MANNKIND CORP 10-Q

ITEM 1. FINANCIAL STATEMENTS MANNKIND CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In thousands, except share and per share data) September 30, 2022 December 31, 2021 ASSETS Current assets: Cash and cash equivalents $ 54,308 $ 124,184 Short-term investments 110,738 79,932 Accounts receivable, net 23,493 4,739 Inventory 18,273 7,152 Prepaid expenses and other current assets 11,569 3,482 Total current assets 218,381 219,489 Property and equipment, net 41,182 36,612 Goodwill 3,067 — Other intangible asset 1,169 — Long-term investments 12,728 56,619 Other assets 17,310 8,441 Total assets $ 293,837 $ 321,161 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 9,871 $ 6,956 Accrued expenses and other current liabilities 30,350 27,419 Financing liability — current 9,525 6,977 Deferred revenue — current 1,786 827 Recognized loss on purchase commitments — current 8,065 6,170 Total current liabilities 59,597 48,349 Senior convertible notes 225,034 223,944 Midcap credit facility 39,155 38,833 Mann Group convertible note 8,829 18,425 Accrued interest — promissory note 56 404 Financing liability — long term 94,484 93,525 Recognized loss on purchase commitments — long term 62,173 76,659 Operating lease liability 5,666 1,040 Deferred revenue — long term 31,996 19,543 Milestone liabilities 4,524 4,838 Deposits from customer — 4,950 Total liabilities 531,514 530,510 Commitments and contingencies (Note 15) Stockholders' deficit: Undesignated preferred stock, $ 0.01 par value — 10,000,000 shares authorized; no shares issued or outstanding as of September 30, 2022 and December 31, 2021 — — Common stock, $ 0.01 par value - 400,000,000 shares authorized, 263,156,165 and 251,477,562 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively 2,632 2,515 Additional paid-in capital 2,960,419 2,918,205 Accumulated other comprehensive loss ( 1,206 ) — Accumulated deficit ( 3,199,522 ) ( 3,130,069 ) Total stockholders' deficit ( 237,677 ) ( 209,349 ) Total liabilities and stockholders' deficit $ 293,837 $ 321,161 See notes to condensed consolidated financial statements. 2 MANNKIND CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Revenues: Net revenue — commercial product sales $ 16,259 $ 9,753 $ 38,807 $ 27,828 Revenue — collaborations and services 10,346 12,458 18,380 35,099 Royalties — collaborations 6,220 — 6,524 — Total revenues 32,825 22,211 63,711 62,927 Expenses: Cost of goods sold 5,021 3,812 11,922 12,538 Cost of revenue — collaborations and services 12,439 6,075 29,451 14,885 Research and development 4,136 3,655 12,565 8,426 Selling, general and administrative 22,638 17,221 69,378 54,690 Asset impairment — 106 — 106 Gain on foreign currency translation ( 1,799 ) ( 2,068 ) ( 8,285 ) ( 5,003 ) Loss on purchase commitments — — — 339 Total expenses 42,435 28,801 115,031 85,981 Loss from operations ( 9,610 ) ( 6,590 ) ( 51,320 ) ( 23,054 ) Other (expense) income: Interest income, net 663 36 1,556 64 Interest expense on financing liability ( 2,466 ) — ( 7,280 ) — Interest expense on notes ( 2,812 ) ( 2,803 ) ( 12,202 ) ( 12,435 ) Gain (loss) on extinguishment of debt, net — 4,930 — ( 17,200 ) Other (expense) income ( 207 ) 1 ( 207 ) ( 240 ) Total other expense ( 4,822 ) 2,164 ( 18,133 ) ( 29,811 ) Loss before provision for income taxes ( 14,432 ) ( 4,426 ) ( 69,453 ) ( 52,865 ) Provision for income taxes — — — — Net loss $ ( 14,432 ) $ ( 4,426 ) $ ( 69,453 ) $ ( 52,865 ) Net loss per share - basic and diluted $ ( 0.06 ) $ ( 0.02 ) $ ( 0.27 ) $ ( 0.21 ) Shares used to compute net loss per share - basic and diluted 259,300 249,910 254,974 248,624 See notes to condensed consolidated financial statements. 3 MANNKIND CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) (In thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net loss $ ( 14,432 ) $ ( 4,426 ) $ ( 69,453 ) $ ( 52,865 ) Other comprehensive loss: Unrealized loss on available-for-sale securities — — ( 1,206 ) — Comprehensive loss $ ( 14,432 ) $ ( 4,426 ) $ ( 70,659 ) $ ( 52,865 ) See notes to condensed consolidated financial statements. 4 MANNKIND CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT (Unaudited) (In thousands) Common Stock Additional Accumulated Other Accumulated Shares Amount Paid-in Capital Comprehensive Loss Deficit Total BALANCE, JANUARY 1, 2021 242,118 $ 2,421 $ 2,866,303 $ — $ ( 3,049,143 ) $ ( 180,419 ) Net issuance of common stock associated with stock options and restricted stock units 390 4 393 — — 397 Issuance of common stock under Employee Stock Purchase Plan 293 3 387 — — 390 Stock-based compensation expense — — 1,935 — — 1,935 Issuance of common stock pursuant to conversion of the Mann Group convertible note 3,830 38 9,535 — — 9,573 Issuance of common stock pursuant to conversion of the Mann Group convertible note interest 170 2 425 — — 427 Issuance of common stock pursuant to conversion of the 2024 convertible notes 1,667 17 4,983 — — 5,000 Issuance of common stock pursuant to payoff of the 2024 convertible note interest 27 — 143 — — 143 Issuance of at-the-market placement 578 6 1,880 — — 1,886 Issuance costs associated with at-the- market placement — — ( 38 ) — — ( 38 ) Net loss — — — — ( 12,916 ) ( 12,916 ) BALANCE, MARCH 31, 2021 249,073 $ 2,491 $ 2,885,946 $ — $ ( 3,062,059 ) $ ( 173,622 ) Net issuance of common stock associated with stock options and restricted stock units 520 5 ( 550 ) — — ( 545 ) 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 25 — 106 — — 106 Net loss — — — — ( 35,523 ) ( 35,523 ) BALANCE, JUNE 30, 2021 249,618 $ 2,496 $ 2,911,535 $ — $ ( 3,097,582 ) $ ( 183,551 ) Issuance of common stock associated with debt interest payment 394 4 ( 594 ) — — ( 590 ) Net issuance of common stock associated with stock options and restricted stock units 234 2 698 — — 700 Stock-based compensation expense — — 3,179 — — 3,179 Net loss — — — — ( 4,426 ) ( 4,426 ) BALANCE, SEPTEMBER 30, 2021 250,246 $ 2,502 $ 2,914,818 $ — $ ( 3,102,008 ) $ ( 184,688 ) 5 Common Stock Additional Accumulated Other Accumulated Shares Amount Paid-in Capital Comprehensive Loss Deficit Total BALANCE, JANUARY 1, 2022 251,478 $ 2,515 $ 2,918,205 $ — $ ( 3,130,069 ) $ ( 209,349 ) Net issuance of common stock associated with stock options and restricted stock units 450 4 125 — — 129 Issuance of common stock under Employee Stock Purchase Plan 233 2 738 — — 740 Stock-based compensation expense — — 2,806 — — 2,806 Issuance of common stock from market price stock purchase plan 252 3 681 — — 684 Cumulative loss on available-for-sale securities — — — ( 1,076 ) — ( 1,076 ) Net loss — — — — ( 25,998 ) ( 25,998 ) BALANCE, MARCH 31, 2022 252,413 $ 2,524 $ 2,922,555 $ ( 1,076 ) $ ( 3,156,067 ) $ ( 232,064 ) Issuance of common stock pursuant to conversion of Mann Group convertible note 3,838 39 9,557 — — 9,596 Issuance of common stock pursuant to conversion of the Mann Group convertible note interest 193 2 518 — — 520 Net issuance of common stock associated with stock options and restricted stock units 833 8 ( 385 ) — — ( 377 ) Stock-based compensation expense — — 4,422 — — 4,422 Cumulative loss on available-for-sale securities — — — ( 130 ) — ( 130 ) Net loss — — — — ( 29,023 ) ( 29,023 ) BALANCE, JUNE 30, 2022 257,277 $ 2,573 $ 2,936,667 $ ( 1,206 ) $ ( 3,185,090 ) $ ( 247,056 ) Issuance of at-the-market placement 5,060 51 19,739 — — 19,790 Issuance costs associated with at-the- market placement — — ( 381 ) — — ( 381 ) Issuance of common stock pursuant to conversion of the Mann Group convertible note interest 26 — 99 — — 99 Issuance of common stock under Employee Stock Purchase Plan 298 3 870 — — 873 Net issuance of common stock associated with stock options and restricted stock units 495 5 ( 197 ) — — ( 192 ) Stock-based compensation expense — — 3,622 — — 3,622 Net loss — — — — ( 14,432 ) ( 14,432 ) BALANCE, SEPTEMBER 30, 2022 263,156 $ 2,632 $ 2,960,419 $ ( 1,206 ) $ ( 3,199,522 ) $ ( 237,677 ) See notes to condensed consolidated financial statements. 6 MANNKIND CORPORATION AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (In thousands) Nine Months Ended September 30, 2022 2021 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 69,453 ) $ ( 52,865 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 10,850 9,040 Interest expense on financing liability 7,127 — Interest on milestone payment — 3,663 Depreciation and amortization 4,504 2,995 Amortization of right-of-use assets 2,655 505 Interest expense on Mann Group promissory note 270 — Gain on foreign currency translation ( 8,285 ) ( 5,003 ) Write-off of inventory 1,368 — Payment-in-kind interest on Mann Group promissory note — 1,480 Loss on extinguishment of debt — 17,200 Asset impairment — 106 Changes in operating assets and liabilities: Accounts receivable, net ( 18,499 ) ( 5,227 ) Inventory ( 1,337 ) ( 2,509 ) Prepaid expenses and other current assets ( 8,087 ) ( 105 ) Other assets ( 568 ) ( 439 ) Accounts payable 2,916 3,946 Accrued expenses and other current liabilities ( 2,935 ) 3,471 Deferred revenue 13,412 ( 19,369 ) Operating lease liabilities ( 2,985 ) ( 1,367 ) Recognized loss on purchase commitments ( 4,306 ) ( 4,972 ) Accrued interest on Mann Group Mann Group promissory note — ( 4,919 ) Customer deposits ( 4,950 ) 5,007 Net cash used in operating activities ( 78,303 ) ( 49,362 ) CASH FLOWS FROM INVESTING ACTIVITIES: Proceeds from maturity of debt securities 82,584 105,724 Purchase of debt securities ( 70,128 ) ( 235,406 ) Acquisition of V-Go ( 15,099 ) — Purchase of available-for-sale securities ( 5,000 ) ( 3,000 ) Purchase of property and equipment ( 2,493 ) ( 6,276 ) Net cash used in investing activities ( 10,136 ) ( 138,958 ) CASH FLOWS FROM FINANCING ACTIVITIES: Payment on financing liability ( 2 ) — Proceeds from market price stock purchase plan 684 106 Payment of employment taxes related to vested restricted stock units and exercise of stock options ( 440 ) ( 738 ) Proceeds from the Senior convertible notes — 230,000 Issuance costs associated with Senior convertible notes — ( 7,268 ) Principal payments on Mann Group Mann Group promissory note — ( 35,051 ) Payment of MidCap credit facility — ( 10,000 ) Payment of MidCap credit facility prepayment penalty — ( 1,000 ) Milestone payment ( 1,088 ) ( 5,000 ) Proceeds from at-the-market offering 19,790 1,886 Issuance costs associated with at-the-market offering ( 381 ) ( 38 ) Net cash provided by financing activities 18,563 172,897 NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS ( 69,876 ) ( 15,423 ) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 124,184 67,163 CASH AND CASH EQUIVALENTS, END OF PERIOD $ 54,308 $ 51,740 SUPPLEMENTAL CASH FLOWS DISCLOSURES: Interest paid in cash $ 5,143 $ 10,535 NON-CASH INVESTING AND FINANCING ACTIVITIES: Reclassification of investments from long-term to current 72,090 20,747 Payments on debt and interest through common stock issuance 10,215 15,145 Modification of operating leases 3,794 ( 744 ) Addition of right-of-use asset 1,812 744 Non-cash construction in progress and property and equipment 1,433 154 Common stock issuance to settle employee stock purchase plan liability 1,613 1,090 Contingent milestone liability 610 — Premium on Mann Group convertible note — 22,107 Forgiveness of PPP loan — ( 4,873 ) See notes to condensed consolidated financial statements. 