2020, the allowance for doubtful accounts was de minimis |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | 3. Inventories Inventories consist of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 2,479 $ 1,393 Work-in-process 3,095 2,484 Finished goods 1,908 1,096 Total inventory $ 7,482 $ 4,973 Work-in-process and finished goods as of June 30, 2021 and December 31, 2020 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 2015. Raw materials inventory included $0.8 million of pre-launch inventory as of June 30, 2021 and December 31, 2020, which consisted of FDKP received in November 2019 that will be used to manufacture Afrezza under an enhanced manufacturing process for FDKP. The Company expects to receive FDA approval of the new source of FDKP in 2023, after which the pre-launch raw materials inventory will be reclassified as raw materials inventory for use in the manufacturing of Afrezza and Tyvaso DPI. 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. Inventory that was forecasted to become obsolete due to expiration is recorded in costs of goods sold in the condensed consolidated statements of operations. For the six months ended June 30, 2020, there was an inventory write-off of $0.5 million as a result of this assessment. There was no inventory write-off for the three and six months ended June 30, 2021. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment Property and equipment consists of the following (in thousands): Estimated Useful Life (Years) June 30, 2021 December 31, 2020 Land — $ 875 $ 875 Buildings 39-40 17,389 17,389 Building improvements 5-40 37,717 37,543 Machinery and equipment 3-15 55,081 55,054 Furniture, fixtures and office equipment 5-10 3,004 3,004 Computer equipment and software 3 8,319 8,319 Construction in progress — 3,072 503 125,457 122,687 Less accumulated depreciation (97,318 ) (96,820 ) Total property and equipment, net $ 28,139 $ 25,867 Depreciation expense related to property and equipment for the three and six months ended June 30, 2021 and 2020 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Depreciation Expense $ 481 $ 448 $ 941 $ 891 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities were comprised of the following (in thousands): June 30, 2021 December 31, 2020 Salary and related expenses $ 10,318 $ 11,250 Discounts and allowances for commercial product sales 4,035 3,688 Accrued interest 2,132 519 Deferred lease liability 1,351 1,422 Milestone rights liability — current 1,088 1,337 Danbury facility buildout 1,055 — Professional fees 521 533 Sales and marketing services 347 99 Other 1,559 859 Total accrued expenses and other current liabilities $ 22,406 $ 19,707 Included in salary and related expenses is approximately $1.0 million of deferred social security taxes as permitted under the CARES Act. The Company was permitted to defer the employer share of social security taxes otherwise owed on dates beginning March 27, 2020 and ending December 31, 2020. The amount of the deferral was based on wages paid from April through December 2020. The Company received notification of forgiveness by the SBA for the full principal balance of the PPP loan as discussed in Note 6 – Borrowings |
Borrowings
Borrowings | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Borrowings | 6 . Carrying amount of principal borrowings consist of the following (in thousands): June 30, 2021 December 31, 2020 Senior convertible notes $ 223,217 $ — MidCap credit facility 38,614 49,335 Mann Group promissory notes (1) 18,425 63,027 PPP loan 4,873 4,873 2024 convertible notes — 5,000 Total debt — net carrying amount $ 285,129 $ 122,235 ___________________ (1) The amendment to the Mann Group convertible note resulted in a substantial premium of $22.1 million based on the fair value post modification, which contributed to the loss on extinguishment in the condensed consolidated statement of operations for the three and six months ended June 30, 2021 and was recognized as additional paid-in capital in the condensed consolidated balance sheet as of June 30, 2021. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company. The following table provides a summary of the Company’s debt and key terms as of June 30, 2021: Amount Due Terms June 30, 2021 December 31, 2020 Annual Interest Rate Maturity Date Conversion Price Senior convertible notes $230.0 million $ — 2.50% March 2026 $5.21 per share MidCap credit facility (1) $40.0 million $50.0 million one-month LIBOR (1% floor) plus 6.25% (1 ) August 2025 (1 ) N/A Mann Group convertible note $18.4 million (plus $0.2 million accrued interest paid-in-kind) $28.0 million (plus $0.6 million accrued interest paid-in-kind) 2.50% (2 ) December 2025 (2 ) $2.50 per share Mann Group non-convertible note (3) $ — $35.1 million (plus $3.6 million accrued interest paid-in-kind) 7.00% November 2024 N/A PPP loan (4) $4.9 million $4.9 million 0.98% April 2022 N/A 2024 convertible notes (5) $ — $5.0 million 5.75% November 2024 $3.00 per share ____________________ (1) In April 2021, the Company prepaid $10.0 million principal balance and amended the MidCap credit facility. The interest rate prior to the amendment was one-month LIBOR (2% floor) plus 6.75% and the maturity date was in August 2024. (2) In April 2021, the Mann Group convertible note was amended. The interest rate prior to the amendment was 7.00% and the maturity date was in November 2024. (3) In April 2021, the Company prepaid $35.1 million principal balance as well as accrued unpaid interest. (4) In July 2021, the Company received full forgiveness from the SBA for the $4.9 million principal balance of the PPP loan. (5) In February 2021, the $5.0 million principal balance was converted into 1,666,667 shares of the Company’s common stock. The maturities of our borrowings as of June 30, 2021 are as follows (in thousands): Amounts 2021 $ 4,061 2022 812 2023 6,667 2024 38,425 Thereafter 243,333 Total principal payments 293,298 Discount (1,386 ) Debt issuance cost (6,783 ) Total debt — net carrying amount $ 285,129 Senior convertible notes – On March 4, 2021, the Company issued $200.0 million aggregate principal amount of Senior convertible notes in a private offering. Pursuant to an option to purchase additional senior convertible notes in the purchase agreement between the Company and the initial purchasers of the Senior convertible notes, the Company issued an additional $30.0 million aggregate principal amount of Senior convertible notes on March 15, 2021. 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. The Senior convertible notes will bear cash interest from March 4, 2021 at an annual rate of 2.50% payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2021. The Senior convertible notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding December 1, 2025, only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2021 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock, par value $0.01 per share, for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the Senior convertible notes on each applicable trading day; (2) during the five business day period after any ten consecutive trading day period in which the trading price (as defined in the Indenture) per $ 1,000 principal amount of the Senior convertible notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of the Common Stock and the conversion rate on each such trading day; (3) if the Company calls such Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date, but only with respect to the Senior convertible notes called (or deemed called) for redemption; or (4) upon the occurrence of specified corporate events as set forth in the Indenture. On or after December 1, 2025 until the close of business on the business day immediately preceding the maturity date, holders may convert all or any portion of their Notes at any time, regardless of the foregoing circumstances. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of the Common Stock or a combination of cash and shares of Common Stock, at the Company’s election, in the manner and subject to the terms and conditions provided in the Indenture. The initial conversion rate is 191.8281 shares of Common Stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $5.21 per share of Common Stock). The initial conversion price of the Senior convertible notes represents a premium of approximately 30% to the last reported sale price of the Common Stock on the Nasdaq Global Market on March 1, 2021. The conversion rate for the Senior convertible notes is subject to adjustment under certain circumstances in accordance with the terms of the Indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date of the Senior convertible notes or if the Company delivers a notice of redemption in respect of the Senior convertible notes, the Company will, in certain circumstances, increase the conversion rate of the Senior convertible notes for a holder who elects to convert its Notes in connection with such a corporate event or convert its Notes called for redemption during the related redemption period (as defined in the Indenture), as the case may be. The Company may not redeem the Senior convertible notes prior to March 6, 2024. The Company may redeem for cash all or any portion of the Senior convertible notes, at its option, on or after March 6, 2024 and prior to the 36th scheduled trading day immediately preceding the maturity date, if the last reported sale price of Common Stock has been at least 130% of the conversion price for the Senior convertible notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the Senior convertible notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If the Company elects to redeem less than all of the outstanding Notes, at least $75.0 million aggregate principal amount of 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 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 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, 2021, the unamortized debt issuance cost was $6.8 million. MidCap credit facility — I n August 2019, the Company entered into the MidCap credit facility and borrowed the first advance of $40.0 million (“Tranche 1”) in August 2019 and the second advance of $10.0 million (“Tranche 2”) in December 2020. In April 2021, $10.0 million was prepaid. Under the terms of the MidCap credit facility, a third advance of $60.0 million (“Tranche 3”) will be available to the Company between January 1, 2022 and June 30, 2022, subject to the satisfaction of certain milestone conditions associated with Tyvaso DPI through the Company’s collaboration with United Therapeutics (see Note 7 – ). In December 2019, the Company entered into the first amendment to the MidCap credit facility, pursuant to which the parties agreed to (i) amend the financial covenant relating to trailing twelve month minimum Afrezza Net Revenue (as defined in the MidCap credit facility) requirements, (ii) add a condition to the third advance In August 2020, the Company entered into the second amendment to the MidCap credit facility, pursuant to which the parties agreed that no breach of the minimum Afrezza net revenue covenant for any trailing twelve-month reporting period between July 31, 2020 and November 30, 2020 will be deemed to occur if the Company delivers satisfactory evidence that it had unrestricted cash of at least $40.0 million. Without this amendment, the Company would have been in violation of the minimum Afrezza net revenue covenant as of September 30, 2020. In November 2020, the Company entered into the third amendment to the MidCap credit facility, pursuant to which the parties agreed to (i) amend the conditions to draw Tranche 2, which had become unavailable, such that the advance became available and was, in fact, funded to the Company on December 1, 2020, (ii) amend the conditions to Tranche 3 such that the third advance was available upon the satisfaction of certain conditions, including certain milestone conditions associated with Tyvaso DPI, (iii) add a covenant that requires the marketing of Tyvaso DPI if the third advance is funded, (iv) amend the financial covenant relating to trailing twelve month minimum Afrezza Net Revenue (as defined in the MidCap credit facility) requirements, (v) increase the minimum cash covenant to $30.0 million at all times, (vi) extend the interest only period until September 1, 2022, at which time principal on each term loan advance is payable in 24 equal monthly installments, and (vii) amend the prepayment fees. In connection with the extension of the interest only period for the $40.0 million drawn under Tranche 1, a $0.2 million loss on extinguishment was recognized in the consolidated statements of operations for the year ended December 31, 2020. The funding of $10.0 million under Tranche 2 resulted in the recognition of approximately $0.3 million of debt discount and a de minimis In December 2020, the Company entered into the fourth and fifth amendments to the MidCap credit facility. Pursuant to the fourth amendment, MidCap consented to the acquisition by the Company of QrumPharma, Inc. Pursuant to the omnibus joinder and fifth amendment, QrumPharma was joined as a borrower to the MidCap credit facility and to certain related financing documents. In March 2021 the Company entered into the sixth amendment to the MidCap credit facility to accommodate the issuance of the Senior convertible notes. On April 22, 2021, the Company entered into the seventh amendment of the MidCap credit facility, pursuant to which the parties agreed to, among other things, (i) increase the amount available under the third advance from $25.0 million to $60.0 million and extend the date through which the third advance is available to June 30, 2022, (ii) amend the conditions to the third advance of $60.0 million being available to draw, including certain milestone conditions associated with Tyvaso DPI, (iii) remove the Company’s obligation to issue a warrant to purchase shares of the Company’s common stock upon drawing down the third advance, (iv) extend the interest-only period until September 1, 2023 and extend the maturity date until August 1, 2025, (v) amend the financial covenant relating to trailing 12 month minimum Afrezza net revenue, (vi) decrease the minimum cash covenant, (vii) decrease the interest rate on any amounts outstanding, now or in the future, under the MidCap credit facility, (viii) permit the Company to make certain acquisitions, subject to requirements, and (ix) permit the Company to make investments of up to an additional $9.0 million so long as the Company has $90.0 million or more of unrestricted cash and short-term investments following such investment. Concurrent with entering into this amendment, the Company made a $10.0 million principal prepayment against outstanding term loans under the MidCap credit facility and paid a related $1.0 million exit fee in lieu of the unaccrued portion of the original exit fee and prepayment penalties that would otherwise have been due with respect to the partial prepayment. Tranche 1, Tranche 2 and, if borrowed, Tranche 3, each accrue interest at an annual rate equal to the lesser of (i) 8.25% and (ii) the one-month LIBOR (subject to a one-month LIBOR floor of 1.00%) plus 6.25%. Interest on each term loan advance is due and payable monthly in arrears. Principal on each term loan advance under Tranche 1, Tranche 2 and, if applicable, Tranche 3 is payable in 24 equal monthly installments beginning September 1, 2023, until paid in full on August 1, 2025. The Company has the option to prepay its existing term loans, in whole or in part, subject to early termination fees in an amount equal to 3.00% of principal prepaid if prepayment occurs on or prior to April 22, 2022; 2.00% of principal prepaid if prepayment occurs on or after April 23, 2022 through and including April 22, 2023; and 1.00% of principal prepaid if prepayment occurs on or after April 23, 2023 through the maturity date. Tranche 3 will be subject to a similar scheme of early termination fees measured from the anniversary of the funding date for such tranche, if ever. The prepayment penalty of $ 1.0 million related to the payment of $ 10.0 million was capitalized and will be amortized over the remaining life of the debt. As of June 30, 2021, the unamortized debt discount was $ 0.4 million and the unamo rtized prepayment penalty was $ 0.9 million . The Company’s obligations under the MidCap credit facility are secured by a security interest on substantially all of its assets, including intellectual property. The MidCap credit facility, as amended, contains customary affirmative covenants and customary negative covenants limiting the Company’s ability and the ability of the Company’s subsidiaries to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions. The Company must also comply with a financial covenant relating to trailing twelve month minimum Afrezza net revenue, tested on a monthly basis, unless the Company has $90.0 million or more of unrestricted cash and short-term investments. The Company is also subject to a minimum cash covenant of $10.0 million at all times; however, this covenant will be eliminated in the event that Tyvaso DPI is approved by the FDA. As of June 30, 2021, the