7 MANNKIND CORPORATION AND SUBSIDIARIES NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 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, 2021, filed with the SEC on February 24, 2022 (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 nine months ended September 30, 2022 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. In addition, the ongoing COVID-19 pandemic has increased the level of judgment used by management in developing these estimates and assumptions, particularly given that the ultimate impact of the COVID-19 pandemic is 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, including gross-to-net adjustments, stand-alone selling price considerations for recognition of collaboration revenue, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitment, 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 focuses on the development and commercialization of therapeutic products for patients with endocrine and orphan lung diseases. The Company is currently commercializing Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. The Company also collaborates with third parties to formulate their drugs on the Company’s Technosphere drug delivery platform. In May 2022, the Company’s partner, United Therapeutics Corporation (“United Therapeutics” or “UT”), received approval from the U.S. Food and Drug Administration (“FDA”) for Tyvaso DPI (treprostinil) inhalation powder, which is indicated for the treatment of pulmonary arterial hypertension and for the treatment of pulmonary hypertension associated with interstitial lung disease. UT began commercializing Tyvaso DPI in June 2022 and is obligated to pay the Company a royalty on net sales of the product. The Company also receives a margin on supplies of Tyvaso DPI that it manufactures for UT. Basis of Presentation — The 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 its diabetes products, and development of other product candidates in the Company’s pipeline. As of September 30, 2022, the Company had capital resources of $ 54.3 million in cash and cash equivalents, $ 110.7 million in short-term investments, $ 12.7 million in long-term investments, $ 278.8 million of total principal amount of outstanding borrowings, $ 104.0 million of total amount of financial liability related to a sale-leaseback transaction, and an accumulated deficit of $ 3.2 billion. In August 2019, MannKind 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 $ 100.0 million, with a balance of $ 40.0 million borrowed as of September 30, 2022. The final $ 60.0 million tranche became available through June 30, 2022 after the Tyvaso DPI approval by the FDA. The Company did not exercise its right to borrow the final tranche. See Note 9 – Borrowings . In March 2021, the Company issued $ 230.0 million of 2.50 % convertible senior notes due 2026 (the “Senior convertible notes”) to provide additional operating capital and pay down higher cost debt. 8 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. 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. Certain prior year amounts have been reclassified for consistency with the current year presentation. Changes were made to the condensed consolidated statement of operations to disclose a single caption for interest expense on all outstanding notes. Changes were made to the condensed consolidated balance sheets to reclassify interest receivable from investments from accounts receivable, net to other assets. 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”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company has two types of contracts with customers: (i) contracts for commercial product sales with wholesale distributors, specialty and retail pharmacies and (ii) collaboration arrangements. Revenue Recognition – Net Revenue – Commercial Product Sales – The Company sells its products to a limited number of wholesale distributors, specialty and retail pharmacies, and durable medical equipment suppliers (“DME”) in the U.S. (collectively, its “Customers”). Wholesale distributors subsequently resell the Company’s products to retail pharmacies and certain medical centers or hospitals. Specialty and retail pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at delivery for wholesale distributors and generally at delivery for specialty pharmacies. The Company recognizes revenue on product sales to a retail pharmacy as the product is dispensed to patients. Product revenues are recorded net of applicable reserves, including discounts, allowances, rebates, returns and other incentives. See Reserves for Variable Consideration below. Free Goods Program – From time to time, the Company offers programs to potential new patients that allow them to obtain free goods (prescription fills) from a pharmacy. 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 ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reduce recognized revenue to the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. 9 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 September 30 , 202 2 and, therefore, the transaction price was not reduced further during the nine months ended September 30 , 2022 . 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 the Company’s assumptions. Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase products from the Company. Customers charge the Company for the difference between what they pay for products and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is recorded in accrued expenses and other current liabilities. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit. Government Rebates — The Company is subject to discount obligations under Medicare and state Medicaid programs. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities. Estimates around Medicaid have historically required significant judgment due to timing lags in receiving invoices for claims from states. For Afrezza, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for products that have been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel. Payer Rebates — The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates, including estimates for product that has been recognized as revenue, but which remains in the distribution channel, and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel. 10 Other Incentives — Other incentives which the Company offers include voluntary patient support programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with co-payments required by pay e rs. 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 product s 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. With respect to our significant collaboration and service agreement with UT that includes a long-term commercial supply agreement (as amended, the “CSA”), we have identified three distinct performance obligations: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI (“R&D Services and License”); (2) development activities for the next generation of the product (“Next-Gen R&D Services”); and (3) a material right associated with future commercial manufacturing and supply of product (“Manufacturing Services”). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were considered bundled services under the Manufacturing Services performance obligation as required by ASC 606. Following the FDA’s approval of Tyvaso DPI, UT began issuing purchase orders for the supply of product, which represent distinct contracts and performance obligations under ASC 606. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT. See Note 10 – Collaboration, Licensing and Other Arrangements. If an arrangement has multiple performance obligations, the allocation of the transaction price is determined from observable market inputs, and the Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue. Current deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. For further information, see Note 10 – Collaboration, Licensing and Other Arrangements. The Company recognizes upfront license payments as revenue upon delivery of the license only if the license is determined to be a separate unit of accounting from the other undelivered performance obligations. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the license is not considered as a distinct performance obligation, then the license and other undelivered performance obligations would be evaluated to determine if such should be accounted for as a single unit of accounting. If concluded to be a single performance obligation, the transaction price for the single performance obligation is recognized as revenue over the estimated period of when the performance obligation is satisfied. If the license is considered to be a distinct performance obligation, then the estimated revenue is included in the transaction price for the contract, which is then allocated to each performance obligation based on the respective standalone selling prices. If the revenue for a sales-based or usage-based royalty is promised in exchange for an intellectual property license, the Company recognizes revenue as the latter of the subsequent sale or usage occurs or the performance obligation to which the royalty has been allocated has been satisfied or partially 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 11 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, semi-finished goods or finished goods, provides research and development services and offers sales support for the co-promotion of products, all of which are outputs of the Company’s ongoing activities, in exchange for consideration. Accordingly, the Company concluded that its collaborative agreements must generally be accounted for pursuant to ASC 606. For collaboration agreements that allow collaboration partners to select additional optioned products or services, the Company evaluates whether such options contain material rights (i.e., have exercise prices that are discounted compared to what the Company would charge for a similar product or service to a new collaboration partner). The exercise price of these options includes a combination of licensing fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, the Company concludes the option does not contain a material right, and therefore is not included in the transaction price at contract inception. The Company assessed the CSA agreement with UT and determined that a material right existed for the manufacturing services performance obligation. The transaction price is allocated to the material right as well as the remaining performance obligations in accordance with ASC 606. The Company also evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts. The Company’s net revenue and cost of revenue and goods sold as shown on the condensed consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net revenue (in thousands) Product sales (1) $ 26,175 $ 9,753 $ 54,602 $ 27,828 Services (2) 430 12,458 2,585 35,099 Royalties (3) 6,220 — 6,524 — Total net revenue $ 32,825 $ 22,211 $ 63,711 $ 62,927 _________________________ (1) Amounts represent the sales of Afrezza and V-Go to wholesalers and specialty pharmacies and Tyvaso DPI to UT. (2) Amounts represent revenue generated from our collaboration arrangements, including Next-Gen R&D Services (as defined in Note 10) for UT as well as arrangements with other collaboration partners. See Note 10 – Collaboration, Licensing and Other Arrangements . (3) Amounts represent royalties on UT’s net sales of Tyvaso DPI. Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Cost of goods sold and cost of revenue (in thousands) Product sales $ 17,067 $ 3,812 $ 39,424 $ 12,538 Services 393 6,075 1,949 14,885 Total cost of goods sold and cost of revenue $ 17,460 $ 9,887 $ 41,373 $ 27,423 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. 12 Cost of Goods Sold — Cost of goods sold includes material, labor costs and manufacturing overhead. Cost of goods sold also includes a component of current period manufacturing costs in excess of costs capitalized into inventory (“excess capacity costs”). These costs, in addition to the impact of the revaluation of inventory for standard costing, and write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of goods sold excludes the cost of insulin purchased under the Company’s Insulin Supply Agreement (the “Insulin Supply Agreement”) with Amphastar Pharmaceuticals, Inc. (“Amphastar”) . All insulin inventory on hand was written off and the full purchase commitment contract to purchase future insulin was accrued as a recognized loss on purchase commitments as of the end of 2015. Cost of Revenues – Collaborations and Services — Cost of revenues – collaborations and services includes material, labor costs, manufacturing overhead, and excess capacity costs. These costs, in addition to the write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of revenues – collaborations and services also includes the cost of product development. Cash and Cash Equivalents — The Company considers all highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase, that are readily convertible into cash to be cash equivalents. As of September 30, 2022 and December 31, 2021, cash equivalents were comprised of money market funds, corporate bonds and commercial paper accounts with original maturities less than 90 days from the date of purchase. Held-to-Maturity Investments — The Company’s investments generally consist of commercial paper, corporate notes or bonds and U.S. Treasury securities. As of September 30, 2022, the Company held short-term and long-term investments of debt securities, including commercial paper and bonds. The Company assesses whether it has any intention to sell the investment before maturity, whether any declines in fair value are the result of credit losses, as well as whether there were other-than-temporary impairments associated with the available for sale investment. The Company intends to hold its investments until maturity; therefore, these investments are stated at amortized cost. The investments with maturities less than 12 months are included in short-term investments and investments with maturities in excess of twelve months are included in long-term investments in the condensed consolidated balance sheets. The amortization or accretion of the Company’s investments is recognized as interest income in the condensed consolidated statements of operations. Available-for-Sale Investment — In June 2021, the Company purchased a $ 3.0 million convertible promissory note (the “Thirona convertible note”) issued by Thirona Bio, Inc. (“Thirona”). In January 2022, the Company purchased an additional $ 5.0 million convertible promissory note issued by Thirona. Unless earlier converted into conversion shares pursuant to the note purchase agreement, the 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 31, 2023 . Interest accrues at a rate of 6 % per annum. The Thirona convertible notes are general unsecured obligations of Thirona. The Thirona convertible notes are classified as available-for-sale securities and are 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 assesses whether it has any intention to sell the investment, determines fair value of its available-for-sale investments using level 3 inputs as well as assesses whether there were other-than-temporary impairments associated with the available-for-sale investment. 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 10– Collaboration, Licensing and Other Arrangements 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 funds and U.S. Treasury securities with original or remaining maturities of 90 days or less at the time of purchase. 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 Credit Losses — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for credit losses if there are estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for credit losses. The allowance for expected credit losses is based primarily on past collections experience relative to the length of time receivables are past due. However, when available evidence reasonably supports an assumption that future economic conditions will differ from current and historical payment collections, an adjustment is reflected in the allowance for expected credit losses. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company’s customers have the right of setoff for these amounts against the related accounts receivable. 13 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 are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company’s products based on management’s judgment that future economic benefits are expected to be realized; otherwise, such costs are expensed as incurred as cost of goods sold. The Company uses a contract manufacturing organization outside of the U.S. for certain stages of V-Go inventory. The Company periodically analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value and writes down such inventories, as appropriate. In addition, the Company’s products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or may become obsolete or are forecasted to become obsolete due to expiration, the Company will record a charge to write down such unmarketable inventory to its estimated net realizable value. The Company analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. The Company performs an assessment of projected sales and evaluates the lower of cost or net realizable value and the potential excess inventory on hand at the end of each reporting period. 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. Acquisitions — The Company first determines whether a set of assets acquired constitute a business and should be accounted for as a business combination. If the assets acquired do not constitute a business, the Company accounts for the transaction as an asset acquisition. Business combinations are accounted for by means of the acquisition method of accounting. Under the acquisition method, assets acquired, including in-process research and development (“IPR&D”) projects, and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company’s consolidated financial statements. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with a business combination (including the assumption of an acquiree’s liability arising from an acquisition it consummated prior to the Company’s acquisition) are recorded at their fair values on the acquisition date and remeasured at their fair values each subsequent reporting period until the related contingencies have been resolved. The resulting changes in fair values are recorded in earnings. In contrast, asset acquisitions are accounted for by using a cost accumulation and allocation model. Under this model, the cost of the acquisition is allocated to the assets acquired and liabilities assumed. IPR&D projects with no alternative future use are recorded in R&D expense upon acquisition, and contingent consideration obligations incurred in connection with an asset acquisition are recorded when it is probable that they will occur and they can be reasonably estimated. See Note 2 – Acquisition. Goodwill and Other Intangible Assets – The fair value of acquired intangible assets is determined using an income-based approach referred to as the excess earnings method utilizing Level 3 fair value inputs. Market participant valuations assume a global view considering all potential jurisdictions and indications based on discounted after-tax cash flow projections, risk adjusted for estimated probability of technical and regulatory success. The Company tests for impairment annually on a reporting unit basis, at the beginning of the Company’s fourth fiscal quarter and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying amount. To the extent the carrying amount of a reporting unit is less than its estimated fair value, an impairment charge will be recorded. 14 Finite-lived intangible assets are amortized on a straight-line basis over the estimated useful life. Estimated useful lives are determined considering the period assets are expected to contribute to future cash flows. Finite-lived intangible assets are tested for impairment when facts or circumstances suggest that the carrying value of the asset may not be recoverable. If the carrying value exceeds the projected undiscounted pretax cash flows of the intangible asset, an impairment loss equal to the excess of the carrying value over the estimated fair value (discounted after-tax cash flows) is recognized. Recognized Loss on Purchase Commitments — 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 as of September 30, 2022 and December 31, 2021 was $ 70.2 million and $ 82.8 million, respectively. No new contracts were identified in 2021 or in the first nine months of 2022 that required a new loss on purchase commitment accrual. Milestone Rights Liability — In July 2013, in conjunction with the execution of a (now repaid) loan agreement with Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) , the Company entered into a Milestone Rights Purchase Agreement (the “Milestone Rights Agreement”) pursuant to which the Company issued certain milestone rights to Deerfield Private Design Fund II, L.P. and Horizon Santé FLML SÁRL (the “Original Milestone Purchasers”). The foregoing milestone rights provided the Original Milestone Purchasers certain rights to receive payments of up to $ 90.0 million upon the occurrence of specified strategic and sales milestones, $ 60.0 million of which remains payable upon achievement of such milestones (collectively, the “Milestone Rights”). In December 2021, the Milestone Rights were purchased by Barings Global Special Situations Credit Fund 4 (Delaware), L.P. and Barings Global Special Situations Credit 4 (LUX) S.ar.l. (together the “Milestone Purchasers”). As a result, the Milestone Purchasers have assumed the obligations of the Original Milestone Purchasers and is now entitled to all rights under the Milestone Rights Agreement. As of September 30, 2022, $ 60.0 million remained payable pursuant to the Milestone Rights Agreement upon achievement of Afrezza net sales milestones. The Milestone Rights liability is reported at fair value at the date of the agreement which is periodically offset against payments. (See Note 11 – Fair Value of Financial Instruments ) . The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones and discounted to present value using a selected market discount rate. The expected timing and probability of achieving the milestones was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The Milestone Rights liability will be remeasured as the specified milestone events are achieved. Specifically, as each milestone event is achieved, the portion of the initially recorded Milestone Rights liability that pertains to the milestone event being achieved, will be remeasured to the amount of the specified related milestone payment. The resulting change in the balance of the Milestone Rights liability due to remeasurement will be recorded in the Company’s condensed consolidated statements of operations as interest expense. Furthermore, the Milestone Rights liability will be reduced upon the settlement of each milestone payment. As a result, each milestone payment would be effectively allocated between a reduction of the recorded Milestone Rights liability and an expense representing a return on a portion of the Milestone Rights liability paid to the investor for the achievement of the related milestone event (see Note 9 – Borrowings ). 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 — 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. 