Company was in compliance with the financial and minimum cash covenants. The MidCap credit facility also contains customary events of default relating to, among other things, payment defaults, breaches of covenants, a material adverse change, listing of the Company’s common stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, the agent and the lenders may declare all or a portion of the Company’s outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the MidCap credit facility. During the existence of an event of default, interest on the term loans could be increased by 2.00%. The Company also agreed to issue warrants to purchase shares of the Company’s common stock (the “MidCap warrants”) upon the drawdown of Tranches 1 and 2 in an aggregate amount equal to 3.25% of the amount drawn, divided by the exercise price per share for that tranche. The exercise price per share is equal to the volume-weighted average closing price of the Company’s common stock for the ten business days immediately preceding the second business day before the issue date. As a result of Tranche 1, the Company issued warrants to purchase an aggregate of 1,171,614 shares of the Company’s common stock, at an exercise price equal to $1.11 per share. As a result of Tranche 2, the Company issued warrants to purchase an aggregate of 111,853 shares of the Company’s common stock, at an exercise price equal to $2.91 per share. The MidCap warrants are immediately exercisable and expire on the earlier to occur of the seventh anniversary of the respective issue date or, in certain circumstances, the closing of a merger, sale or other consolidation transactions in which the consideration is cash, stock of a publicly traded acquirer, or a combination thereof. The Company determined that these warrants met the criteria for equity classification and accounted for such warrants in additional paid-in capital. Mann Group promissory notes — In August 2019, the Company issued a $35.0 million note that is convertible into shares of the Company’s common stock at $2.50 per share (the “Mann Group convertible note”) and issued a non-convertible note to Mann Group in an aggregate principal amount of $35.1 million (the “Mann Group non-convertible note” and , together with the Mann Group convertible note, the “Mann Group promissory notes”) as part of a restructuring of its then existing indebtedness to Mann Group. The Mann Group promissory notes each accrued interest at the rate of 7.00% per year on the principal amount, payable quarterly in arrears on the first day of each calendar quarter beginning October 1, 2019. On April 22, 2021, the Company and Mann Group entered into an amendment of the Mann Group convertible note, pursuant to which the parties agreed to (i) reduce the interest rate from 7.0% to 2.5% effective on April 22, 2021, and (ii) extend the maturity date from November 3, 2024 to December 31, 2025. The amendment to the Mann Group convertible note resulted in a debt extinguishment with a substantial premium based on the fair value post extinguishment. The fair value in excess of the face amount of $18.4 million contributed to a loss on extinguishment of $22.1 million in our condensed consolidated statement of operations for the three and six months ended June 30, 2021 and resulted in a corresponding debt premium of $22.1 million which was recognized as additional paid-in capital in our condensed consolidated balance sheet as of June 30, 2021. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company. de minimis The principal and any accrued and unpaid interest under the Mann Group convertible note may be converted, at the option of Mann Group, at any time on or prior to the close of business on the business day immediately preceding the stated maturity date, into shares of the Company’s common stock at a conversion rate of 400 shares per $1,000 of principal and/or accrued and unpaid interest, which is equal to a conversion price of $2.50 per share. The conversion rate will be subject to adjustment under certain circumstances described in the Mann Group convertible note. Interest on the convertible note will be payable in kind by adding the amount thereof to the principal amount; provided that with respect to interest accruing from and after January 1, 2021, the Company may, at its option, elect to pay any such interest on any interest payment date, if certain conditions are met, in shares of the Company’s common stock at a price per shall equal to the last reported sale price on the trading day immediately prior to the payment date. Pursuant to the terms of the Mann Group convertible note, Mann Group converted $3.0 million of accrued interest and $7.0 million of principal into 1.2 million shares and 2.8 million shares, respectively, of the Company’s common stock in the fourth quarter of 2020. During the six months ended June 30, 2021, Mann Group converted $0.4 million of interest and $9.6 million of principal into 4,000,000 shares of common stock. On April 22, 2021, the Company repaid the entire principal amount of $35.1 million outstanding under the Mann Group non-convertible note, together with all accrued and unpaid interest thereon. PPP loan – On April 10, 2020, the Company received the proceeds from the PPP loan from JPMorgan Chase Bank, N.A., as lender, in the amount of approximately $4.9 million pursuant to the PPP of the CARES Act. On July 28, 2021, the Company received notification from the SBA that the full principal amount of the PPP loan was forgiven. Prior to being forgiven, the PPP loan was evidenced by a promissory note dated April 9, 2020 that matured on April 9, 2022 and bore interest at a rate of 0.98% per annum (which was being deferred). The Company used all proceeds from the PPP loan to retain employees, maintain payroll and make lease, interest and utility payments. 2024 convertible notes — In August 2019, the Company issued 5.75% convertible senior subordinated exchange notes due November 2024 (the “ 2024 convertible notes”) pursuant to an indenture, dated as of August 6, 2019, between the Company and U.S. Bank National Association, as trustee (the “2019 Indenture”). The 2024 convertible notes were the Company’s general, unsecured obligations, and were subordinated in right of payment to the indebtedness incurred pursuant to the MidCap credit facility. The 2024 convertible notes ranked equally in right of payment with the Company’s other unsecured senior debt. The 2024 convertible notes accrued interest at the rate of 5.75% per year on the principal amount, payable semiannually in arrears on February 15 and August 15 of each year, beginning February 15, 2020, with interest accruing from August 6, 2019. Interest on the 2024 convertible notes was payable in cash or, at the option of the Company if certain conditions are 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 interest payment date. The 2024 convertible notes were convertible, at the option of the holder, 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 333.3333 shares per $1,000 principal amount of 2024 convertible notes, which is equal to a conversion price of approximately $3.00 per share. In February 2021, the Company converted the $5.0 million 2024 convertible notes with the issuance of 1,666,667 shares of the Company’s common stock. Amortization of debt discount and debt issuance cost related to all borrowings for the three and six months ended June 30, 2021 and 2020 were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Amortization of debt discount $ 86 $ 90 $ 146 $ 179 Amortization of debt issuance cost 363 27 488 55 Milestone Rights — As of June 30, 2021 and December 31, 2020, the remaining Milestone Rights liability balance was $5.9 million and $7.3 million, respectively, which was based on initial fair value estimates calculated using the income approach and reduced by milestone achievement payments made. During the first quarter of 2021, the Company achieved the second Afrezza net sales milestone specified by the Milestone Rights. The milestone carrying value of the Milestone Rights liability related to the $5.0 million payment, which was made in the second quarter of 2021, was approximately $1.3 million, which represented the fair value as determined in 2013 (the most recent measurement date). The agreement with the Milestone Purchasers that provides for the Milestone Rights 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. |
Collaboration, Licensing and Ot
Collaboration, Licensing and Other Arrangements | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration, Licensing and Other Arrangements | 7. Collaboration, Licensing and Other Arrangements Revenue from collaborations and services for the three and six months ended June 30, 2021 and 2020 are as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 UT License Agreement $ 12,163 $ 7,978 $ 21,163 $ 15,956 Vertice Pharma Co-Promotion Agreement 856 — 1,147 — Receptor CLA 165 63 175 125 Cipla License and Distribution Agreement 37 35 73 72 Other 83 — 83 — UT Research Agreement — 53 — 211 Total revenue from collaborations and services $ 13,304 $ 8,129 $ 22,641 $ 16,364 United Therapeutics License Agreement — In September 2018, the Company and United Therapeutics Corporation (“United Therapeutics” or “UT”) entered into an exclusive global license and collaboration agreement (the “UT License Agreement”) for the rights to the Company’s dry powder formulation of treprostinil (“Tyvaso DPI”) and associated inhalation delivery devices. Under the UT License Agreement, UT is responsible for global development, regulatory and commercial activities with respect to Tyvaso DPI. The Company is responsible for manufacturing clinical supplies and commercial supplies of Tyvaso DPI. Under the terms of the UT License Agreement, the Company received an upfront payment of $45.0 million in October 2018 and four $12.5 million milestone payments between April 2019 and November 2020. The Company will also be entitled to receive low double-digit royalties on net sales of Tyvaso DPI as well as a manufacturing margin on commercial supplies of the product. UT, at its option, may expand the scope of the products covered by the UT License Agreement to include products with certain other active ingredients for the treatment of pulmonary arterial hypertension. Each such optioned product would be subject to UT’s payment to the Company of up to $40.0 million in additional option exercise and development milestone payments, as well as a low double-digit royalty on net sales of any such product. At the inception of the agreement, the Company identified one distinct, performance obligation. The Company determined that the key deliverables include the license, supply of product to be used in clinical development, and certain research services upon achievement of specified development targets. Due to the specialized and unique nature of these services and their direct relationship with the license, the Company has determined that these deliverables represent one distinct bundle and thus, one performance obligation. The Company also determined that UT’s option to expand the scope of the products to include products with other active ingredients is not a material right, and thus, not a performance obligation at the onset of the agreement. The consideration for the option will be accounted for upon exercise of the option. The Company expected to complete the activities specified in the initial development plan and to achieve the milestone events (including a $2.7 million increase in total consideration pursuant to the agreement executed in December 2020) by December 31, 2021 for total consideration of approximately $105.8 million, which included an upfront payment, four milestone payments, various pass-through costs and payments for clinical supplies. Through March 2021, the Company recognized revenue ratably over a 13-quarter In May 2021, UT and the Company updated the development plan under the UT License Agreement to provide for additional process-development and stability-testing activities as well as the expansion of the Company’s commercial manufacturing capacity. The activities and deliverables under the current development plan resulted in four distinct performance obligations which include: (1) the continued development and approval process for a new drug application (“NDA”) (“R&D Services”); (2) certain pre-commercial services in preparation for commercial launch of Tyvaso DPI “(Pre-Commercial Services”); (3) development activities for the next generation of Tyvaso DPI (“Next-gen R&D Services”); and (4) certain design and construction activities in anticipation of expansion of the Company’s commercial manufacturing facility (“Facility Expansion Services”). The total consideration for the updated development plan of $50.2 million was allocated to the four distinct performance obligations based on management’s assessment of the stand-alone selling price of each performance obligation. Consideration of $0.7 million for additional clinical supplies was added in June 2021 for a total of $50.9 million. The R&D Services performance obligation was allocated a total of $18.3 million, which will be recognized on a ratable basis from May 2021 through October 2021; the estimated date when the performance obligation for the initial development services will be substantially completed. The Company allocated $4.6 million, $7.2 million, and $20.7 million to the Pre-Commercial Services, Next-gen R&D Services, and Facility Expansion Services performance obligations, respectively. The Company determined that the Pre-Commercial Services and Next-gen R&D Services performance obligations will be satisfied over time using the input method based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer. The Facility Expansion Services performance obligation would be recognized as control of manufactured products is transferred to the customer. The Company will also be acting as agent for the procurement of equipment for the manufacturing expansion for UT (the “UT Equipment”). The $5.3 million received from UT for the UT Equipment was recognized as deposits from customer on our condensed consolidated balance sheet and will be released as the title is transferred to UT. As of June 30, 2021, deferred revenue consisted of $20.0 million, which was classified as current on the condensed consolidated balance sheet. Vertice Pharma Co-Promotion Agreement — In December 2020, the Company entered into a co-promotion agreement with Vertice Pharma where the Company’s sales force will promote Thyquidity to adult endocrinologists, pediatric endocrinologists and other healthcare providers who treat hypothyroidism. Following the commercial launch of Thyquidity, in consideration of the sales and promotional activities provided by the Company’s sales force, Vertice is obligated to pay fixed quarterly payments to the Company, as well as variable consideration based on gross profits resulting from all sales of Thyquidity. Vertice Pharma launched Thyquidity in collaboration with the Company in February 2021. At inception of the agreement, the Company identified a single performance obligation that the Company will satisfy over time. The Company estimates the total transaction price is approximately $6.3 million, consisting of fixed consideration and the unconstrained amount of estimated variable consideration, which is based on gross profit applied to defined revenue benchmarks. The amount of variable consideration is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur and the payments will be received. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price 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 in the period of adjustment. The total transaction price will be recognized over a two-year Thirona Collaboration Agreement — In June 2021, the Company and Thirona entered into a collaboration agreement to evaluate the therapeutic potential of Thirona’s compound for the treatment of pulmonary fibrosis. If initial studies are promising, the Company can exercise certain rights to seek a full license to the compound for clinical development and commercialization. The parties will perform their respective obligations and provide reasonable support for research, clinical development and regulatory strategy. The collaboration agreement will be accounted for under ASC 808, Collaborative Agreements; however, no consideration will be exchanged between the parties. The Company will expense the costs incurred as cost of revenue — collaborations and services in the condensed consolidated statements of operations. Biomm Supply and Distribution Agreement — In May 2017, the Company and 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 have now been received. Biomm commenced product sales in January 2020. In September 2019, the Company delivered its first shipment of Afrezza to Biomm and recorded it as net revenue — commercial product sales During the second quarter of 2020, the Company sold $0.2 million of product to Biomm. No additional shipments were made to Biomm in 2020 or the first six months of 2021. Cipla License and Distribution Agreement — In May 2018, the Company and Cipla Ltd. (“Cipla”) entered into an exclusive agreement for the marketing and distribution of Afrezza in India and the Company received a $2.2 million nonrefundable license fee. Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla. The Company has the potential to receive an additional regulatory milestone payment, minimum purchase commitment revenue and royalties on Afrezza sales in India once cumulative gross sales have reached a specified threshold. The nonrefundable licensing fee was recorded in deferred revenue and is being recognized in net revenue – collaborations over 15 years, representing the estimated period to satisfy the performance obligation. The additional milestone payments represent variable consideration for which the Company has not recognized any revenue because of the uncertainty of obtaining marketing approval. As of June 3 0 , 202 1 , the d eferred revenue balance was $ million , of which $ million i s classified as current and $ 1.6 million is classified as long term in the condensed consolidated balance sheets . AMSL Distribution Agreement — In May 2019, the Company entered into an exclusive marketing and distribution agreement with the AMSL Diabetes division of Australasian Medical & Scientific Ltd. (“AMSL Diabetes”) for the commercialization of Afrezza in Australia. Under the terms of this agreement, AMSL Diabetes is responsible for obtaining regulatory and reimbursement approvals to distribute Afrezza in Australia. Upon regulatory approval, AMSL Diabetes will conduct sales, marketing, and customer support and distribution activities whereas the Company will be responsible for the supply and manufacturing of Afrezza. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 8. 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. 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 cash equivalents, MidCap credit facility, Mann Group promissory notes, 2024 convertible notes, Senior convertible notes and Milestone Rights liabilities are disclosed below. Cash Equivalents and Restricted Cash — 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. As of June 30, 2021 and December 31, 2020, the Company held $62.5 million and $67.0 million, respectively, of cash and cash equivalents. The Company held zero and $0.2 million in restricted cash as of June 30, 2021 and December 31, 2020, which are comprised of money market funds. Restricted cash was used to collateralize a letter of credit. The fair value of these money market funds was determined by using quoted prices for identical investments in an active market (Level 1 in the fair value hierarchy). Investments — Investments consist of highly liquid investments that are intended to facilitate liquidity and capital preservation. The fair value of investments approximates their carrying value. The measurement of which is based on a market approach using quoted market values (Level 1 in the fair value hierarchy). As of June 30, 2021, the Company held $100.0 million of short-term investments and $39.0 million of long-term investments. 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, 2021 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (1) $ 223.2 $ 257.0 $ 257.0 MidCap credit facility (2) 38.6 40.5 40.5 Mann Group convertible notes (3) 18.4 44.9 44.9 PPP loan (4) 4.9 4.8 4.8 Milestone rights (5) 5.9 15.0 15.0 ____________________ (1) Fair value determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 12%, volatility of 96% and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2% would result in a fair value of $245.4 million and $269.8 million, respectively. (2) Fair value determined by applying a discounted cash flow analysis with a hypothetical yield of 10%. A change in yield of + or – 2% would result in a fair value of $38.5 million and $42.7 million, respectively. (3) The April 2021 amendment to the Mann Group convertible note resulted in a substantial premium of $22.1 million based on the fair value post modification which was recognized as additional paid-in capital in the condensed consolidated balance sheet as of June 30, 2021. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company. The fair value assessed as of June 30, 2021 was determined by applying a discounted cash flow analysis with a hypothetical yield of 12% and volatility of 96% 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 $43.9 million and $45.9 million, respectively. (4) Fair value determined by applying a discounted cash flow analysis with a hypothetical yield of %. A change in yield of + or – 2 % would result in a fair value of $ 4.7 million and $ 4.8 million, respectively. (5) Fair value determined by applying a Monte Carlo simulation. December 31, 2020 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: (1) MidCap credit facility $ 49.3 $ 55.4 $ 55.4 Mann Group promissory notes (2) 63.0 78.9 78.9 2024 convertible notes 5.0 7.0 7.0 PPP loan 4.9 4.7 4.7 Milestone rights 7.3 19.8 19.8 ____________________ (1) Fair value measurements were based on a discounted cash flow model, except for the Milestone rights for which a Monte Carlo simulation was applied. (2) Mann Group promissory notes consisted of the following carrying values and fair values: Mann Group convertible notes carrying value of $28.0 million and fair value of $52.2 million. Mann Group non-convertible notes carrying value of $35.1 million and fair value of $26.7 million. Milestone Rights Liability — The fair value measurement of the Milestone Rights liability is sensitive to the discount rate and the timing of achievement of milestones. The Company utilized Monte-Carlo Simulation Method to simulate the Net Sales under a neutral framework to estimate the payment. The Company then discounted the future expected payments at cost of debt with a term equal to the simulated time to payout based on cumulative sales. |
Common and Preferred Stock
Common and Preferred Stock | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Common and Preferred Stock | 9. The Company is authorized to issue 400,000,000 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, 2021 and December 31, 2020, 249,617,550 and 242,117,089 shares of common stock, respectively, were issued and outstanding and no shares of preferred stock were outstanding. In February 2018 In the first quarter of 2021, Mann Group converted $0.4 million of interest and $9.6 million of principal into 4,000,000 shares of common stock in accordance with the terms of the Mann Group convertible note. See Note 6 – Borrowings In February 2021, the Company converted $5.0 million principal amount of 2024 convertible notes into 1,666,667 Borrowings . For the three and six months ended June 30, 2021, the Company received de minimis |
Earnings Per Common Share ("EPS
Earnings Per Common Share ("EPS") | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Earnings Per Common Share ("EPS") | 10. Earnings per Common Share (“EPS”) Basic EPS excludes dilution for potentially dilutive securities and is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted EPS reflects the potential dilution under the treasury method that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. For periods where the Company has presented a net loss, potentially dilutive securities are excluded from the computation of diluted EPS as they would be antidilutive. The following tables summarize the components of the basic and diluted EPS computations (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 EPS — basic and diluted: Net loss (numerator) $ (35,523 ) $ (10,252 ) $ (48,439 ) $ (19,574 ) Weighted average common shares (denominator) 249,295 213,880 247,970 212,943 Net loss per share $ (0.14 ) $ (0.05 ) $ (0.20 ) $ (0.09 ) Common shares issuable represents incremental shares of common stock which consist of stock options, restricted stock units, warrants, and shares that could be issued upon conversion of the Senior convertible notes and the Mann Group convertible notes. Potentially dilutive securities outstanding that are considered antidilutive are summarized as follows (in shares): Six Months Ended June 30, 2021 2020 Senior convertible notes 44,120,463 — Mann Group convertible notes 7,370,000 14,000,000 Warrants associated with MidCap credit facility 1,283,467 1,171,614 Common stock options and PNQs 11,092,080 13,197,927 RSUs and Market RSUs (1) 7,986,898 2,501,713 Employee stock purchase plan 250,000 276,154 2024 convertible notes — 1,666,667 Common stock warrants — 31,851 Total shares 72,102,908 32,845,926 ____________________ (1) Market RSUs are included at the maximum share delivery percentage. |
Stock-Based Compensation Expens
Stock-Based Compensation Expense | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation Expense | 11. Stock-Based Compensation Expense During the six months ended June 30, 2021, the Company granted the following awards: Three Months Ended Three Months Ended Six Months Ended March 31, 2021 June 30, 2021 June 30, 2021 Employee awards: RSUs 370,137 (1) 1,476,059 (2) 1,846,196 Market RSUs — 918,775 (3) 918,775 Non-employee director RSUs — 316,232 (4) 316,232 Total awards 370,137 2,711,066 3,081,203 ____________________ (1) RSUs had a weighted average (2) RSUs had a weighted average grant (3) Market RSUs had a grant date fair value th th th th th (4) RSUs had a weighted average grant date fair value As of June 30, 2021, there was $3.4 million of unrecognized stock-based compensation expense related to options and PNQs, which is expected to be recognized over a weighted average period of approximately 1.6 years, and $12.6 million and $12.5 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 3.4 and 2.6 years, respectively. Total stock-based compensation expense recognized in the condensed consolidated statements of operations for the three months ended June 30, 2021 and 2020 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 RSUs and options $ 3,819 $ 2,122 $ 5,625 $ 3,188 Employee stock purchase plan 107 63 236 125 Total stock compensation expense $ 3,926 $ 2,185 $ 5,861 $ 3,313 Employee Stock Purchase Plan The Company provides all employees, including executive officers, the ability to purchase our common stock at a discount under our 2004 employee stock purchase plan (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 our 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 identical to those of all other employees. The Company issued 292,981 and 333,727 shares of common stock pursuant to the ESPP for the six months ended June 30, 2021 and 2020, respectively. There were approximately 1.3 million shares of common stock available for issuance under the ESPP as of June 30, 2021. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. 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. The Company has not recorded any liability for these indemnities in the condensed consolidated balance sheets. However, the Company accrues for losses for any known contingent liability, including those that may arise from indemnification provisions, when future payment is probable and the amount can be reasonably estimated. No such losses have been recorded to date. Litigation — The Company is subject to legal proceedings and claims which arise in the ordinary course of its business. As of June 30, 2021, the Company believes that the final disposition of such matters will not have a material adverse effect on the financial position, results of operations or cash flows of the Company and no accrual has been recorded. The Company maintains liability insurance coverage to protect the Company’s assets from losses arising out of or involving activities associated with ongoing and normal business operations. The Company records a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company’s policy is to accrue for legal expenses in connection with legal proceedings and claims as they are incurred. Following the public announcement in January 2016 of the election by sanofi-aventis U.S. LLC (“Sanofi”) to terminate a license and collaboration agreement (the “Sanofi License Agreement”) between the Company and Sanofi and the subsequent decline in the Company’s stock price, two motions were submitted to the district court at Tel Aviv, Economic Department for the certification of a class action against the Company and certain of its officers and directors. In general, the complaints allege that the Company and certain of its officers and directors violated Israeli and U.S. securities laws by making materially false and misleading statements regarding the prospects for Afrezza, thereby artificially inflating the price of its common stock. The plaintiffs are seeking monetary damages. In November 2016, the district court dismissed one of the actions without prejudice. In the remaining action, the district court ruled in October 2017 that U.S. law will apply to this case. The plaintiff appealed this ruling, and following an oral hearing before the Supreme Court of Israel, decided to withdraw his appeal. Subsequently, in November 2018, the Company filed a motion to dismiss the certification motion. In September 2019, the plaintiff brought a motion to amend his claim, which the court denied in January 2020. The plaintiff appealed this denial to the Supreme Court of Israel, which issued a decision in July 2021 upholding the lower court decision. Subsequently, the plaintiff withdrew his complaint and the district court dismissed the motion to certify, bringing the litigation to an end. Contingencies — In July 2013, the Company entered into a n a greement with the Milestone Purchasers, pursuant to which the Company granted the Milestone R ights to receive payments up to $ 90.0 million upon the occurrence of specified strategic and sales milestones, $ million of which remains payable upon achievement of such milestones (see Note 6 – Borrowings ). The fair value of the Milestone Rights is recorded in the condensed consolidated balance sheet, including $ million in accrued expenses and other current liabilities and $ million in milestone rights liabilit y . Commitments — In July 2014, the Company entered into the Insulin Supply Agreement with Amphastar pursuant to which Amphastar manufactures for and supplies to the Company certain quantities of recombinant human insulin for use in Afrezza. Under the terms of the Insulin Supply Agreement, Amphastar is responsible for manufacturing the insulin in accordance with the Company’s specifications and agreed-upon quality standards. In May 2021, the Company and Amphastar amended the Insulin Supply Agreement to extend the term and restructure the annual purchase commitments. In connection with the amendment, the Company agreed to pay $2.0 million of amendment fees, which were recognized in cost of goods sold for the three and six months ended June 30, 2021. The remaining purchase commitments as of June 30, 2021 and March 31, 2021 (pre-amendment) were as follows: June 30, 2021 March 31, 2021 2021 € 2.0 million € 7.0 million 2022 € 5.4 million € 8.5 million 2023 € 8.7 million € 10.9 million 2024 € 14.6 million € 14.6 million 2025 € 15.5 million € 15.5 million 2026 € 19.4 million € 19.4 million 2027 € 9.2 million € — Pursuant to the amendment, the term of the Insulin Supply Agreement expires on December 31, 2027, 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 Warrants – In August 2019, in connection with the MidCap credit facility, the Company issued warrants to purchase an aggregate of 1,171,614 shares of the Company’s common stock, at an exercise price equal to $1.11 per share, to the lenders. On November 30, 2020, in connection with the third amendment to the MidCap credit facility, the Company issued warrants to purchase an aggregate of 111,853 shares of the Company’s common stock, at an exercise price of $2.91 per share. (see Note 6 – Borrowings ). Vehicle Leases – During the second quarter of 2018, the Company entered into a lease agreement with Enterprise Fleet Management Inc. During the six months ended June 30, 2021, 10 vehicles were removed from the fleet, resulting in a fleet size of 78 vehicles. No gain or loss was recorded. The revised monthly payment inclusive of maintenance fees, insurance and taxes is approximately $69,000. The lease expense is included in selling, general and administrative 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 headquarters in Westlake Village, California. The office lease commenced in August 2017. The Company agreed to pay initial monthly lease payments of $40,951, subject to 3% annual increases, plus the estimated cost of maintaining the property and common areas by the landlord, with a five-month concession from October 2017 through February 2018. The lease also provides for allowances for tenant alterations and maintenance. The lease expires in January 2023 and provides the Company with a five-year the condensed consolidated statements of operations. In November 2017, the Company executed an office lease with Russell Ranch Road II LLC to expand the office space for the Company’s corporate headquarters in Westlake Village, California. The office lease commenced in October 2018. The Company agreed to pay initial monthly lease payments of $35,969, subject to a 3% annual increase, plus the estimated operating cost of maintaining the property by the landlord, which are allocable based an annual assessment made by the landlord. In addition, the Company received reimbursement from the landlord of $56,325 for tenant improvements and was not required to pay a first-year common area maintenance fee. The lease expires in January 2023 and provides the Company with a five-year Lease information is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease costs $ 340 $ 352 $ 685 $ 703 Variable lease costs 114 79 231 180 Cash paid 454 431 916 883 June 30, 2021 December 31, 2020 Weighted average remaining lease term (in years) 1.5 1.9 Weighted average discount rate 7.3 % 7.5 % Future minimum office and vehicle lease payments as of June 30, 2021 and December 31, 2020, are as follows (in thousands): June 30, 2021 December 31, 2020 2021 $ 722 $ 1,494 2022 1,213 1,239 2023 88 88 Total $ 2,023 $ 2,821 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes 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 believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain income tax positions have been recorded pursuant to this guidance. The Company’s tax years since 2016 remain subject to examination by federal, state and foreign tax authorities. |
Description of Business and S_2
Description of Business and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Financial Statement Estimates | Financial Statement Estimates — The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying 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 and the COVID-19 pandemic has increased the level of judgment used by management in developing these estimates and assumptions. The COVID-19 pandemic continues to rapidly evolve and the ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. 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 and gross-to-net adjustments, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitment, milestone rights liability, stock-based compensation and the determination of the provision for income taxes and corresponding deferred tax assets and liabilities, and the valuation allowance recorded against net deferred tax assets. |
Business | Business — MannKind is a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. The Company’s lead product is Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, which was approved by the U.S. Food and Drug Administration (“FDA”) in June 2014. Since September 2018, the Company has been collaborating with United Therapeutics to develop an inhaled formulation of treprostinil, known as Tyvaso DPI. In April 2021, United Therapeutics submitted a new drug application (“NDA”) to the FDA seeking approval of Tyvaso DPI. |
Basis of Presentation | Basis of Presentation — The condensed consolidated financial statements have been prepared in accordance with GAAP. The Company is not currently profitable and has rarely generated positive net cash flow from operations. In addition, the Company expects to continue to incur significant expenditures for the foreseeable future in support of its manufacturing operations, sales and marketing costs for Afrezza, and development of other product candidates in the Company’s pipeline. As of June 30, 2021, the Company had capital resources of $62.5 million in cash and cash equivalents, $100.0 million in short-term investments, $39.0 million in long-term investments, an accumulated deficit of $3.1 billion and total principal amount of outstanding borrowings of $293.3 million. In August 2019, the Company and its wholly owned subsidiary, MannKind LLC, entered into a credit and security agreement with MidCap Financial Trust (as amended, the “MidCap credit facility”). The MidCap Credit Facility currently provides a secured term loan facility with a potential aggregate principal amount of up to $110.0 million, leaving a balance of $50.0 million outstanding as of December 31, 2020. In April 2021, $10.0 million of the outstanding principal amount was repaid leaving a balance of $40.0 million at June 30, 2021. See Note 6 – Borrowings The Company believes its resources will be sufficient to fund its operations for the next twelve months from the date of issuance of these condensed consolidated financial statements. Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported condensed consolidated balance sheets or statements of operations. An adjustment has been made to the condensed consolidated statements of cash flows for the six months ended June 30, 2020 to combine payment of employment taxes related to vested restricted stock units and exercise of stock options in the cash flows from financing activities. These changes in classification do not affect previously reported cash flows from operating or investing activities. |
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. |
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. |
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”) Revenue from Contracts with Customers , At contract inception, once the contract is determined to be within the scope of Topic 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 and specialty pharmacies and (ii) collaboration arrangements. |
Revenue Recognition - Net Revenue - Commercial Product Sales | Revenue Recognition – Net Revenue – Commercial Product Sales – The Company sells Afrezza to a limited number of wholesale distributors and specialty pharmacies 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 pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at delivery for wholesale distributors and generally at delivery for specialty pharmacies. Product revenues are recorded net of applicable reserves, including discounts, allowances, rebates, returns and other incentives. See Reserves for Variable Consideration below. Free Goods Program – From time to time, the Company offers programs to potential new patients that allow them to obtain free goods (prescription fills) from a pharmacy. T he Company excludes such amounts related to these programs from both gross and net revenue. The cost of product associated with the free goods program is recognized as cost of goods sold in the condensed consolidated statements of operations. Reserves for Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payers, and other indirect customers relating to the Company’s sale of its products. These reserves, as further detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Significant judgments are required in making these estimates. Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted in accordance with the expected value method in Topic 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 estimates detailed below as of June 30, 2021 and, therefore, the transaction price was not reduced further during the six months ended June 30, 2021. 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 — commercial product sales and earnings in the period such variances become known. Significant judgment is required in estimating gross-to-net adjustments considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix, current contract prices under applicable programs, unbilled claims, processing time lags and inventory levels in the distribution channel. Trade Discounts and Allowances — The Company generally provides Customers with discounts which include incentives, such as prompt pay discounts, that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and as a reduction to accounts receivable, net. Product Returns — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending 12 months after its expiration date , which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company’s current return reserve percentage is estimated to be in the single-digits. Adjustments to the returns reserve have been made in the past and may be necessary in the future based on revised estimates to our assumptions. Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product 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 Medicare, 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 product that has 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 prescription drug 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 product that has 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 manufacturing commercial 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. 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 7 – . 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. 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 collaborative agreements, for accounting purposes, represent contracts with customers and therefore are not subject to accounting literature on collaborative agreements. The Company grants licenses to its intellectual property, supplies raw materials 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. The Company does not develop assets jointly with collaboration partners, and does not share in significant risks of their development or commercialization activities. Accordingly, the Company concluded that its collaborative agreements must generally be accounted for pursuant to Topic 606, Revenue from Contracts with Customers. 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. Rather, the Company evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts. The Company concluded there is no material right in these options. The Company follows detailed accounting guidance in measuring revenue and certain judgments affect the application of its revenue policy. For example, in connection with its existing collaboration agreements, the Company has recorded on its condensed consolidated balance sheets short-term and long-term deferred revenue based on its best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on the Company’s current project development plan and, if the development plan should change in the future, the Company may recognize a different amount of deferred revenue over the next 12-month period. |
Milestone Payments | Milestone Payments — At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment. |
PPP Loan | PPP loan — On April 10, 2020, the Company received the proceeds from a loan in the amount of approximately $4.9 million (the “PPP loan”) from JPMorgan Chase Bank, N.A., as lender, pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The Company accounted for the PPP loan as a financial liability in accordance with ASC Topic 470, . Accordingly, the PPP loan was recognized as current and long-term debt in the Company’s consolidated balance sheets and is included as PPP loan — current and PPP loan — long term. In addition, a amount of accrued interest is included in accrued expenses and other current liabilities. On July 28, 2021, the Company received notification from the U.S. Small Business Administration (“SBA”) that the full principal amount of the PPP loan was forgiven. See Note 6 – for additional information. |
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 significant 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. The cost of goods sold excludes the cost of insulin purchased under our 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 2015. |
Cash and Cash Equivalents and Restricted Cash | Cash and 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, 2021 and December 31, 2020, cash equivalents were comprised of money market accounts with 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. The Company presents amounts of restricted cash that will be available for use within 12 months of the reporting date as restricted cash in current assets. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported on the condensed consolidated balance sheets that sum to amounts reported on the condensed consolidated statements of cash flows (in thousands): June 30, 2021 December 31, 2020 June 30, 2020 Cash and cash equivalents $ 62,522 $ 67,005 $ 63,222 Restricted cash — 158 316 Total cash, cash equivalents, and restricted cash $ 62,522 $ 67,163 $ 63,538 |
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. For the three and six months ended June 30, 2021, the Company held short-term and long-term investments of debt securities, including commercial paper and bonds. The Company intends to hold its investments until maturity and are therefore stated at amortized cost. Those 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 our condensed consolidated balance sheets. The amortization of the Company’s investments is recognized as interest expense in the condensed consolidated statements of operations and was approximately $0.1 million for the three and six months ended June 30, 2021. There was no such amortization for the three or six months ended June 30, 2020. |
Available-for-Sale Investment | Available-for-Sale Investment — In June 2021, the Company invested $3.0 million in Thirona Bio, Inc. (“Thirona”) and received a $3.0 million convertible promissory note (the “Thirona convertible note”). Unless earlier converted into conversion shares pursuant to the note purchase agreement, the principal and accrued interest shall be due and payable by Thirona on demand by the Company at any time after the maturity date of December 2022. Interest shall accrue at a rate of 6% per annum. The Thirona convertible note is a general unsecured obligation of Thirona. The Thirona convertible note is classified as an available-for-sale security and is included in other assets in the condensed consolidated balance sheet. Available-for-sale investments are subsequently measured at fair value. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income until realized. The Company determines fair value of its available-for-sale investments using level 3 inputs. As of June 30, 2021, the Company evaluated the fair value of its investment in Thirona and determined that the fair value approximates the carrying value of $3.0 million. In June 2021, the Company and Thirona also entered into a collaboration agreement to develop a compound for the treatment of fibrotic lung diseases. See Note 7 – for additional information. |
Concentration of Credit Risk | Concentration of Credit Risk — Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents and investments. Cash and cash equivalents are held in high credit quality institutions. Cash equivalents consist of interest-bearing money market accounts. Investments generally consist 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 Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for doubtful accounts 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 doubtful accounts. 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 regulatory approval of the new supplier and the improved manufacturing process. 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 achieving regulatory approvals for the Company’s manufacturing process, feedback from 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 regulatory approval 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 approval date of the new raw material. If management is aware of any specific material risks or contingencies other than the normal regulatory review and approval 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 a research and development expense in the period incurred. |
Inventories | Inventories — Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company’s products based on management’s judgment that future economic benefits are expected to be realized; otherwise, such costs are expensed as incurred as cost of goods sold. The Company 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. |
Impairment of Long-Lived Assets | Impairment of Long-Lived 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. In August 2019, the Company recorded a $1.5 million commitment asset and a $0.4 million other asset for deferred debt issuance costs related to the future funding commitments of the MidCap Credit Facility. A quarterly assessment was performed to determine if the Company was on target to achieve certain required milestone conditions in order for the Company to access further borrowings under the MidCap credit facility . The Company determined that such milestone conditions related to Afrezza trailing net revenue we re unlikely to be achieved. As a result, a n asset impairment of $ million was recognized during the six months ended June 30 , 2020 and is reflected in the Company’s condensed consolidated statement s of operations . S ee Note 6 – Borrowings for further information on the MidCap credit facility . |
Recognized Loss on Purchase Commitments | Recognized Loss on Purchase Commitments — The Company assesses whether losses on long-term purchase commitments should be accrued. Losses that are expected to arise from firm, non-cancellable, commitments for the future purchases are recognized unless recoverable. When making the assessment, the Company also considers whether it is able to renegotiate with its vendors. The recognized loss on purchase commitments is reduced as inventory items are received. If, subsequent to an accrual, a purchase commitment is successfully renegotiated, the gain is recognized in the Company’s condensed consolidated statements of operations. The liability balance of the recognized loss on insulin purchase commitments was $88.7 million and $95.3 million as of June 30, 2021 and December 31, 2020, respectively. No new contracts were identified in 2020 or in the first six months of 2021 that required a new loss on purchase commitment accrual. |