15 For uncertain tax positions, the Company determines whether it is “more likely than not” that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit can be recorded in the financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Penalties, if probable and reasonably estimable, are recognized as a component of income tax expense. The Company has reduced its deferred tax assets for uncertain tax positions but has not recorded liabilities for income tax expense, penalties, or interest. Contingencies — 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 — 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, 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. Net Income (Loss) Per Share of Common Stock — Basic net income or loss per share excludes dilution for potentially dilutive securities and is computed by dividing net income or loss by the weighted average number of common shares outstanding during the period. Diluted net income or loss per share reflects the potential dilution under the treasury method that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. For periods where the Company has presented a net loss, potentially dilutive securities are excluded from the computation of diluted net loss per share as they would be anti-dilutive . Recently Issued Accounting Standards — In March 2020, the Financial Accounting Standards Board (“FASB”) issued a new accounting standard to ease the financial reporting burdens caused by the expected market transition from LIBOR and other interbank offered rates to alternative reference rates, commonly referred to as reference rate reform. The new standard provides temporary optional expedients and exceptions to current GAAP guidance on contract modifications and hedge accounting. Specifically, a modification to transition to an alternative reference rate is treated as an event that does not require contract remeasurement or reassessment of a previous accounting treatment. Moreover, for all types of hedging relationships, an entity is permitted to change the reference rate without having to redesignate the hedging relationship. The standard is generally effective for all contract modifications made and hedging relationships evaluated through December 31, 2022. In January 2021, the FASB issued a new accounting standard that expanded the scope of the original March 2020 standard to include derivative instruments on discounting transactions. The Company has adopted these standards in the third quarter of 2022 using the prospective method and has determined there is no impact on our condensed consolidated financial statements. In November 2021, the FASB issued a new accounting standard around the recognition and measurement of contract assets and contract liabilities from revenue contracts with customers acquired in a business combination. The new standard clarifies that contract assets and contract liabilities acquired in a business combination from an acquiree should initially be recognized by applying revenue recognition principles and not at fair value. The standard is effective for interim and annual periods beginning on January 1, 2023, and early adoption is permitted. The impact of this standard will depend on the facts and circumstances of future transactions. Fr om time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s condensed consolidated financial position or results of operations upon adoption. 16 2. Acquisition On May 17, 2022 , the Company entered into an Asset Purchase Agreement (the “APA”) to purchase from Zealand Pharma A/S and Zealand Pharma US, Inc. (together “Zealand”) certain assets and assume certain liabilities associated with the V-Go wearable insulin delivery device. The transaction closed on May 31, 2022 (the “Acquisition Date”). Under the terms of the APA, the Company paid up-front consideration of $ 15.1 million for certain assets and assumed liabilities related to V-Go. In addition, the Company will be obligated to make one-time, sales-based milestone payments to Zealand totaling up to a maximum of $ 10.0 million upon the achievement of specified annual revenue milestones between $ 40 million and $ 100 million. The total preliminary purchase consideration for V-Go was as follows (in thousands): Fair value of consideration: Amount Cash consideration $ 15,099 Fair value of contingent consideration 610 Total $ 15,709 The transaction was accounted for using the acquisition method of accounting, which requires, among other things, the assets acquired and liabilities assumed to be recognized at their respective fair values as of the acquisition date. The excess of the purchase price over those fair values was recorded as goodwill, which will be amortized over a period of 15 years for tax purposes. The estimates and assumptions used include the projected timing and amount of future cash flows and discount rates to reflect the risk inherent in the future cash flows. The estimated fair values of assets acquired and liabilities assumed and resulting goodwill are subject to adjustment as the Company finalizes its purchase price accounting. The significant items for which a final fair value has not been determined include, but are not limited to the valuation of the intangible asset and assumed liabilities for rebates and return reserves. The Company does not expect its fair value determinations to materially change; however, there may be differences between the amounts recorded at the Acquisition Date and the final fair value analysis, which is expected to be complete no later than the second quarter of 2023. The information below reflects the preliminary amounts of identifiable assets acquired and liabilities assumed as of the Acquisition Date (in thousands): Amount Assets: Inventory $ 11,152 Property and equipment 2,921 Goodwill 3,067 Intangible asset - Developed technology 1,200 Operating lease right-of-use assets 1,812 Total assets 20,152 Liabilities: Liabilities assumed 2,631 Operating lease liability 1,812 Total liabilities 4,443 Net assets acquired $ 15,709 Inventory of $ 11.2 million consisted of raw materials, semi-finished goods and finished goods. The fair value of the inventory was determined based on the estimated selling price to be generated from the finished goods, less costs to sell, including a reasonable margin, which are level 3 inputs not observable in the market. Property and equipment and assumed liabilities were recorded at their carrying amounts which were deemed to approximate their fair values based on level 3 unobservable inputs. The fair values of the right-of-use assets and lease liabilities for assumed operating leases were assessed in accordance with ASC Topic 842, Leases , based on discounted cash flow from lease payments, utilizing the Company’s incremental borrowing rate of 7.25 %. The fair value of the intangible asset was determined by applying the income approach based on significant level 3 unobservable inputs. The income approach estimates fair value based on the present value of cash flow that the assets could be expected to generate in the future. We developed internal estimates for expected cash flows in the present value calculation using inputs and significant assumptions that include historical revenues and earnings, long-term growth rate, discount rate, contributory asset charges and future tax rates, among others. 17 The fair value of the contingent milestone liability was estimated using the Monte Carlo simulation method for the calculation of the potential payment and the Geometric Brownian Motion forecasting model to estimate the underlying revenue. Market based inputs and other level 3 inputs were used to forecast future revenue. The key inputs used included a risk-free rate of 2.95 %, dividend yield of 0 %, volatility of 65 %, period of 15 years and credit risk of 12 %. The Company incurred acquisition-related costs of approximately $ 0.2 million and $ 0.4 million for the three and nine months ended September 30, 2022, respectively. Supplemental Pro Forma Information (unaudited) Net r evenue for the three and nine months ended September 30, 2022 was $ 5.4 million and $ 7.5 million, respectively, and loss from operations for the three and nine months ended September 30, 2022 was $ 0.2 million and $ 0.1 million, respectively, since the Acquisition Date. The following unaudited pro forma summary presents consolidated information of the Company as if the acquisition had occurred on January 1, 2021 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net revenue $ 30,752 $ 28,087 $ 73,874 $ 79,665 Net loss ( 14,124 ) ( 4,264 ) ( 69,020 ) ( 53,005 ) Net loss per share - basic and diluted $ ( 0.05 ) $ ( 0.02 ) $ ( 0.27 ) $ ( 0.21 ) These pro forma amounts have been calculated by applying the Company’s accounting policies assuming transaction costs had been incurred beginning January 1, 2021. The Company did not have any other material nonrecurring pro forma adjustments directly attributable to the acquisition included in the reported pro forma revenue and loss. 3. Investments Held-to-Maturity Investments — Investments consist of highly liquid investments that are intended to facilitate liquidity and capital preservation. As of September 30, 2022, the Company held $ 110.7 million of short-term investments and $ 12.7 million of long-term investments. As of December 31, 2021, the Company held $ 79.9 million of short-term investments and $ 56.6 million of long-term investments. For the three and nine months ended September 30, 2022, the Company recognized $ 0.7 million and $ 1.6 million of interest income on investments and $ 0.2 million and $ 0.6 million of amortization on certain investments. The interest income net of amortization on investments is reflected as interest income, net on the condensed consolidated statement of operations. For the three and nine months ended September 30, 2021, the Company recognized a de minimis amount of interest income on investments. No allowance for credit losses on held-to-maturity securities was required as of September 30, 2022. Available-for-Sale Investment — The Thirona convertible notes are classified as available-for-sale securities and are 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. The Company evaluated the fair value of its investment in Thirona as of September 30, 2022 by applying a Monte Carlo simulation and determined that the fair value was $ 6.8 million. The fair value of the investment in Thirona as of December 31, 2021 was $ 3.0 million, which approximated carrying value. For the nine months ended September 30, 2022, an unrealized holding loss of $ 1.2 million was recognized as other comprehensive loss in our condensed consolidated statements of comprehensive loss and condensed consolidated statements of stockholders’ deficit. The fair value of the cash equivalents, long-term and short-term investments are disclosed below (amounts in millions). September 30, 2022 Investment Level Amortized Cost (Carrying Value) Gross Unrealized Holding Losses Estimated Fair Value Commercial bonds and paper Level 2 $ 81.7 $ ( 0.9 ) $ 80.8 Money market funds Level 1 43.4 — 43.4 U.S. Treasuries Level 2 42.8 ( 0.8 ) 42.0 Total cash equivalents and investments 167.9 ( 1.7 ) 166.2 Less cash equivalents ( 44.4 ) — ( 44.4 ) Total Investments $ 123.5 $ ( 1.7 ) $ 121.8 18 December 31, 2021 Investment Level Amortized Cost (Carrying Value) Gross Unrealized Holding Losses Estimated Fair Value Commercial bonds and paper Level 2 $ 115.2 $ 0.2 $ 115.0 Money market funds Level 1 21.3 — 21.3 U.S. Treasuries Level 2 23.9 0.1 23.8 Total cash equivalents and investments 160.4 0.3 160.1 Less cash equivalents ( 23.8 ) — ( 23.8 ) Total Investments $ 136.6 $ 0.3 $ 136.3 As of September 30, 2022 and December 31, 2021, there was $ 0.6 million and $ 0.3 million, respectively, of interest receivable included in our condensed consolidated balance sheets as prepaid expenses and other current assets. 