Milestone Rights Liability | Milestone Rights Liability — On July 1, 2013, in conjunction with the execution of a financing facility with Deerfield Private Design Fund II L.P. and Deerfield Private Design International I L.P. , the Company issued to Deerfield Private Design Fund II, L.P. and Horizon Santé FLML SÁRL (the “Milestone Purchasers”) certain rights to receive payments of up to $90.0 million, of which $65.0 million remains payable as of June 30, 2021 upon the occurrence of specified strategic and sales milestones, including the achievement of specified net sales figures (the “Milestone Rights”). The Company analyzed the Milestone Rights and determined that they did not meet the definition of a freestanding derivative. Since the Company has not elected to apply the fair value option to the Milestone Rights, the Company recorded them at their estimated initial fair value and accounted for the Milestone Rights as a liability. The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones and discounted to present value using a selected market discount rate. The expected timing and probability of achieving the milestones was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The Milestone Rights liability will be remeasured as the specified milestone events are achieved. Specifically, as each milestone event is achieved, the portion of the initially recorded Milestone Rights liability that pertains to the milestone event being achieved, will be remeasured to the amount of the specified related milestone payment. The resulting change in the balance of the Milestone Rights liability due to remeasurement will be recorded in the Company’s consolidated statements of operations as interest expense. Furthermore, the Milestone Rights liability will be reduced upon the settlement of each milestone payment. As a result, each milestone payment would be effectively allocated between a reduction of the recorded Milestone Rights liability and an expense representing a return on a portion of the Milestone Rights liability paid to the investor for the achievement of the related milestone event (see Note 6 – Borrowings |
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. 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 stock options, RSUs, performance-based non-qualified stock options awards (“PNQs”), restricted stock units with market conditions (“Market RSUs”) 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. 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. 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. |
Clinical Trial Expenses | Clinical Trial Expenses — Clinical trial expenses, which are primarily reflected in research and development expenses in the condensed consolidated statements of operations, result from obligations under contracts with vendors, consultants and clinical site agreements in addition to internal costs associated with conducting clinical trials. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards — In August 2020, the FASB issued ASU 2020-06, , which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The Company early adopted this standard as of January 1, 2021. The adoption of this standard did not have a material impact on the Company's condensed consolidated financial statements. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards — From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (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, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported on the condensed consolidated balance sheets that sum to amounts reported on the condensed consolidated statements of cash flows (in thousands): June 30, 2021 December 31, 2020 June 30, 2020 Cash and cash equivalents $ 62,522 $ 67,005 $ 63,222 Restricted cash — 158 316 Total cash, cash equivalents, and restricted cash $ 62,522 $ 67,163 $ 63,538 |
Accounts Receivable (Tables)
Accounts Receivable (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Receivables [Abstract] | |
Schedule of Accounts Receivable, Net | Accounts receivable, net consists of the following (in thousands): |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventories consist of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 2,479 $ 1,393 Work-in-process 3,095 2,484 Finished goods 1,908 1,096 Total inventory $ 7,482 $ 4,973 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment consists of the following (in thousands): Estimated Useful Life (Years) June 30, 2021 December 31, 2020 Land — $ 875 $ 875 Buildings 39-40 17,389 17,389 Building improvements 5-40 37,717 37,543 Machinery and equipment 3-15 55,081 55,054 Furniture, fixtures and office equipment 5-10 3,004 3,004 Computer equipment and software 3 8,319 8,319 Construction in progress — 3,072 503 125,457 122,687 Less accumulated depreciation (97,318 ) (96,820 ) Total property and equipment, net $ 28,139 $ 25,867 |
Depreciation Expense Related to Property and Equipment | Depreciation expense related to property and equipment for the three and six months ended June 30, 2021 and 2020 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Depreciation Expense $ 481 $ 448 $ 941 $ 891 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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, 2021 December 31, 2020 Salary and related expenses $ 10,318 $ 11,250 Discounts and allowances for commercial product sales 4,035 3,688 Accrued interest 2,132 519 Deferred lease liability 1,351 1,422 Milestone rights liability — current 1,088 1,337 Danbury facility buildout 1,055 — Professional fees 521 533 Sales and marketing services 347 99 Other 1,559 859 Total accrued expenses and other current liabilities $ 22,406 $ 19,707 |
Borrowings (Tables)
Borrowings (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Carrying Amount of Principal Borrowings | Carrying amount of principal borrowings consist of the following (in thousands): June 30, 2021 December 31, 2020 Senior convertible notes $ 223,217 $ — MidCap credit facility 38,614 49,335 Mann Group promissory notes (1) 18,425 63,027 PPP loan 4,873 4,873 2024 convertible notes — 5,000 Total debt — net carrying amount $ 285,129 $ 122,235 ___________________ (1) The amendment to the Mann Group convertible note resulted in a substantial premium of $22.1 million based on the fair value post modification, which contributed to the loss on extinguishment in the condensed consolidated statement of operations for the three and six months ended June 30, 2021 and was recognized as additional paid-in capital in the condensed consolidated balance sheet as of June 30, 2021. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company. |
Schedule of Line of Credit Facility Debt and Key Terms | The following table provides a summary of the Company’s debt and key terms as of June 30, 2021: Amount Due Terms June 30, 2021 December 31, 2020 Annual Interest Rate Maturity Date Conversion Price Senior convertible notes $230.0 million $ — 2.50% March 2026 $5.21 per share MidCap credit facility (1) $40.0 million $50.0 million one-month LIBOR (1% floor) plus 6.25% (1 ) August 2025 (1 ) N/A Mann Group convertible note $18.4 million (plus $0.2 million accrued interest paid-in-kind) $28.0 million (plus $0.6 million accrued interest paid-in-kind) 2.50% (2 ) December 2025 (2 ) $2.50 per share Mann Group non-convertible note (3) $ — $35.1 million (plus $3.6 million accrued interest paid-in-kind) 7.00% November 2024 N/A PPP loan (4) $4.9 million $4.9 million 0.98% April 2022 N/A 2024 convertible notes (5) $ — $5.0 million 5.75% November 2024 $3.00 per share ____________________ (1) In April 2021, the Company prepaid $10.0 million principal balance and amended the MidCap credit facility. The interest rate prior to the amendment was one-month LIBOR (2% floor) plus 6.75% and the maturity date was in August 2024. (2) In April 2021, the Mann Group convertible note was amended. The interest rate prior to the amendment was 7.00% and the maturity date was in November 2024. (3) In April 2021, the Company prepaid $35.1 million principal balance as well as accrued unpaid interest. (4) In July 2021, the Company received full forgiveness from the SBA for the $4.9 million principal balance of the PPP loan. (5) In February 2021, the $5.0 million principal balance was converted into 1,666,667 shares of the Company’s common stock. |
Schedule of Maturities of Our Borrowings | The maturities of our borrowings as of June 30, 2021 are as follows (in thousands): Amounts 2021 $ 4,061 2022 812 2023 6,667 2024 38,425 Thereafter 243,333 Total principal payments 293,298 Discount (1,386 ) Debt issuance cost (6,783 ) Total debt — net carrying amount $ 285,129 |
Schedule of Amortization of Debt Premium and Accretion of Debt Discount and Debt Issuance Cost | Amortization of debt discount and debt issuance cost related to all borrowings for the three and six months ended June 30, 2021 and 2020 were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Amortization of debt discount $ 86 $ 90 $ 146 $ 179 Amortization of debt issuance cost 363 27 488 55 |
Collaboration, Licensing and _2
Collaboration, Licensing and Other Arrangements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Revenue from Collaboration and Services | Revenue from collaborations and services for the three and six months ended June 30, 2021 and 2020 are as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 UT License Agreement $ 12,163 $ 7,978 $ 21,163 $ 15,956 Vertice Pharma Co-Promotion Agreement 856 — 1,147 — Receptor CLA 165 63 175 125 Cipla License and Distribution Agreement 37 35 73 72 Other 83 — 83 — UT Research Agreement — 53 — 211 Total revenue from collaborations and services $ 13,304 $ 8,129 $ 22,641 $ 16,364 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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, 2021 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (1) $ 223.2 $ 257.0 $ 257.0 MidCap credit facility (2) 38.6 40.5 40.5 Mann Group convertible notes (3) 18.4 44.9 44.9 PPP loan (4) 4.9 4.8 4.8 Milestone rights (5) 5.9 15.0 15.0 ____________________ (1) Fair value determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 12%, volatility of 96% and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2% would result in a fair value of $245.4 million and $269.8 million, respectively. (2) Fair value determined by applying a discounted cash flow analysis with a hypothetical yield of 10%. A change in yield of + or – 2% would result in a fair value of $38.5 million and $42.7 million, respectively. (3) The April 2021 amendment to the Mann Group convertible note resulted in a substantial premium of $22.1 million based on the fair value post modification which was recognized as additional paid-in capital in the condensed consolidated balance sheet as of June 30, 2021. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company. The fair value assessed as of June 30, 2021 was determined by applying a discounted cash flow analysis with a hypothetical yield of 12% and volatility of 96% 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 $43.9 million and $45.9 million, respectively. (4) Fair value determined by applying a discounted cash flow analysis with a hypothetical yield of %. A change in yield of + or – 2 % would result in a fair value of $ 4.7 million and $ 4.8 million, respectively. (5) Fair value determined by applying a Monte Carlo simulation. December 31, 2020 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: (1) MidCap credit facility $ 49.3 $ 55.4 $ 55.4 Mann Group promissory notes (2) 63.0 78.9 78.9 2024 convertible notes 5.0 7.0 7.0 PPP loan 4.9 4.7 4.7 Milestone rights 7.3 19.8 19.8 ____________________ (1) Fair value measurements were based on a discounted cash flow model, except for the Milestone rights for which a Monte Carlo simulation was applied. (2) Mann Group promissory notes consisted of the following carrying values and fair values: Mann Group convertible notes carrying value of $28.0 million and fair value of $52.2 million. Mann Group non-convertible notes carrying value of $35.1 million and fair value of $26.7 million. |
Earnings Per Common Share ("E_2
Earnings Per Common Share ("EPS") (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
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 Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 EPS — basic and diluted: Net loss (numerator) $ (35,523 ) $ (10,252 ) $ (48,439 ) $ (19,574 ) Weighted average common shares (denominator) 249,295 213,880 247,970 212,943 Net loss per share $ (0.14 ) $ (0.05 ) $ (0.20 ) $ (0.09 ) |
Potential Dilutive Securities Outstanding that are Considered Antidilutive | Potentially dilutive securities outstanding that are considered antidilutive are summarized as follows (in shares): Six Months Ended June 30, 2021 2020 Senior convertible notes 44,120,463 — Mann Group convertible notes 7,370,000 14,000,000 Warrants associated with MidCap credit facility 1,283,467 1,171,614 Common stock options and PNQs 11,092,080 13,197,927 RSUs and Market RSUs (1) 7,986,898 2,501,713 Employee stock purchase plan 250,000 276,154 2024 convertible notes — 1,666,667 Common stock warrants — 31,851 Total shares 72,102,908 32,845,926 ____________________ (1) Market RSUs are included at the maximum share delivery percentage. |
Stock-Based Compensation Expe_2
Stock-Based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Employee Awards and Non-employee Director Award Plan Activity | During the six months ended June 30, 2021, the Company granted the following awards: Three Months Ended Three Months Ended Six Months Ended March 31, 2021 June 30, 2021 June 30, 2021 Employee awards: RSUs 370,137 (1) 1,476,059 (2) 1,846,196 Market RSUs — 918,775 (3) 918,775 Non-employee director RSUs — 316,232 (4) 316,232 Total awards 370,137 2,711,066 3,081,203 ____________________ (1) RSUs had a weighted average (2) RSUs had a weighted average grant (3) Market RSUs had a grant date fair value th th th th th (4) RSUs had a weighted average grant date fair value |
Stock Based Compensation Expense Recognized in Condensed Consolidated Statements of Operations | Total stock-based compensation expense recognized in the condensed consolidated statements of operations for the three months ended June 30, 2021 and 2020 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 RSUs and options $ 3,819 $ 2,122 $ 5,625 $ 3,188 Employee stock purchase plan 107 63 236 125 Total stock compensation expense $ 3,926 $ 2,185 $ 5,861 $ 3,313 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Remaining Purchase Requirements | In May 2021, the Company and Amphastar amended the Insulin Supply Agreement to extend the term and restructure the annual purchase commitments. In connection with the amendment, the Company agreed to pay $2.0 million of amendment fees, which were recognized in cost of goods sold for the three and six months ended June 30, 2021. The remaining purchase commitments as of June 30, 2021 and March 31, 2021 (pre-amendment) were as follows: June 30, 2021 March 31, 2021 2021 € 2.0 million € 7.0 million 2022 € 5.4 million € 8.5 million 2023 € 8.7 million € 10.9 million 2024 € 14.6 million € 14.6 million 2025 € 15.5 million € 15.5 million 2026 € 19.4 million € 19.4 million 2027 € 9.2 million € — |
Summary of Lease Information | Lease information is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease costs $ 340 $ 352 $ 685 $ 703 Variable lease costs 114 79 231 180 Cash paid 454 431 916 883 |
Schedule of Lease Term and Discount Rate | June 30, 2021 December 31, 2020 Weighted average remaining lease term (in years) 1.5 1.9 Weighted average discount rate 7.3 % 7.5 % |
Schedule of Future Minimum Office And Vehicle Lease Payments | Future minimum office and vehicle lease payments as of June 30, 2021 and December 31, 2020, are as follows (in thousands): June 30, 2021 December 31, 2020 2021 $ 722 $ 1,494 2022 1,213 1,239 2023 88 88 Total $ 2,023 $ 2,821 |
Description of Business and S_4
Description of Business and Significant Accounting Policies - Additional Information (Detail) | Apr. 22, 2021USD ($) | Apr. 10, 2020USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)SegmentContract | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Aug. 31, 2019USD ($) | Jul. 01, 2013USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Accumulated deficit | $ (3,097,582,000) | $ (3,097,582,000) | $ (3,097,582,000) | $ (3,049,143,000) | ||||||||
Principal amount | 293,300,000 | 293,300,000 | 293,300,000 | |||||||||
Cash and cash equivalents | 62,522,000 | 62,522,000 | $ 63,222,000 | 62,522,000 | $ 63,222,000 | 67,005,000 | ||||||
Short-term investments | 99,970,000 | 99,970,000 | 99,970,000 | |||||||||
Long-term investments | 38,950,000 | 38,950,000 | $ 38,950,000 | |||||||||
Debt issuance amount | $ 230,000,000 | |||||||||||
Debt issuance percentage | 2.50% | |||||||||||
Number of operating segment | Segment | 1 | |||||||||||
Proceeds from loans | 4,873,000 | |||||||||||
Accretion or amortization | 100,000 | $ 0 | $ 100,000 | 0 | ||||||||
Allowance for credit losses on held-to-maturity securities | $ 0 | $ 0 | $ 0 | |||||||||
ASU 2020-06 | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Change in accounting principle accounting standards update adopted | true | true | true | |||||||||