4. Accounts Receivable Accounts receivable, net consists of the following (in thousands): September 30, 2022 December 31, 2021 Accounts receivable – commercial Accounts receivable, gross $ 22,971 $ 7,939 Wholesaler distribution fees and prompt pay discounts ( 2,863 ) ( 1,696 ) Reserve for returns ( 3,135 ) ( 2,797 ) Total accounts receivable – commercial, net 16,973 3,446 Accounts receivable – collaborations and services Accounts receivable, gross 6,520 2,060 Allowance for doubtful accounts — ( 767 ) Total accounts receivable – collaborations and services, net 6,520 1,293 Total accounts receivable, net $ 23,493 $ 4,739 As of September 30, 2022 and December 31, 2021, the allowance for doubtful accounts for accounts receivable – commercial was de minimis . The Company had three wholesale distributors representing approximately 78 % of commercial accounts receivable as of September 30, 2022 and approximately 75 % and 73 % of gross sales for the three and nine months ended September 30, 2022, respectively. As of December 31, 2021, the Company had three wholesale distributors representing approximately 79 % of commercial accounts receivables and approximately 80 % of gross sales. As of September 30, 2022, there was no allowance for credit losses for accounts receivable – collaborations and services. The Company had one collaboration partner, United Therapeutics, that comprised 100 % of the collaboration and services net accounts receivable as of September 30, 2022 and approximately 100 % and 96 % of gross revenue from collaborations and services for the three and nine months ended September 30, 2022, respectively. 5. Inventories Inventories consist of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 5,535 $ 2,703 Work-in-process 8,235 2,522 Finished goods 4,503 1,927 Total inventory $ 18,273 $ 7,152 Work-in-process and finished goods as of September 30, 2022 and December 31, 2021 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 September 30, 2022 and December 31, 2021, which consisted of FDKP received in November 2019. The Company expects to request approval from the FDA for the new source of FDKP in 2023. 19 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 at September 30, 2022 and December 31, 2021. Inventory that was forecasted to become obsolete due to expiration as well as inventory that does not meet acceptable standards is recorded in costs of goods sold in the condensed consolidated statements of operations. T here was an inventory write-off of $ 0.9 million and $ 1.4 million as a result of this assessment for the three and nine months ended September 30, 2022, respectively. There were no inventory write-offs for the three and nine months ended September 30, 2021. 6. Property and Equipment Property and equipment consists of the following (dollars in thousands): Estimated Useful Life (Years) September 30, 2022 December 31, 2021 Land — $ 875 $ 875 Buildings 39-40 17,389 17,389 Building improvements 3-40 38,875 38,651 Machinery and equipment 1-15 59,349 55,334 Furniture, fixtures and office equipment 3-10 2,976 2,969 Computer equipment and software 3 8,445 8,163 Construction in progress — 12,395 10,892 (1) 140,304 134,273 Less accumulated depreciation ( 99,122 ) ( 97,661 ) Total property and equipment, net $ 41,182 $ 36,612 _________________________ (1) As of December 31, 2021 , c onstruction in progress included $ 4.7 million of equipment under construction for the manufacturing expansion for UT (the “UT Equipment”). See Note 10 – Collaboration, Licensing and Other Arrangements. The Company acted as agent on behalf of UT for the procurement of the UT Equipment. The Company received $ 5.0 million in deposit for this service, which was recognized as deposits from customer in the condensed consolidated balance sheet as of December 31, 2021. In April 2022, the Company and UT agreed that UT would hold title to the UT Equipment at all times. As such, there is no balance related to the UT Equipment included in construction in progress or deposit from customer in our consolidated condensed balance sheet as of September 30, 2022. Depreciation expense related to property and equipment for the three and nine months ended September 30, 2022 and 2021 was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Depreciation Expense $ 952 $ 508 $ 2,278 $ 1,449 On November 8, 2021 , the Company sold certain land, building and improvements located in Danbury, CT (the “Property”) to an affiliate of Creative Manufacturing Properties (the “Purchaser”) for a sales price of $ 102.3 million, subject to terms and conditions contained in a purchase and sale agreement. Effective with the closing of this transaction, the Company entered into a 20 -year lease agreement with the Purchaser (the “Sale-Leaseback Transaction”) . The sale of the Property and subsequent lease did not result in the transfer of control of the Property to the Purchaser; therefore, the Sale-Leaseback Transaction qualified as a failed sale leaseback transaction whereby the lease is accounted for as a finance lease and the Property remains as a long-lived asset of the Company and is depreciated at its remaining useful life of 20 years or less. See Note 13 – Commitments and Contingencies . 7. Goodwill and Other Intangible Asset Goodwill — Goodwill represents the excess of the purchase price over the identifiable tangible and intangible assets acquired plus liabilities assumed arising from business combinations. The balance of goodwill was approximately $ 3.1 million as of September 30, 2022 as a result of our acquisition of V-Go in May 2022. Goodwill is tested at least annually for impairment by assessing qualitative factors in determining whether it is more likely than not that the fair value of net assets is below their carrying amounts. See Note 1 – Description of Business and Significant Accounting Policies . 20 Other Intangible Asset — Other intangible asset consisted of the following (dollars in thousands): Estimated Useful September 30, 2022 Life (Years) Cost Accumulated Amortization Net Book Value Developed technology 15 $ 1,200 $ ( 31 ) $ 1,169 Amortization expense related to the other intangible asset was de minimis for the three and nine months ended September 30, 2022. The Company evaluates its other intangible asset for potential impairment when events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. See Note 1 – Description of Business and Significant Accounting Policies . 8. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities were comprised of the following (in thousands): September 30, 2022 December 31, 2021 Salary and related expenses $ 11,627 $ 14,022 Discounts and allowances for commercial product sales 10,728 4,227 Danbury facility buildout 1,362 786 Deferred lease liability 1,339 1,380 Current portion of milestone rights liability 924 1,088 Professional fees 636 895 Accrued interest 754 2,166 Retail inventory purchase 4 875 Other 2,976 1,980 Accrued expenses and other current liabilities $ 30,350 $ 27,419 9 . Borrowings Carrying amount of borrowings consist of the following (in thousands): September 30, 2022 December 31, 2021 Senior convertible notes $ 225,034 $ 223,944 MidCap credit facility 39,155 38,833 Mann Group convertible note 8,829 18,425 Total debt — net carrying amount $ 273,018 $ 281,202 The following table provides a summary of the Company’s principal balance of debt and key terms: Amount Due Terms September 30, 2022 December 31, 2021 Annual Interest Rate Maturity Date Conversion Price Senior convertible notes $ 230.0 million $ 230.0 million 2.50 % March 2026 $5.21 per share MidCap credit facility (1) $ 40.0 million $ 40.0 million one-month SOFR (1% floor) plus 6.25%; cap of 8.25% (1 ) August 2025 (1 ) N/A Mann Group convertible note $ 8.8 million $18.4 million (plus $0.4 million accrued interest paid-in-kind) 2.50 % (2 ) December 2025 (2 ) $2.50 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 . 21 In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). The interest rate prior to the amendment was one-month LIBOR ( 1 % floor) plus 6.25 % (cap of 8.25 %). (2) In April 2021, the Mann Group convertible note was amended. The interest rate prior to and after the amendment was 7.00 % and the maturity date was in November 2024 . The maturities of the Company’s borrowings as of September 30, 2022 are as follows (in thousands): Amounts 2022 $ — 2023 6,667 2024 20,000 2025 22,163 Thereafter 230,000 Total principal payments 278,830 Unamortized discount ( 269 ) Debt issuance costs ( 5,543 ) Total debt — net carrying amount $ 273,018 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 common stock or a combination of cash and shares of common stock, at the Company’s election, in the manner and subject to the terms and conditions provided in the Indenture. The initial conversion rate is 191.8281 shares of common stock per $ 1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $ 5.21 per share of common stock). The initial conversion price of the Senior convertible notes represents a premium of approximately 30 % to the last reported sale price of the common stock on the Nasdaq Global Market on March 1, 2021. The conversion rate for the Senior convertible notes is subject to adjustment under certain circumstances in accordance with the terms of the Indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date of the Senior convertible notes or if the Company delivers a notice of redemption in respect of the Senior convertible notes, the Company will, in certain circumstances, increase the conversion rate of the Senior convertible notes for a holder who elects to convert its Senior convertible notes in connection with such a corporate event or convert its Notes called for redemption during the related redemption period (as defined in the Indenture), as the case may be. The Company may not redeem the Senior convertible notes prior to March 6, 2024 . The Company may redeem for cash all or any portion of the Senior convertible notes, at its option, on or after March 6, 2024 and prior to the 36th scheduled trading day immediately preceding the maturity date, if the last reported sale price of common stock has been at least 130 % of the conversion price for the Senior convertible notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the 22 date on which the Company provides notice of redemption at a redemption price equal to 100 % of the principal amount of the Senior convertible notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If the Company elects to redeem less than all of the outstanding Senior convertible n otes, at least $ 75.0 million aggregate principal amount of Senior convertible n otes must be outstanding and not subject to redemption as of the relevant redemption notice date. No sinking fund is provided for the Senior convertible notes . If the Company undergoes a fundamental change (as defined in the Indenture), then, subject to certain conditions and except as described in the Indenture, holders may require the Company to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100 % of the principal amount of the Senior convertible notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The Indenture includes customary covenants and sets forth certain events of default after which the Senior convertible notes may be declared immediately due and payable. If certain bankruptcy and insolvency-related events of default involving the Company (and not just any of its significant subsidiaries) occur, 100 % of the principal of and accrued and unpaid interest on the Senior convertible notes will automatically become due and payable. If an event of default with respect to the Senior convertible notes, other than certain bankruptcy and insolvency-related events of default involving the Company (and not just any of its significant subsidiaries), occurs and is continuing, the trustee, by notice to the Company, or the holders of at least 25% in principal amount of the outstanding Senior convertible notes by notice to the Company and the trustee, may, and the trustee at the request of such holders shall, declare 