Change in accounting principle accounting standards update adoption date | Jan. 1, 2021 | Jan. 1, 2021 | Jan. 1, 2021 | |||||||||
Change in accounting principle accounting standards update immaterial effect | true | true | true | |||||||||
Change in accounting principle accounting standards update early adoption | true | true | true | |||||||||
Commitment Asset | Other Expense | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Asset impairment | $ 1,900,000 | |||||||||||
Paycheck Protection Program Loan, CARES Act | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Principal amount | [1] | $ 4,900,000 | $ 4,900,000 | $ 4,900,000 | 4,900,000 | |||||||
Proceeds from loans | $ 4,900,000 | |||||||||||
Convertible Promissory Note | Thirona Bio, Inc. | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Investment securities | 3,000 | $ 3,000 | $ 3,000 | |||||||||
Proceeds from investment securities | $ 3,000 | |||||||||||
Maturity date | 2022-12 | |||||||||||
Interest rate | 6.00% | 6.00% | 6.00% | |||||||||
Insulin | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Loss on purchase commitments | $ 88,700,000 | $ 88,700,000 | $ 88,700,000 | 95,300,000 | ||||||||
Loss on purchase commitments, number of new contracts recognized | Contract | 0 | |||||||||||
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 | |||||||||||
MidCap Credit Facility | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Principal amount | [2] | 40,000,000 | 40,000,000 | $ 40,000,000 | 50,000,000 | |||||||
Principal amount | $ 110,000,000 | |||||||||||
Amount outstanding | 40,000,000 | 40,000,000 | 40,000,000 | $ 50,000,000 | ||||||||
Principal prepayment against outstanding term loans | $ 10,000,000 | |||||||||||
Commitment asset | 1,500,000 | |||||||||||
Other asset | $ 400,000 | |||||||||||
Milestone Rights Liability | Deerfield | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Contingent liability remain payable | $ 65,000,000 | $ 65,000,000 | $ 65,000,000 | |||||||||
Milestone Rights Liability | Maximum | Deerfield | ||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||||||||
Contingent liability for milestone payments | $ 90,000,000 | |||||||||||
[1] | In July 2021, the Company received full forgiveness from the SBA for the $4.9 million principal balance of the PPP loan. | |||||||||||
[2] | In April 2021, the Company prepaid $10.0 million principal balance and amended the MidCap credit facility. The interest rate prior to the amendment was one-month LIBOR (2% floor) plus 6.75% and the maturity date was in August 2024. |
Description of Business and S_5
Description of Business and Significant Accounting Policies - Additional Information (Detail 1) | Jun. 30, 2021 |
Collaborations and services | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2020-10-01 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Remaining performance obligation, expected timing of satisfaction, period | 12 months |
Schedule of Reconciliation of C
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 62,522 | $ 67,005 | $ 63,222 | |
Restricted cash | 158 | 316 | ||
Total cash, cash equivalents, and restricted cash | $ 62,522 | $ 67,163 | $ 63,538 | $ 30,222 |
Schedule of Accounts Receivable
Schedule of Accounts Receivable, Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accounts Receivable [Line Items] | ||
Total accounts receivable, net | $ 6,305 | $ 4,218 |
Commercial product sales | ||
Accounts Receivable [Line Items] | ||
Accounts receivable, gross | 8,467 | 8,090 |
Wholesaler distribution fees and prompt pay discounts | (1,335) | (1,205) |
Reserve for returns | (2,928) | (2,667) |
Total accounts receivable, net | 4,204 | $ 4,218 |
Collaborations and services | ||
Accounts Receivable [Line Items] | ||
Total accounts receivable, net | $ 2,101 |
Accounts Receivable - Additiona
Accounts Receivable - Additional Information (Detail) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021Distributor | |
Accounts Receivable [Line Items] | ||
Number of wholesale distributors | 3 | |
Percentage of gross sales from major wholesale distributors | 82.00% | 82.00% |
Commercial product sales | ||
Accounts Receivable [Line Items] | ||
Percentage of accounts receivable from major wholesale distributors | 88.00% | 88.00% |
Inventories - Components of Inv
Inventories - Components of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 2,479 | $ 1,393 |
Work-in-process | 3,095 | 2,484 |
Finished goods | 1,908 | 1,096 |
Total inventory | $ 7,482 | $ 4,973 |
Inventories - Additional Inform
Inventories - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Inventory [Line Items] | ||||
Inventory write-off | $ 0 | $ 0 | $ 496,000 | |
Pre-launch Inventory | ||||
Inventory [Line Items] | ||||
Raw materials inventory | $ 800,000 | $ 800,000 | $ 800,000 |
Property and Equipment, Net (De
Property and Equipment, Net (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | ||
Property and equipment - gross | $ 125,457 | $ 122,687 |
Less accumulated depreciation | (97,318) | (96,820) |
Total property and equipment, net | 28,139 | 25,867 |
Land | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment - gross | 875 | 875 |
Buildings | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment - gross | $ 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] | ||
Property and equipment - gross | $ 37,717 | 37,543 |
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] | ||
Property and equipment - gross | $ 55,081 | 55,054 |
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] | ||
Property and equipment - gross | $ 3,004 | 3,004 |
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] | ||
Property and equipment - gross | $ 8,319 | 8,319 |
Estimated Useful Life (Years) | 3 years | |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment - gross | $ 3,072 | $ 503 |
Depreciation Expense Related to
Depreciation Expense Related to Property and Equipment (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation Expense | $ 481 | $ 448 | $ 941 | $ 891 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Salary and related expenses | $ 10,318 | $ 11,250 |
Discounts and allowances for commercial product sales | 4,035 | 3,688 |
Accrued interest | 2,132 | 519 |
Deferred lease liability | 1,351 | 1,422 |
Milestone rights liability — current | 1,088 | 1,337 |
Danbury facility buildout | 1,055 | |
Professional fees | 521 | 533 |
Sales and marketing services | 347 | 99 |
Other | 1,559 | 859 |
Total accrued expenses and other current liabilities | $ 22,406 | $ 19,707 |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities - Additional Information (Detail) $ in Millions | Jun. 30, 2021USD ($) |
Payables And Accruals [Abstract] | |
Deferred social security taxes, CARES Act | $ 1 |
Borrowings - Summary of Carryin
Borrowings - Summary of Carrying Amount of Principal Borrowings (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | |||
Senior convertible notes | $ 223,217 | ||
Mann Group promissory notes | [1] | 18,425 | $ 63,027 |
Total debt — net carrying amount | 285,129 | 122,235 | |
MidCap Credit Facility | |||
Debt Instrument [Line Items] | |||
Credit Facility | 38,614 | 49,335 | |
PPP Loan | |||
Debt Instrument [Line Items] | |||
PPP loan | $ 4,873 | 4,873 | |
2024 Convertible Notes | |||
Debt Instrument [Line Items] | |||
Senior convertible notes | $ 5,000 | ||
[1] | The amendment to the Mann Group convertible note resulted in a substantial premium of $22.1 million based on the fair value post modification, which contributed to the loss on extinguishment in the condensed consolidated statement of operations for the three and six months ended June 30, 2021 and was recognized as additional paid-in capital in the condensed consolidated balance sheet as of June 30, 2021. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company. |
Borrowings - Summary of Carry_2
Borrowings - Summary of Carrying Amount of Principal Borrowings (Parenthetical) (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021USD ($) | Jun. 30, 2021USD ($) | |
Debt Instrument [Line Items] | ||
Loss on extinguishment of debt | $ 22,130 | $ 22,130 |
Promissory Notes | Mann Group | ||
Debt Instrument [Line Items] | ||
Debt premium recognized in additional paid-in capital | 22,100 | 22,100 |
Loss on extinguishment of debt | $ 22,100 | $ 22,100 |
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, 2021 | Mar. 04, 2021 | Dec. 31, 2020 | Apr. 10, 2020 | |||
Debt Instrument [Line Items] | ||||||
Amount Due | $ 293.3 | |||||
Senior Convertible Notes | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | $ 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 | [1] | $ 40 | $ 50 | |||
Maturity date | [1] | 2025-08 | ||||
MidCap Credit Facility | LIBOR | ||||||
Debt Instrument [Line Items] | ||||||
Annual interest rate | [1] | 6.25% | ||||
Interest rate floor | [1] | 1.00% | ||||
5.75% 2024 Convertible Note | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | [2] | 5 | ||||
Annual interest rate | [2] | 5.75% | ||||
Maturity date | [2] | 2024-11 | ||||
Conversion price | [2] | $ 3 | ||||
PPP Loan | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | [3] | $ 4.9 | 4.9 | |||
Annual interest rate | 0.98% | [3] | 0.98% | |||
Maturity date | [3] | 2022-04 | ||||
Mann Group | Convertible Promissory Note | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | $ 18.4 | 28 | ||||
Accrued interest paid-in-kind | $ 0.2 | 0.6 | ||||
Annual interest rate | [4] | 2.50% | ||||
Maturity date | [4] | 2025-12 | ||||
Conversion price | $ 2.50 | |||||
Mann Group | Non Convertible Promissory Note | ||||||
Debt Instrument [Line Items] | ||||||
Amount Due | [5] | 35.1 | ||||
Accrued interest paid-in-kind | [5] | $ 3.6 | ||||
Annual interest rate | [5] | 7.00% | ||||
Maturity date | [5] | 2024-11 | ||||
[1] | In April 2021, the Company prepaid $10.0 million principal balance and amended the MidCap credit facility. The interest rate prior to the amendment was one-month LIBOR (2% floor) plus 6.75% and the maturity date was in August 2024. | |||||
[2] | In February 2021, the $5.0 million principal balance was converted into 1,666,667 shares of the Company’s common stock. | |||||
[3] | In July 2021, the Company received full forgiveness from the SBA for the $4.9 million principal balance of the PPP loan. | |||||
[4] | In April 2021, the Mann Group convertible note was amended. The interest rate prior to the amendment was 7.00% and the maturity date was in November 2024. | |||||
[5] | In April 2021, the Company prepaid $35.1 million principal balance as well as accrued unpaid interest. |
Borrowings - Schedule of Line_2
Borrowings - Schedule of Line of Credit Facility Debt and Key Terms (Parenthetical) (Detail) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | ||||||
Jul. 31, 2021 | Apr. 30, 2021 | Mar. 31, 2021 | Feb. 28, 2021 | Jun. 30, 2021 | Apr. 10, 2020 | |||
Debt Instrument [Line Items] | ||||||||
Debt issuance amount | $ 230 | |||||||
Paycheck Protection Program Loan, CARES Act | ||||||||
Debt Instrument [Line Items] | ||||||||
Annual interest rate | 0.98% | [1] | 0.98% | |||||
Maturity date | [1] | 2022-04 | ||||||
Debt instrument , forgiveness amount received | $ 4.9 | |||||||
2024 Convertible Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Annual interest rate | [2] | 5.75% | ||||||
Maturity date | [2] | 2024-11 | ||||||
Debt issuance amount | $ 5 | |||||||
Conversion of debt shares issued | 1,666,667 | |||||||
MidCap Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment of principal balance | $ 10 | |||||||
Maturity date | [3] | 2025-08 | ||||||
MidCap Credit Facility | Prior To Midcap Credit Facility Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Maturity date | 2024-08 | |||||||
LIBOR | MidCap Credit Facility | ||||||||
Debt Instrument [Line Items] | ||||||||
Annual interest rate | [3] | 6.25% | ||||||
Interest rate floor | [3] | 1.00% | ||||||
LIBOR | MidCap Credit Facility | Prior To Midcap Credit Facility Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Annual interest rate | 2.00% | |||||||
Interest rate floor | 6.75% | |||||||
Mann Group | Non Convertible Promissory Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment of principal balance | $ 35.1 | |||||||
Annual interest rate | [4] | 7.00% | ||||||
Maturity date | [4] | 2024-11 | ||||||
Mann Group | Non Convertible Promissory Note | Prior to First Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Annual interest rate | 7.00% | |||||||
Maturity date | 2024-11 | |||||||
[1] | In July 2021, the Company received full forgiveness from the SBA for the $4.9 million principal balance of the PPP loan. | |||||||
[2] | In February 2021, the $5.0 million principal balance was converted into 1,666,667 shares of the Company’s common stock. | |||||||
[3] | In April 2021, the Company prepaid $10.0 million principal balance and amended the MidCap credit facility. The interest rate prior to the amendment was one-month LIBOR (2% floor) plus 6.75% and the maturity date was in August 2024. | |||||||
[4] | In April 2021, the Company prepaid $35.1 million principal balance as well as accrued unpaid interest. |
Borrowings - Schedule of Maturi
Borrowings - Schedule of Maturities of Our Borrowings (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
2021 | $ 4,061 | |
2022 | 812 | |
2023 | 6,667 | |
2024 | 38,425 | |
Thereafter | 243,333 | |
Total principal payments | 293,298 | |
Discount | (1,386) | |
Debt issuance cost | (6,783) | |
Total debt — net carrying amount | $ 285,129 | $ 122,235 |
Borrowings - Senior Convertible
Borrowings - Senior Convertible Notes - Additional Information (Detail) | Mar. 04, 2021USD ($)d$ / shares | Jun. 30, 2021USD ($)d$ / shares | Mar. 15, 2021USD ($) | Dec. 31, 2020$ / shares |
Debt Instrument [Line Items] | ||||
Principal amount | $ 293,300,000 | |||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | ||
Proceeds from offering after deducting initial purchasers discounts and commissions and estimated offering expenses payable | $ 230,000,000 | |||
Unamortized debt issuance cost | 6,783,000 | |||
Senior Convertible Notes | ||||
Debt Instrument [Line Items] | ||||
Principal amount | $ 230,000,000 | |||
Maturity date | Mar. 1, 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 | 130.00% | 130.00% | ||
Principal amount per share | $ / shares | $ 1,000 | $ 1,000 | ||
Measurement period percentage | 98.00% | |||
Conversion price | $ / shares | $ 5.21 | $ 5.21 | ||
Initial conversion price of premium percentage | 30.00% | |||
No of convertible shares | 191.8281 | |||
Redemption period start date | Mar. 6, 2024 | |||
Redemption price percentage | 100.00% | |||
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 Notes, at least $75.0 million aggregate principal amount of 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 | 100.00% | |||
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 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 | $ 6,800,000 | |||
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 | $ 200,000,000 | $ 30,000,000 |
Borrowings - MidCap Credit Faci
Borrowings - MidCap Credit Facility - Additional Information (Detail) | Apr. 22, 2021USD ($)Installment | Apr. 30, 2021USD ($) | Dec. 31, 2020USD ($)Installment$ / sharesshares | Nov. 30, 2020USD ($)Installment$ / shares | Aug. 31, 2020USD ($) | Dec. 31, 2019 | Aug. 31, 2019USD ($)Installment$ / sharesshares | Jun. 30, 2021USD ($) | Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($)$ / sharesshares | Mar. 31, 2021USD ($) | |
Debt Instrument [Line Items] | ||||||||||||
Loss on extinguishment of debt | $ 22,130,000 | $ 22,130,000 | ||||||||||
Unamortized debt discount | 1,386,000 | $ 1,386,000 | ||||||||||
MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Prepaid of borrowing | $ 10,000,000 | |||||||||||
Minimum cash covenant | $ 30,000,000 | $ 10,000,000 | ||||||||||
Debt payable number of equal monthly installments | Installment | 24 | |||||||||||
Debt instrument payment term description | Principal on each term loan advance under Tranche 1, Tranche 2 and, if applicable, Tranche 3 is payable in 24 equal monthly installments beginning September 1, 2023, until paid in full on August 1, 2025. | |||||||||||
Debt instrument minimum unrestricted cash and short-term investments | $ 90,000,000 | |||||||||||
Principal prepayment against outstanding term loans | $ 10,000,000 | |||||||||||
Original exit fee and prepayment penalties | 1,000,000 | $ 1,000,000 | ||||||||||
Unamortized debt discount | 400,000 | $ 400,000 | ||||||||||
Debt Instrument unamortized prepayment penalty. | $ 900,000 | $ 900,000 | ||||||||||
Interest on loans increased, percentage | 2.00% | |||||||||||
Term loan advance percentage of amount drawdown | 3.25% | |||||||||||
Exercise price of warrants | $ / shares | $ 2.91 | $ 1.11 | ||||||||||
MidCap Credit Facility | On or After April 23, 2022 Through and Including April 22, 2023 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Early termination fees, percentage | 2.00% | |||||||||||
MidCap Credit Facility | On or Prior to April 22, 2022 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Early termination fees, percentage | 3.00% | |||||||||||