100 % of the principal of and accrued and unpaid interest, if any, on all the Senior convertible notes to be due and payable. Notwithstanding the foregoing, the Indenture provides that, to the extent the Company so elects, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture will, for the first 365 days after the occurrence of such an event of default consist exclusively of the right to receive additional interest on the Senior convertible notes as set forth in the Indenture . The Indenture provides that the Company shall not consolidate with or merge with or into, or sell, convey, transfer or lease all or substantially all of the consolidated properties and assets of the Company and its subsidiaries, taken as a whole, to, another person (other than any such sale, conveyance, transfer or lease to one or more of the Company’s direct or indirect wholly owned subsidiaries), unless: (i) the resulting, surviving or transferee person (if not the Company) is a corporation organized and existing under the laws of the United States of America, any State thereof or the District of Columbia, and such corporation (if not the Company) expressly assumes by supplemental indenture all of the Company’s obligations under the Senior convertible notes and the Indenture; and (ii) immediately after giving effect to such transaction, no default or event of default has occurred and is continuing under the Indenture. The Company’s net proceeds from the 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 September 30, 2022, the unamortized debt issuance cost was $ 5.0 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”) became available to the Company after the Tyvaso DPI approval by the FDA through June 30, 2022 (see Note 10 – Collaboration, Licensing and Other Arrangements ). The Company did not exercise its right to borrow Tranche 3. The MidCap credit facility has been amended several times, including in April 2021 when the parties agreed to, among other things, (i) increase the amount available under the third advance from $ 25.0 million to $ 60.0 million and extend the date through which the third advance is available to June 30, 2022 , (ii) amend the conditions to the third advance of $60.0 million being available to draw, including certain milestone conditions associated with Tyvaso DPI, (iii) remove the Company’s obligation to issue a warrant to purchase shares of the Company’s common stock upon drawing down the third advance, (iv) extend the interest-only period until September 1, 2023 and extend the maturity date until August 1, 2025 , (v) amend the financial covenant relating to trailing 12 month minimum Afrezza net revenue, (vi) decrease the minimum cash covenant, (vii) decrease the interest rate on any amounts outstanding, now or in the future, under the MidCap credit facility, (viii) permit the Company to make certain acquisitions, subject to requirements, and (ix) permit the Company to make investments of up to an additional $ 9.0 million so long as the Company has $ 90.0 million or more of unrestricted cash and short-term investments following such investment. Concurrent with entering into this amendment, the Company made a $ 10.0 million principal prepayment against outstanding term loans under the MidCap credit facility and paid a related $ 1.0 million exit fee in lieu of the unaccrued portion of the original exit fee and prepayment penalties that would otherwise have been due with respect to the partial prepayment. The prepayment penalty of $ 1.0 million related to the payment of $ 10.0 million was capitalized and will be amortized over the remaining life of the debt. As of September 30, 2022, the unamortized debt discount was $ 0.3 million and the unamortized prepayment penalty was $ 0.6 million. 23 In August 2022, the Company entered into the tenth amendment to the MidCap credit facility to change the benchmark interest rate from LIBOR to the Secured Overnight Financing Rate (“SOFR”). Tranche 1 and Tranche 2 accrue interest at an annual rate equal to the lesser of (i) 8.25 % and (ii) the one-month SOFR (subject to a one-month SOFR floor of 1.00 %) plus 6.25 %. Interest on each term loan advance is due and payable monthly in arrears. Principal on each term loan advance under Tranche 1 and Tranche 2 are payable in 24 equal monthly installments 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. The Company’s obligations under the MidCap credit facility are secured by a security interest on substantially all of its assets, including intellectual property. The MidCap credit facility, as amended, contains customary affirmative covenants and customary negative covenants limiting the Company’s ability and the ability of the Company’s subsidiaries to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions. The Company must also comply with a financial covenant relating to trailing twelve month minimum Afrezza net revenue, tested on a monthly basis, unless the Company has $ 90.0 million or more of unrestricted cash and short-term investments. As of September 30, 2022, the Company was in compliance with the financial 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 %. 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 originally accrued interest at the rate of 7.00 % per year on the principal amount, payable quarterly in arrears on the first day of each calendar quarter beginning October 1, 2019 . In April 2021, the Company repaid the entire principal amount of $ 35.1 million outstanding under the Mann Group non-convertible note, together with all accrued and unpaid interest thereon. On the same date, the Company and Mann Group amended the Mann Group convertible note, pursuant to which the parties agreed to (i) reduce the interest rate from 7.0% to 2.5 % effective on April 22, 2021, and (ii) extend the maturity date from November 3, 2024 to December 31, 2025 . The amendment to the Mann Group convertible note resulted in a debt extinguishment with a substantial premium based on the fair value post extinguishment. The fair value in excess of the face amount of $ 18.4 million contributed to a loss on extinguishment of $ 22.1 million in the consolidated statement of operations for the year ended December 31, 2021 and resulted in a corresponding debt premium of $ 22.1 million which was recognized as additional paid-in capital in the consolidated balance sheet as of December 31, 2021. The accounting for the $22.1 million loss on extinguishment did not result in a change in the financial position of the Company. The Company wrote off a de minimis amount of debt issuance cost. The principal and any accrued and unpaid interest under the Mann Group convertible note may be converted, at the option of Mann Group, at any time on or prior to the close of business on the business day immediately preceding the stated maturity date, into shares of the Company’s common stock at a conversion rate of 400 shares per $ 1,000 of principal and/or accrued and unpaid interest, which is equal to a conversion price of $ 2.50 per share. The conversion rate will be subject to adjustment under certain circumstances described in the Mann Group convertible note. Interest on the convertible note will be payable in kind by adding the amount thereof to the principal amount; provided that with respect to interest accruing from and after January 1, 2021, the Company may, at its option, elect to pay any such interest on any interest payment date, if certain conditions are met, in shares of the Company’s common stock at a price per shall equal to the last reported sale price on the trading day immediately prior to the payment date. During the nine months ended September 30, 2022, Mann Group converted $ 10.0 million of principal and capitalized interest into 4,000,000 shares of common stock. In addition, the Company paid $ 0.2 million of interest by issuing the Mann Group 57,491 shares of common stock. 24 During the nine months ended September 30, 2021, Mann Group converted $ 0.4 million of interest and $ 9.6 million of principal into 4,000,000 shares of common stock . Amortization of debt discount and debt issuance cost related to all borrowings for the three and nine months ended September 30, 2022 and 2021 were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Amortization of debt discount $ 108 $ 109 $ 321 $ 255 Amortization of debt issuance cost 363 363 1,089 852 Milestone Rights — As of September 30, 2022 and December 31, 2021, the remaining Milestone Rights liability balance was $ 4.8 million and $ 5.9 million, respectively, which was based on initial fair value estimates calculated using the income approach and reduced by milestone achievement payments made. As of December 31, 2021, the $5.9 million liability consisted of a $ 1.1 million current liability which was presented as accrued expenses and other current liabilities and a $ 4.8 million long-term liability which was presented in milestone liabilities in our condensed consolidated balance sheets. As of September 30, 2022, the $4.8 million liability consisted of a $ 0.9 million current liability which was presented as accrued expenses and other current liabilities and a $ 3.9 million long-term liability which was presented in milestone liabilities in our condensed consolidated balance sheets. During the second quarter of 2022, the Company achieved an Afrezza net sales milestone specified by the Milestone Rights. The carrying value of the Milestone Rights liability related to the $ 5.0 million payment, which was made in the third quarter of 2022, was approximately $ 1.1 million and represented the fair value as determined in 2013 (the most recent measurement date). The Milestone Rights Agreement includes customary representations and warranties and covenants by the Company, including restrictions on transfers of intellectual property related to Afrezza. The Milestone Rights are subject to acceleration in the event the Company transfers its intellectual property related to Afrezza in violation of the terms of such agreement. 10. Collaboration, Licensing and Other Arrangements Revenue from collaborations and services for the three and nine months ended September 30, 2022 and 2021 are as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 UT CSA Agreement (1) $ 9,916 $ — $ 15,795 $ — UT License Agreement (2) 393 12,313 1,949 33,475 Vertice Pharma Co-Promotion Agreement — — 325 1,147 Cipla License and Distribution Agreement 37 37 110 110 Other — 77 200 161 Receptor CLA — 31 1 206 Total revenue from collaborations and services $ 10,346 $ 12,458 $ 18,380 $ 35,099 _________________________ (1) Amount consists of revenue recognized for Manufacturing Services and sales of product to UT for the periods presented. (2) Amounts consist of revenue recognized for Next-Gen R&D Services and R&D Services and License for the periods presented. 25 United Therapeutics License Agreement — In September 2018, the Company and UT entered into an exclusive global license and collaboration agreement (the “UT License Agreement”), pursuant to which UT is responsible for global development, regulatory and commercial activities with respect to Tyvaso DPI. The Company is responsible for the manufacturing of Tyvaso DPI. Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 UT Revenue (in thousands) UT CSA Agreement $ 9,916 $ — $ 15,795 $ — UT License Agreement 393 12,313 1,949 33,475 Royalties — Collaborations (1) 6,220 — 6,524 — Total revenue from UT $ 16,529 $ 12,313 $ 24,268 $ 33,475 _________________________ (1) Amount consists of royalties associated with the UT license Agreement. The current portion of contract assets related to the royalties is included in prepaid expense and other current assets in the condensed consolidated balance sheets . 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 is also 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. In August 2021, the Company and UT entered into a CSA, pursuant to which the Company is responsible for manufacturing and supplying to United Therapeutics, and United Therapeutics is responsible for purchasing from the Company on a cost-plus basis, Tyvaso DPI and BluHale inhalation profiling devices, as required for commercial distribution and sale by UT. In addition, UT is responsible for supplying treprostinil at its expense in quantities necessary to enable the Company to manufacture Tyvaso DPI as required by the CSA. Pursuant to the CSA, UT is obligated to reimburse certain pre-production costs incurred by the Company to support the manufacturing and supply of Tyvaso DPI. The activities and deliverables under the CSA and the current development plan resulted in three distinct performance obligations which include: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI (“R&D Services and License”); (2) development activities for the next generation of Next-Gen R&D Services; and (3) a material right associated with future commercial manufacturing and supply of product (“Manufacturing Services”). Following the FDA’s approval of Tyvaso DPI, UT began issuing the Company purchase orders for the supply of product, which represents distinct contracts and performance obligations under ASC 606. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT. The term of the CSA continues until December 31, 2031 (unless earlier terminated) and is thereafter renewed automatically for additional, successive two-year terms unless (i) UT provides notice to the Company at least 24 months in advance of such renewal that UT does not wish to renew the CSA or (ii) the Company provides notice to UT at least 48 months in advance of such renewal that the Company does not wish to renew the CSA. The Company and UT each have normal and customary termination rights, including termination for material breach that is not cured within a specific timeframe or in the event of liquidation, bankruptcy or insolvency of the other party. 26 The Company accounted for the contract modification as if it were part of the existing contract since the amendment modified the scope and price of the CSA by extending the term and increasing the occupancy rate. The effect of the modification on the transaction price and on the measure of progress is recognized as an adjustment to revenue as of the date of the modification. The modification did not result in a change to the activities and deliverables under the CSA. Anticipated Description Cash Flow Revenue Allocation (1) Recognition Method Progress Measure Revenue Recognition (in millions) Total anticipated cash flow (2) $ 463.5 Distinct Performance Obligation R&D Services and License (3) $ — Over time Ratably Aug 2021 - Oct 2021 (4) Next-Gen R&D Services (5) $ 4.8 Over time Input % of completion of costs (6) Manufacturing Services (7) $ 458.7 Point in time Transfer of control (8) _________________________ (1) Allocation is based on management’s assessment of the stand-alone selling price of each performance obligation. (2) The total anticipated cash flow includes a transaction price of $ 64.3 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $ 399.2 million for future supply of Tyvaso DPI over the remaining term of the CSA. (3) The license for the Company’s IP was considered to be interdependent with the development activities to support approval of Tyvaso DPI. A sales-based royalty is promised in exchange for the IP license; therefore, the royalties associated with the license are excluded from the determination of the transaction price and the Company will recognize revenue as the sale of Tyvaso DPI to a patient occurs. (4) Represents the period when the revenue for the R&D Services performance obligation was recognized. (5) The standalone selling price (“SSP”) for the Next-Gen R&D Services performance obligation was based on industry ratios as well as the Company’s historical R&D projects. The transaction price for the Next-Gen R&D Services was based on fixed consideration which was allocated between performance obligations as discussed in note (2) above. (6) The Next-Gen R&D Services performance obligation 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. (7) Pre-production activities under the CSA, such as facility expansion services and certain other administrative services, were considered bundled services that are part of the Company’s Manufacturing Services performance obligation, given the nature of the Company’s contractual responsibilities and ASC 606 requirements. (8) The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $ 144.5 million . The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The ultimate cash flows may vary as manufacturing purchase orders are received. In April 2022, the Company and UT agreed to fund $ 2.3 million in capital improvements to support commercialization and continuous improvement activities and $ 0.7 million in the development of alternative manufacturing processes. The Company determined that the capital improvements and continuous improvements should be combined with the manufacturing services performance obligation and the alternative manufacturing processes should be combined with the Next-Gen R&D Services. Anticipated Description Cash Flow Revenue Allocation Recognition Method Progress Measure Revenue Recognition (in millions) Total anticipated cash flow (1) $ 483.2 Distinct Performance Obligation R&D Services and License $ — Over time Ratably Aug 2021 - Oct 2021 Next-Gen R&D Services $ 5.9 Over time Input % of completion of costs Manufacturing Services and Product Sales (2) $ 477.2 Point in time Transfer of control _________________________ Notes presented in the previous modification table above also apply to this modification table unless noted otherwise. (1) The total anticipated cash flow includes a transaction price of $ 71.5 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $ 411.7 million for future supply of Tyvaso DPI over the remaining term of the CSA. 27 (2) The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $ 150.2 million . The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The ultimate cash flows may vary as manufacturing purchase orders are received. As of September 30, 2022, deferred revenue consisted of $ 32.2 million, of which $ 1.6 million was classified as current and $ 30.6 million was classified as long-term 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 pursuant to which the Company’s sales force promoted Thyquidity to adult endocrinologists, pediatric endocrinologists and other healthcare providers who treat hypothyroidism. Following the commercial launch of Thyquidity in February 2021, Vertice Pharma became obligated to pay fixed quarterly payments to the Company, as well as variable consideration based on gross profits resulting from all sales of Thyquidity. In September 2021, the Company and Vertice Pharma mutually agreed that the Company would cease promotional activities under the co-promotion agreement effective September 30, 2021, other than certain transitional activities that continued until October 15, 2021. As of December 31, 2021, the Company had fully reserved $ 0.8 million of revenue from the co-promotion of Thyquidity, which was recognized as allowance for credit losses and was included in accounts receivable, net in the condensed consolidated balance sheet. In June 2022, the Company and Vertice Pharma reached a final settlement of all obligations related to the termination of the co-promotion agreement of $ 0.3 million, which was recognized as revenue from collaboration and services in the Company’s condensed consolidated statement of operations and the balance was written off against the reserve. 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 research and development 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 were received. Biomm commenced product sales in January 2020. There were no shipments of product to Biomm in 2021 or the first nine months of 2022. Cipla License and Distribution Agreement — In May 2018 , the Company and Cipla Ltd. (“Cipla”) entered into an exclusive agreement for the marketing and distribution of Afrezza in India and the Company received a $ 2.2 million nonrefundable license fee. Under the terms of the agreement, Cipla is responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla. The Company has the potential to receive an additional regulatory milestone payment, minimum purchase commitment revenue and royalties on Afrezza sales in India once cumulative gross sales have reached a specified threshold. The nonrefundable licensing fee was recorded in deferred revenue and is being recognized in net revenue – collaborations over 15 years, representing the estimated period to satisfy the performance obligation. The additional milestone payments represent variable consideration for which the Company has not recognized any revenue because of the uncertainty of obtaining marketing approval. As of September 30, 2022, the deferred revenue balance was $ 1.6 million, of which $ 0.2 million is classified as current and $ 1.4 million is classified as long term in the condensed consolidated balance sheets. 11. 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 28 price method for estimating the fair value of loans for disclosure purposes. Inputs used in the valuation techniques to derive fair values are classified based on a three-level hierarchy, as follows: Level 1 — Quoted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 — Significant inputs to the valuation model are unobservable. The carrying amounts reported in the condensed consolidated financial statements for cash, accounts receivable, accounts payable, and accrued expenses and other current liabilities (excluding the Milestone Rights liability) approximate their fair value due to their relatively short maturities. The fair value of the cash equivalents, long- and short-term investments, MidCap credit facility, Mann Group promissory note, 2024 convertible notes, Senior convertible notes, Milestone Rights liabilities and Financing liability are disclosed below. Cash Equivalents — Cash equivalents consist of highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase that are readily convertible into cash. As of September 30, 2022 and December 31, 2021, the Company held $ 54.3 million and $ 124.2 million, respectively, of cash and cash equivalents. 