MidCap Credit Facility | On or After April 23, 2023 Through Maturity Date | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Early termination fees, percentage | 1.00% | |||||||||||
MidCap Credit Facility | LIBOR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate floor | [1] | 1.00% | ||||||||||
MidCap Credit Facility | Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt Instrument Exit Fee Percentage | 6.00% | |||||||||||
MidCap Credit Facility | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt Instrument Exit Fee Percentage | 7.00% | |||||||||||
Tranche 1 | MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Advance of borrowing | $ 40,000,000 | $ 40,000,000 | ||||||||||
Minimum cash covenant | $ 40,000,000 | |||||||||||
Debt payable number of equal monthly installments | Installment | 24 | |||||||||||
Loss on extinguishment of debt | $ 200,000 | |||||||||||
Maturity date | Aug. 1, 2025 | |||||||||||
Annual interest rate | 8.25% | |||||||||||
Line of credit facility principal payment start date | Sep. 1, 2023 | |||||||||||
Warrants to purchase of common stock | shares | 1,171,614 | |||||||||||
Exercise price of warrants | $ / shares | $ 1.11 | |||||||||||
Tranche 1 | MidCap Credit Facility | LIBOR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate (LIBOR) | 6.25% | |||||||||||
Interest rate floor | 1.00% | |||||||||||
Tranche 2 | MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Advance of borrowing | 10,000,000 | |||||||||||
Amount available under credit facility | $ 10,000,000 | $ 10,000,000 | ||||||||||
Debt payable number of equal monthly installments | Installment | 24 | |||||||||||
Debt discount and a de minimis amount of debt issuance costs | $ 300,000 | |||||||||||
Maturity date | Aug. 1, 2025 | |||||||||||
Annual interest rate | 8.25% | 8.25% | ||||||||||
Line of credit facility principal payment start date | Sep. 1, 2023 | |||||||||||
Warrants to purchase of common stock | shares | 111,853 | 111,853 | ||||||||||
Exercise price of warrants | $ / shares | $ 2.91 | $ 2.91 | ||||||||||
Tranche 2 | MidCap Credit Facility | LIBOR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate (LIBOR) | 6.25% | |||||||||||
Interest rate floor | 1.00% | |||||||||||
Tranche 3 | MidCap Credit Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Amount available under credit facility | $ 60,000,000 | $ 60,000,000 | $ 25,000,000 | |||||||||
Debt payable number of equal monthly installments | Installment | 24 | |||||||||||
Debt instrument advance available date | Jun. 30, 2022 | |||||||||||
Debt instrument extended interest-only date | Sep. 1, 2023 | |||||||||||
Maturity date | Aug. 1, 2025 | |||||||||||
Debt instrument payment term description | On April 22, 2021, the Company entered into the seventh amendment of the MidCap credit facility, pursuant to which the parties agreed to, among other things, (i) increase the amount available under the third advance from $25.0 million to $60.0 million and extend the date through which the third advance is available to June 30, 2022, (ii) amend the conditions to the third advance of $60.0 million being available to draw, including certain milestone conditions associated with Tyvaso DPI, (iii) remove the Company’s obligation to issue a warrant to purchase shares of the Company’s common stock upon drawing down the third advance, (iv) extend the interest-only period until September 1, 2023 and extend the maturity date until August 1, 2025, (v) amend the financial covenant relating to trailing 12 month minimum Afrezza net revenue, (vi) decrease the minimum cash covenant, (vii) decrease the interest rate on any amounts outstanding, now or in the future, under the MidCap credit facility, (viii) permit the Company to make certain acquisitions, subject to requirements, and (ix) permit the Company to make investments of up to an additional $9.0 million so long as the Company has $90.0 million or more of unrestricted cash and short-term investments following such investment. | |||||||||||
Maximum value of additional investment limit | $ 9,000,000 | |||||||||||
Debt instrument minimum unrestricted cash and short-term investments | $ 90,000,000 | |||||||||||
Annual interest rate | 8.25% | |||||||||||
Line of credit facility principal payment start date | Sep. 1, 2023 | |||||||||||
Tranche 3 | MidCap Credit Facility | LIBOR | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate (LIBOR) | 6.25% | |||||||||||
Interest rate floor | 1.00% | |||||||||||
[1] | In April 2021, the Company prepaid $10.0 million principal balance and amended the MidCap credit facility. The interest rate prior to the amendment was one-month LIBOR (2% floor) plus 6.75% and the maturity date was in August 2024. |
Borrowings - Mann Group Promiss
Borrowings - Mann Group Promissory Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands | Apr. 22, 2021USD ($) | Mar. 31, 2021USD ($) | Aug. 31, 2019USD ($)$ / shares | Jun. 30, 2021USD ($)$ / shares | Mar. 31, 2021USD ($)shares | Dec. 31, 2020USD ($)shares | Jun. 30, 2021USD ($)$ / sharesshares | |
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 293,300 | $ 293,300 | ||||||
Loss on extinguishment of debt | 22,130 | 22,130 | ||||||
Debt issuance amount | $ 230,000 | |||||||
Mann Group | Convertible Promissory Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 18,400 | $ 28,000 | $ 18,400 | |||||
Senior notes, effective interest rate | [1] | 2.50% | 2.50% | |||||
Conversion price of shares | $ / shares | $ 2.50 | $ 2.50 | ||||||
Debt issuance amount | $ 9,600 | $ 7,000 | $ 9,600 | |||||
Conversion of notes to common shares, shares | shares | 4,000,000 | 2,800,000 | 4,000,000 | |||||
Repayments of debt | $ 35,100 | |||||||
Mann Group | Convertible Promissory Note | Accrued Interest | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt issuance amount | $ 3,000 | $ 400 | ||||||
Conversion of notes to common shares, shares | shares | 1,200,000 | |||||||
Mann Group | Promissory Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument fair value in excess of face amount | $ 18,400 | 18,400 | ||||||
Loss on extinguishment of debt | 22,100 | 22,100 | ||||||
Debt premium recognized in additional paid-in capital | $ 22,100 | $ 22,100 | ||||||
Mann Group | New Loan Arrangement | Convertible Promissory Note | ||||||||
Debt Instrument [Line Items] | ||||||||
No of convertible shares | 400 | |||||||
Principal amount per share | $ / shares | $ 1,000 | |||||||
Conversion price of shares | $ / shares | $ 2.50 | |||||||
Mann Group | New Loan Arrangement | Promissory Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Senior notes, effective interest rate | 2.50% | 7.00% | ||||||
Debt instrument payment term description | quarterly | |||||||
Debt instrument, date of first required interest payment | Oct. 1, 2019 | |||||||
Maturity date | Dec. 31, 2025 | Nov. 3, 2024 | ||||||
Mann Group | Privately Negotiated Exchange Agreement | Loan Arrangement | ||||||||
Debt Instrument [Line Items] | ||||||||
Common stock price per share | $ / shares | $ 2.50 | |||||||
Mann Group | Privately Negotiated Exchange Agreement | Loan Arrangement | Convertible Promissory Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 35,000 | |||||||
Mann Group | Privately Negotiated Exchange Agreement | Loan Arrangement | Non-Convertible Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal amount | $ 35,100 | |||||||
[1] | In April 2021, the Mann Group convertible note was amended. The interest rate prior to the amendment was 7.00% and the maturity date was in November 2024. |
Borrowings - PPP Loan - Additio
Borrowings - PPP Loan - Additional Information (Detail) - USD ($) $ in Thousands | Apr. 10, 2020 | Jun. 30, 2020 | Jun. 30, 2021 | [1] |
Debt Instrument [Line Items] | ||||
Proceeds from Paycheck Protection Program loan | $ 4,873 | |||
PPP Loan | ||||
Debt Instrument [Line Items] | ||||
Proceeds from Paycheck Protection Program loan | $ 4,900 | |||
Maturity date | Apr. 9, 2022 | |||
Annual interest rate | 0.98% | 0.98% | ||
[1] | In July 2021, the Company received full forgiveness from the SBA for the $4.9 million principal balance of the PPP loan. |
Borrowings - 2024 Convertible N
Borrowings - 2024 Convertible Notes - Additional Information (Detail) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | |||
Mar. 31, 2021USD ($) | Feb. 28, 2021USD ($)shares | Aug. 31, 2020$ / shares | Aug. 31, 2019 | Jun. 30, 2021 | |
Debt Instrument [Line Items] | |||||
Debt issuance amount | $ | $ 230 | ||||
2024 Convertible Notes | |||||
Debt Instrument [Line Items] | |||||
Senior notes, effective interest rate | 5.75% | ||||
Maturity date | 2024-11 | ||||
Debt instrument payment term description | The 2024 convertible notes accrued interest at the rate of 5.75% per year on the principal amount, payable semiannually in arrears on February 15 and August 15 of each year, beginning February 15, 2020, with interest accruing from August 6, 2019. Interest on the 2024 convertible notes was payable in cash or, at the option of the Company if certain conditions are 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 interest payment date. | ||||
No of convertible shares | 333.3333 | ||||
Principal amount per share | $ / shares | $ 1,000 | ||||
Conversion price | $ / shares | $ 3 | ||||
Debt issuance amount | $ | $ 5 | ||||
Conversion of debt shares issued | shares | 1,666,667 |
Borrowings - Schedule of Amorti
Borrowings - Schedule of Amortization of Debt Premium and Accretion of Debt Discount and Debt Issuance Cost (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Debt Disclosure [Abstract] | ||||
Amortization of debt discount | $ 86 | $ 90 | $ 146 | $ 179 |
Amortization of debt issuance cost | $ 363 | $ 27 | $ 488 | $ 55 |
Borrowings - Milestone Rights -
Borrowings - Milestone Rights - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Debt Disclosure [Abstract] | ||
Remaining milestone rights liability | $ 5.9 | $ 7.3 |
Payment for milestone liability | 5 | |
Milestone rights liability, current | $ 1.3 |
Schedule of Revenue from Collab
Schedule of Revenue from Collaborations and Services (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | $ 23,280 | $ 15,114 | $ 40,716 | $ 31,349 |
Collaborations and services | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 13,304 | 8,129 | 22,641 | 16,364 |
Collaborations and services | License Agreement | United Therapeutics Corporation | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 12,163 | 7,978 | 21,163 | 15,956 |
Collaborations and services | Co-Promotion Agreement | Vertice Pharma LLC | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 856 | 1,147 | ||
Collaborations and services | Collaboration and License Agreement | Receptor CLA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 165 | 63 | 175 | 125 |
Collaborations and services | License and Distribution Agreement | Cipla Ltd | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | 37 | 35 | 73 | 72 |
Collaborations and services | Research Agreement | United Therapeutics Corporation | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | $ 53 | $ 211 | ||
Collaborations and services | Other | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Total revenue from collaborations and services | $ 83 | $ 83 |
Collaboration, Licensing and _3
Collaboration, Licensing and Other Arrangements - Additional Information (Detail) - USD ($) | Jul. 01, 2021 | May 31, 2021 | Dec. 31, 2020 | Sep. 30, 2019 | May 31, 2018 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Nov. 30, 2020 | Oct. 31, 2018 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue - current | $ 33,275,000 | $ 20,126,000 | $ 20,126,000 | $ 33,275,000 | ||||||||
Revenue' collaborations and services | 23,280,000 | $ 15,114,000 | 40,716,000 | $ 31,349,000 | ||||||||
Deferred revenue - long term | 1,662,000 | 1,589,000 | 1,589,000 | 1,662,000 | ||||||||
Commercial product sales | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Revenue' collaborations and services | 9,976,000 | 6,985,000 | 18,075,000 | $ 14,985,000 | ||||||||
Collaboration and License Agreement | United Therapeutics Corporation | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Upfront payment received | $ 45,000,000 | |||||||||||
Milestone Payment Received | $ 12,500,000 | |||||||||||
Total transaction price | $ 50,200,000 | 50,900,000 | $ 50,900,000 | |||||||||
Increase in total consideration | $ 2,700,000 | |||||||||||
Revenue, performance obligation satisfied over time, method used, description | The Company determined that the Pre-Commercial Services and Next-gen R&D Services performance obligations will be satisfied over time using the input method based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. | |||||||||||
Revenue, performance obligation satisfied over time, method used, explanation | Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer. The Facility Expansion Services performance obligation would be recognized as control of manufactured products is transferred to the customer. | |||||||||||
Deferred revenue - current | 20,000,000 | $ 20,000,000 | ||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Equipment | Deposit from Customer | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Proceeds from related party | 5,300,000 | |||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Additional Clinical Supplies | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total transaction price | 700,000 | $ 700,000 | ||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | R&D Services | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total transaction price | 18,300,000 | |||||||||||
Revenue, performance obligation, expected timing of satisfaction, description | The R&D Services performance obligation was allocated a total of $18.3 million, which will be recognized on a ratable basis from May 2021 through October 2021; the estimated date when the performance obligation for the initial development services will be substantially completed. | |||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Pre-Commercial Services | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total transaction price | 4,600,000 | |||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Next-gen R&D Services | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total transaction price | 7,200,000 | |||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Facility Expansion Services | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total transaction price | $ 20,700,000 | |||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Clinical Supplies | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total transaction price | 105,800,000 | $ 105,800,000 | ||||||||||
Collaboration and License Agreement | United Therapeutics Corporation | Maximum | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Additional option exercise and development milestone payments to be receive | 40,000,000 | 40,000,000 | ||||||||||
Co-Promotion Agreement | Vertice Pharma LLC | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Total transaction price | 6,300,000 | 6,300,000 | ||||||||||
Co-Promotion Agreement | Other Assets | Vertice Pharma LLC | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Contract asset | 100,000 | 100,000 | ||||||||||
Amendment to Co Promotion Agreement | Vertice Pharma LLC | Subsequent Event | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Percentage of modification of previously fixed consideration | 50.00% | |||||||||||
Supply and Distribution Agreement | Commercial product sales | Biomm | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Revenue' collaborations and services | $ 700,000 | $ 200,000 | 0 | $ 0 | ||||||||
License and Distribution Agreement | Cipla Ltd | ||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue - current | 100,000 | 100,000 | ||||||||||
Marketing and distribution agreement date | 2018-05 | |||||||||||
Deferred revenue | 1,700,000 | 1,700,000 | ||||||||||
Deferred revenue - long term | $ 1,600,000 | $ 1,600,000 |
Collaboration, Licensing and _4
Collaboration, Licensing and Other Arrangements - Additional Information (Detail 1) - USD ($) $ in Millions | Jun. 30, 2021 | May 31, 2021 | May 31, 2018 |
Collaboration and License Agreement | United Therapeutics Corporation | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Deferred revenue - nonrefundable license fee | $ 50.9 | $ 50.2 | |
Collaboration and License Agreement | United Therapeutics Corporation | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2018-10-01 | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Deferred revenue recognition period | 39 months | ||
Co-Promotion Agreement | Vertice Pharma LLC | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Deferred revenue - nonrefundable license fee | $ 6.3 | ||
Co-Promotion Agreement | Vertice Pharma LLC | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2021-01-01 | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Deferred revenue recognition period | 2 years | ||
License and Distribution Agreement | Cipla Ltd | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2018-06-01 | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Deferred revenue recognition period | 15 years | ||
Deferred revenue - nonrefundable license fee | $ 2.2 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 |
Fair Value Of Financial Instruments [Line Items] | |||
Cash and cash equivalents | $ 62,522 | $ 67,005 | $ 63,222 |
Restricted cash | 158 | $ 316 | |
Short-term investments | 99,970 | ||
Long-term investments | 38,950 | ||
Money Market Funds | |||
Fair Value Of Financial Instruments [Line Items] | |||
Cash and cash equivalents | 62,500 | 67,000 | |
Restricted cash | $ 0 | $ 200 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Fair Value of Financial Instruments (Detail) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
MidCap Credit Facility | ||
Financial liabilities: | ||
Financial liabilities fair value | $ 40.5 | $ 55.4 |
Senior Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 257 | |
Mann Group Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 44.9 | 52.2 |
PPP Loan | ||
Financial liabilities: | ||
Financial liabilities fair value | 4.8 | 4.7 |
Milestone Rights Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 15 | 19.8 |
2024 Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 7 | |
Mann Group Promissory Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 78.9 | |
Carrying Value | MidCap Credit Facility | ||
Financial liabilities: | ||
Financial liabilities fair value | 38.6 | 49.3 |
Carrying Value | Senior Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 223.2 | |
Carrying Value | Mann Group Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 18.4 | 28 |
Carrying Value | PPP Loan | ||
Financial liabilities: | ||
Financial liabilities fair value | 4.9 | 4.9 |
Carrying Value | Milestone Rights Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 5.9 | 7.3 |
Carrying Value | 2024 Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 5 | |
Carrying Value | Mann Group Promissory Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 63 | |
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | MidCap Credit Facility | ||
Financial liabilities: | ||
Financial liabilities fair value | 40.5 | 55.4 |
Estimate of Fair Value Measurement | Senior Convertible Notes | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 257 | |
Estimate of Fair Value Measurement | Mann Group Convertible Notes | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 44.9 | |
Estimate of Fair Value Measurement | PPP Loan | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 4.8 | 4.7 |
Estimate of Fair Value Measurement | Milestone Rights Liability | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | $ 15 | 19.8 |
Estimate of Fair Value Measurement | 2024 Convertible Notes | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 7 | |
Estimate of Fair Value Measurement | Mann Group Promissory Notes | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | $ 78.9 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Fair Value of Financial Instruments (Parenthetical) (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021USD ($) | Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($) | |
Fair Value Of Financial Instruments [Line Items] | |||
Loss on extinguishment of debt | $ (22,130) | $ (22,130) | |
MidCap Credit Facility | |||
Fair Value Of Financial Instruments [Line Items] | |||
Note payable, percentage of hypothetical yield | 10 | 10 | |
Note payable, percentage of interest rate increases (decreases) | 2.00% | ||
Financial liabilities fair value | $ 40,500 | $ 40,500 | $ 55,400 |
MidCap Credit Facility | Carrying Value | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | 38,600 | 38,600 | 49,300 |
MidCap Credit Facility | Minimum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | 38,500 | 38,500 | |
MidCap Credit Facility | Maximum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 42,700 | $ 42,700 | |
Mann Group Convertible Notes | |||
Fair Value Of Financial Instruments [Line Items] | |||
Note payable, percentage of hypothetical yield | 12 | 12 | |
Note payable, percentage of interest rate increases (decreases) | 2.00% | ||
Loss on extinguishment of debt | $ (22,100) | ||
Substantial premium based on fair value post modification recognized as additional paid-in capital | $ 22,100 | $ 22,100 | |
Mann Group Convertible Notes | Volatility | |||
Fair Value Of Financial Instruments [Line Items] | |||
Note payable, percentage of volatility | 96 | 96 | |
Mann Group Convertible Notes | Minimum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 43,900 | $ 43,900 | |
Mann Group Convertible Notes | Maximum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 45,900 | $ 45,900 | |
PPP Loan | |||
Fair Value Of Financial Instruments [Line Items] | |||
Note payable, percentage of hypothetical yield | 12 | 12 | |
Note payable, percentage of interest rate increases (decreases) | 2.00% | ||
PPP Loan | Minimum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 4,700 | $ 4,700 | |
PPP Loan | Maximum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 4,800 | $ 4,800 | |
Senior Convertible Notes | |||
Fair Value Of Financial Instruments [Line Items] | |||
Note payable, percentage of hypothetical yield | 12 | 12 | |
Note payable, percentage of interest rate increases (decreases) | 2.00% | ||
Financial liabilities fair value | $ 257,000 | $ 257,000 | |
Senior Convertible Notes | Carrying Value | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 223,200 | $ 223,200 | |
Senior Convertible Notes | Volatility | |||
Fair Value Of Financial Instruments [Line Items] | |||
Note payable, percentage of volatility | 96 | 96 | |
Senior Convertible Notes | Minimum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 245,400 | $ 245,400 | |
Senior Convertible Notes | Maximum | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | 269,800 | 269,800 | |
Mann Group Convertible Notes | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | 44,900 | 44,900 | 52,200 |
Mann Group Convertible Notes | Carrying Value | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 18,400 | $ 18,400 | 28,000 |
Mann Group Non Convertible Notes | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | 26,700 | ||
Mann Group Non Convertible Notes | Carrying Value | |||
Fair Value Of Financial Instruments [Line Items] | |||
Financial liabilities fair value | $ 35,100 |
Common and Preferred Stock - Ad
Common and Preferred Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Mar. 31, 2021 | Feb. 28, 2021 | Feb. 28, 2018 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Class of Stock [Line Items] | ||||||||
Common stock, shares authorized | 400,000,000 | 400,000,000 | 400,000,000 | |||||
Common stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||
Undesignated preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | |||||
Undesignated preferred stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | |||||
Common stock, shares issued | 249,617,550 | 242,117,089 | 249,617,550 | |||||
Common stock, shares outstanding | 249,617,550 | 242,117,089 | 249,617,550 | |||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||
Debt issuance amount | $ 230,000 | |||||||
Proceeds from market price stock purchase | $ 100 | $ 106 | $ 14 | |||||
Market price stock purchase plan | 25,000 | |||||||
Convertible Promissory Note | Mann Group | ||||||||
Class of Stock [Line Items] | ||||||||
Conversion of notes accrued interest to common shares, value | $ 400 | |||||||
Debt issuance amount | $ 9,600 | $ 7,000 | $ 9,600 | |||||
Conversion of notes to common shares, shares | 4,000,000 | 2,800,000 | 4,000,000 | |||||
2024 Convertible Notes | ||||||||
Class of Stock [Line Items] | ||||||||
Debt issuance amount | $ 5,000 | |||||||
Conversion of notes to common shares, shares | 1,666,667 | |||||||
Controlled Equity Offering Sales Agreement | Cantor Fitzgerald | ||||||||
Class of Stock [Line Items] | ||||||||
Stock sales agreements date | Feb. 28, 2018 | |||||||
Controlled Equity Offering Sales Agreement | Cantor Fitzgerald | Common Stock | Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Amount of net proceeds from issuance of securities | $ 50,000 | |||||||
At Market Issuance Sales Agreement | Cantor Fitzgerald | Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Amount of net proceeds from issuance of securities | $ 1,900 | $ 12,900 | ||||||
Number of shares sold during the period | 578,063 | 7,871,461 | ||||||
At Market Issuance Sales Agreement | Cantor Fitzgerald | Common Stock | Weighted Average | ||||||||
Class of Stock [Line Items] | ||||||||
Exchange price per share | $ 3.26 | $ 3.26 | $ 1.64 |
Earnings Per Common Share ("E_3
Earnings Per Common Share ("EPS") - Components of Basic and Diluted EPS Computations (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
EPS — basic and diluted: | ||||||
Net loss (numerator) | $ (35,523) | $ (12,916) | $ (10,252) | $ (9,322) | $ (48,439) | $ (19,574) |
Weighted average common shares (denominator) | 249,295 | 213,880 | 247,970 | 212,943 | ||
Net loss per share | $ (0.14) | $ (0.05) | $ (0.20) | $ (0.09) |
Earnings Per Common Share ("E_4
Earnings Per Common Share ("EPS") - Potential Dilutive Securities Outstanding that are Considered Antidilutive (Detail) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 72,102,908,000 | 32,845,926,000 |
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 | 11,092,080,000 | 13,197,927,000 |
RSUs and Market RSUs | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 7,986,898,000 | 2,501,713,000 |
Employee Stock Purchase Plan | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 250,000,000 | 276,154,000 |
Senior Convertible Notes | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 44,120,463,000 | |
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 | 7,370,000,000 | 14,000,000,000 |
Convertible Note | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 1,666,667,000 | |
Warrants Associated with MidCap Credit Facility | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 1,283,467,000 | 1,171,614,000 |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 31,851,000 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Employee Awards and Non-employee Director Award Plan Activity (Detail) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 2,711,066 | 370,137 | 3,081,203 |
Employees Awards | RSUs | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 1,476,059 | 370,137 | 1,846,196 |
Employees Awards | Market RSU's | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 918,775 | 918,775 | |
Non-employee Directors Awards | RSUs | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted awards | 316,232 | 316,232 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Employee Awards and Non-employee Director Award Plan Activity (Parenthetical) (Detail) - $ / shares shares in Thousands | 3 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2021 | |
RSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units weighted average grant date fair value | $ 5.53 | |
Employees Awards | RSUs | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units weighted average grant date fair value | $ 4.26 | |
Vesting period | 4 years | |
Employees Awards | RSUs | Share-based Payment Arrangement, Tranche One | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Vesting period | 1 year | |
Restricted stock units grant date fair value | 202,237 | |
Employees Awards | RSUs | Share-based Payment Arrangement, Tranche Two | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Vesting period | 4 years | |
Restricted stock units grant date fair value | 167,900 | |
Employees Awards | Market RSU's | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock units weighted average grant date fair value | $ 9.30 | |
Vesting date | May 17, 2024 | |
Employees Awards | Market RSU's | 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 | 0.00% | |
Employees Awards | Market RSU's | 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 | 50.00% | |
Employees Awards | Market RSU's | Index Target 50th Percentile | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 100.00% | |
Employees Awards | Market RSU's | Index Target 75th Percentile | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 200.00% | |
Employees Awards | Market RSU's | 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 | 300.00% | |
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 | $ 4.31 |
Stock-Based Compensation Expe_3
Stock-Based Compensation Expense - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Issuance of common stock under Employee Stock Purchase Plan | $ 390,000 | $ 318,000 | ||
Common Stock | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Issuance of common stock under Employee Stock Purchase Plan | $ 3,000 | $ 3,000 | ||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 293,000 | 334,000 | 292,981 | 333,727 |
ESPP | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock available for issuance | 1,300,000 | |||
Employees Awards | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Issuance of common stock under Employee Stock Purchase Plan | $ 25,000 | |||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 5,000 | |||
Employees Awards | ESPP | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Discount on purchase price percentage of fair market value | 85.00% | |||
Options and PNQs | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized compensation expense related to options | $ 3,400,000 | |||
Unrecognized compensation expense, weighted average period for recognition | 1 year 7 months 6 days | |||
RSUs | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized compensation expense, weighted average period for recognition | 3 years 4 months 24 days | |||
Unrecognized compensation expense related to non-option | $ 12,600,000 | |||
Market RSU's | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Unrecognized compensation expense, weighted average period for recognition | 2 years 7 months 6 days | |||
Unrecognized compensation expense related to non-option | $ 12,500,000 |
Stock-Based Compensation Expe_4
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, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock compensation expense | $ 3,926 | $ 2,185 | $ 5,861 | $ 3,313 |
RSUs and Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock compensation expense | 3,819 | 2,122 | 5,625 | 3,188 |
Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock compensation expense | $ 107 | $ 63 | $ 236 | $ 125 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Nov. 30, 2017USD ($) | May 31, 2017USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2021USD ($)Vehicle | Nov. 30, 2020$ / sharesshares | Aug. 31, 2019$ / sharesshares | Jul. 01, 2013USD ($) | |
Commitments And Contingencies [Line Items] | |||||||
Supply Agreement expiration period | Dec. 31, 2027 | ||||||
Supply Agreement renewal period | 2 years | ||||||
Lease Agreement with Enterprise | Vehicle Leases | |||||||
Commitments And Contingencies [Line Items] | |||||||
Number of vehicle leases remove | Vehicle | 10 | ||||||
Number of vehicle leases | Vehicle | 78 | ||||||
Operating lease rent expenses | $ 69,000 | ||||||
Gain or loss recorded for leases removed | 0 | ||||||
Cost of Goods Sold | |||||||
Commitments And Contingencies [Line Items] | |||||||
Payment of long term purchase commitment, amendment fees | $ 2,000,000 | 2,000,000 | |||||
MidCap Credit Facility | |||||||
Commitments And Contingencies [Line Items] | |||||||
Warrants to purchase common stock | shares | 111,853 | 1,171,614 | |||||
Exercise price of warrants | $ / shares | $ 2.91 | $ 1.11 | |||||
Deerfield | Milestone Rights Liability | |||||||
Commitments And Contingencies [Line Items] | |||||||
Contingent liability remain payable | 65,000,000 | 65,000,000 | |||||
Accrued expenses and other current liabilities | 1,100,000 | 1,100,000 | |||||
Milestone rights liability | $ 4,800,000 | $ 4,800,000 | |||||
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 | $ 35,969 | $ 40,951 | |||||
Percentage of annual increase in lease payment | 3.00% | 3.00% | |||||
Lease expiration | 2023-01 | 2023-01 | |||||
Lease renewal option | 5 years | 5 years | |||||
Reimbursement amount received for tenant improvements | $ 56,325 |
Commitments and Contingencies_2
Commitments and Contingencies - Remaining Purchase Requirements (Detail) - EUR (€) € in Millions | Jun. 30, 2021 | Mar. 31, 2021 |
Purchase Obligation Fiscal Year Maturity [Abstract] | ||
2021 | € 2 | € 7 |
2022 | 5.4 | 8.5 |
2023 | 8.7 | 10.9 |
2024 | 14.6 | 14.6 |
2025 | 15.5 | 15.5 |
2026 | 19.4 | € 19.4 |
2027 | € 9.2 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Lease Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | ||||
Operating lease costs | $ 340 | $ 352 | $ 685 | $ 703 |
Variable lease costs | 114 | 79 | 231 | 180 |
Cash paid | $ 454 | $ 431 | $ 916 | $ 883 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Lease Term and Discount Rate (Detail) | Jun. 30, 2021 | Dec. 31, 2020 |
Commitments And Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term (in years) | 1 year 6 months | 1 year 10 months 24 days |
Weighted average discount rate | 7.30% | 7.50% |
Commitments and Contingencies_5
Commitments and Contingencies - Schedule of Future Minimum Office And Vehicle Lease Payments (Detail) - office and vehicle - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Commitments And Contingencies [Line Items] | ||
Remainder of fiscal year | $ 722 | |
Year 1 | 1,213 | $ 1,494 |
Year 2 | 88 | 1,239 |
Year 3 | 88 | |
Total | $ 2,023 | $ 2,821 |