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): September 30, 2022 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (1) $ 225.0 $ 206.1 $ 206.1 MidCap credit facility (2) 39.2 40.7 40.7 Mann Group convertible note (3) 8.8 13.3 13.3 Milestone rights (4) 4.8 13.0 13.0 Contingent milestone liability (4) 0.6 0.8 0.8 _________________________ (1) Fair value determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 13 %, volatility of 74.7 % and a Monte Carlo simulation for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 196.8 million and $ 216.2 million, respectively. (2) Fair value determined by applying a discounted cash flow analysis with a hypothetical yield of 12 %. A change in yield of + or – 2 % would result in a fair value of $ 39.5 million and $ 42.1 million, respectively. (3) The fair value assessed as of September 30, 2022 was determined by applying a discounted cash flow analysis with a hypothetical yield of 13 % and volatility of 75.8 % to the straight note and a binomial option pricing model for the value of the conversion feature. A change in yield of + or – 2 % would result in a fair value of $ 12.9 million and $ 13.7 million, respectively. (4) Fair value determined by applying a Monte Carlo simulation. December 31, 2021 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (1) $ 223.9 $ 237.5 $ 237.5 MidCap credit facility (2) 38.8 40.8 40.8 Mann Group convertible note (3) 18.4 37.8 37.8 Milestone rights (4) 5.9 18.1 18.1 _________________________ (1) Fair value determined by applying a discounted cash flow analysis to the straight note with a hypothetical yield of 12 %, volatility of 90 % 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 $ 226.6 million and $ 249.4 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 $ 39.1 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 December 31, 2021. The accounting for the $ 22.1 million loss on extinguishment did not result in a change in the financial position of the Company. The fair value assessed as of December 31, 2021 was determined by applying a discounted cash flow analysis with a hypothetical yield of 12 % and volatility 29 of 85 % 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 $ 36.9 million and $ 38.8 million, respectively. (4) Fair value determined by applying a Monte Carlo simulation. Milestone Rights Liability — The fair value measurement of the Milestone Rights liability is sensitive to the discount rate and the timing of achievement of milestones. The Company utilized Monte-Carlo Simulation Method to simulate the Afrezza net sales under a neutral framework to estimate the payment. The Company then discounted the future expected payments at cost of debt with a term equal to the simulated time to payout based on cumulative sales. Contingent milestone liability — The acquisition of V-Go on May 31, 2022 resulted in a contingent milestone liability which could result in obligations to the seller if certain revenue thresholds are met. The initial fair value of the contingent milestone liability was recorded as an adjustment to the purchase price. Subsequent changes in the fair value are reported in selling, general and administrative expenses. Financing Liability — The Sale-Leaseback Transaction in November 2021 resulted in a financing liability which is included in our condensed consolidated balance sheets as a current financing liability of $ 9.5 million and a long-term financing liability of $ 94.5 million. The fair value of $ 103.2 million was determined using level 3 inputs. As of September 30, 2022, the fair value was determined using a discounted cash flow analysis with a hypothetical yield of 10 %. As of December 31, 2021, the Company evaluated the fair value of its financing liability and determined that the fair value approximated the carrying value . 12. Common and Preferred Stock 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 September 30, 2022 and December 31, 2021, 263,156,165 and 251,477,562 shares of common stock, respectively, were issued and outstanding and no shares of preferred stock were outstanding. In February 2018 , the Company entered into a controlled equity offering sales agreement (the “CF Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), as sales agent, pursuant to which the Company may offer and sell, from time to time, through Cantor Fitzgerald, shares of the Company’s common stock having an aggregate offering price of up to $ 50.0 million or such other amount as may be permitted by the Sales Agreement. Under the Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act of 1933, as amended. For the nine months ended September 30, 2022, the Company sold 5,059,856 shares of common stock at a weighted average purchase price of $ 3.91 per share for gross proceeds of approximately $ 19.8 million pursuant to the CF Sales Agreement. For the nine months ended September 30, 2021, the Company sold 578,063 shares of the Company’s common stock at a weighted average purchase price of $ 3.26 per share for gross proceeds of approximately $ 1.9 million pursuant to the CF Sales Agreement. In the second quarter of 2022, Mann Group converted $ 10.0 million of principal and capitalized interest into 4,000,000 shares of common stock. In addition, the Company paid quarterly interest by issuing Mann Group 31,541 shares of common stock. In the third quarter of 2022, the Company paid quarterly interest by issuing Mann Group 25,950 shares of common stock. For the nine months ended September 30, 2022, the Company received $ 0.7 million from the market price stock purchase plan (“MPSPP”) for 252,176 shares. The Company received $ 0.1 million from the MPSPP for 25,000 shares during the three and nine months ended September 30, 2021. For shares of common stock issued pursuant to the ESPP, see Note 14 – Stock-Based Compensation Expense. 13. 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. 30 The following tables summarize the components of the basic and diluted EPS computations (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 EPS — basic and diluted: Net loss (numerator) $ ( 14,432 ) $ ( 4,426 ) $ ( 69,453 ) $ ( 52,865 ) Weighted average common shares (denominator) 259,300 249,910 254,974 248,624 Net loss per share $ ( 0.06 ) $ ( 0.02 ) $ ( 0.27 ) $ ( 0.21 ) 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): Nine Months Ended September 30, 2022 2021 Senior convertible notes 44,120,463 44,120,463 Mann Group convertible notes 3,370,000 7,370,000 Common stock options and PNQs 9,516,375 10,910,655 RSUs and Market RSUs (1) 14,784,399 7,564,632 Employee stock purchase plan 124,904 84,544 Warrants associated with MidCap credit facility — 1,283,467 Total shares 71,916,141 71,333,761 __________________________ (1) Market RSUs issued in 2020, 2021 and 2022 are included at the share delivery of 300 %, 0 % and 100 %, respectively, in accordance with a valuation assessment obtained as of September 30, 2022. 14. Stock-Based Compensation Expense During the nine months ended September 30, 2022, the Company granted the following awards (in shares): Three Months Ended Three Months Ended Three Months Ended Nine Months Ended March 31, 2022 June 30, 2022 September 30, 2022 September 30, 2022 Employee awards: RSUs 88,415 (1) 2,169,317 (2) 904,435 (5) 3,162,167 Market RSUs — 1,359,500 (3) — 1,359,500 Non-employee director RSUs — 360,360 (4) — 360,360 Total awards 88,415 3,889,177 904,435 4,882,027 _________________________ (1) RSUs had a weighted average grant date fair value of $ 2.72 per share, of which 12,800 RSUs had a cliff vesting period of three years and 75,615 RSUs had a vesting period of four years . (2) RSUs had a weighted average grant date fair value of $ 2.95 per share, of which 66,000 had a cliff vesting period of three years and 2,102,717 RSUs had a vesting period of four years . (3) Market RSUs had a grant date fair value of $ 6.10 per share and will vest on May 10, 2025 provided the closing price of the Company’s common stock on such vesting date is not less than the closing price on May 10, 2022. The number of shares delivered on the vesting date is determined by the percentile ranking of MannKind total shareholder return (TSR) over the period from May 10, 2022 until May 10, 2025 relative to the TSR of the Russell 3000 Pharmaceutical & Biotechnology Index over the same three-year period, as follows: less than 25th percentile= 0 % of target, 25th percentile= 50 % of target, 50th percentile= 100 % of target, 75th percentile= 200 % of target, 90th percentile or higher= 300 % maximum. Payout values will be interpolated between the percentile rankings above. (4) RSUs had a weighted average grant date fair value of $ 2.95 per share and vested immediately upon grant, but the underlying shares of common stock will not be delivered until there is a separation of service, such as resignation, retirement or death. ( 5 ) RSUs had a weighted average grant date fair value of $ 3.78 per share, of which 357,000 RSUs had a cliff vesting period of two years , 320,400 RSUs had a cliff vesting period of three years , and 227,035 RSUs had a vesting period of four years . 31 As of September 30, 2022, there was $ 0.9 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 2.07 years, and $ 16.2 million and $ 13.2 million of unrecognized stock-based compensation expense related to RSUs and Market RSUs, respectively, which is expected to be recognized over a weighted average period of approximately 2.71 and 1.56 years, respectively. Total stock-based compensation expense recognized in the condensed consolidated statements of operations as cost of goods sold, cost of revenue – collaborations and services, research and development and selling, general and administrative expense for the three and nine months ended September 30, 2022 and 2021 was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 RSUs and options $ 3,475 $ 2,983 $ 10,358 $ 8,628 Employee stock purchase plan 147 196 492 412 Total stock compensation expense $ 3,622 $ 3,179 $ 10,850 $ 9,040 Employee Stock Purchase Plan The Company provides all employees, including executive officers, the ability to purchase common stock at a discount under the Company’s 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 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 531,419 and 527,049 shares of common stock pursuant to the ESPP for the nine months ended September 30, 2022 and 2021, respectively. There were approximately 0.6 million shares of common stock available for issuance under the ESPP as of September 30, 2022. 15. 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 September 30, 2022, 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. Contingencies — In July 2013, the Company entered into the Milestone Rights Agreement with the Original Milestone Purchasers, pursuant to which the Company granted the Milestone Rights to receive payments up to $ 90.0 million upon the occurrence of specified strategic and sales milestones, $ 60.0 million of which remains payable to the Milestone Purchasers upon achievement of such milestones (see Note 9 – Borrowings ). As of September 30, 2022, the fair value of the Milestone Rights is recorded in the condensed consolidated balance sheet, including $ 0.9 million in accrued expenses and other current liabilities and $ 3.9 million in milestone liabilities. Sale-Leaseback Transaction — In November 2021, the Company sold the Property to the Purchaser for a sales price of $ 102.3 million, subject to terms and the conditions contained in a purchase and sale agreement. 32 Effective with the closing of the Sale-Leaseback Transaction, the Company and the Purchaser entered into a lease agreement (the “Lease”), pursuant to which the Company leased the Property from the Purchaser for an initial term of 20 years, with four renewal options of five years each. The total annual rent under the Lease starts at approximately $ 9.5 million per year, subject to a 50% rent abatement during the first year of the Lease, and will increase annually by (i) 2.5% in the second through fifth year of the Lease and (ii) 3% in the sixth and each subsequent year of the Lease, including any renewal term. The Company is responsible for payment of operating expenses, property taxes and insurance for the Property. The Purchaser will hold a security deposit of $ 2.0 million during the Lease term. Pursuant to the terms of the Lease, the Company has four options to repurchase the Property, in 2026, 2031, 2036 and 2041, for the greater of (i) $ 102.3 million and (ii) the fair market value of the Property. Effective with the closing of the Sale-Leaseback Transaction, the Company and the Purchaser also entered into a right of first refusal agreement (the “ROFR”), pursuant to which the Company has a right to re-purchase the Property from the Purchaser in accordance with terms and conditions set forth in the ROFR. Specifically, if the Purchaser receives, and is willing to accept, a bona fide purchase offer for the Property from a third-party purchaser, the Company has certain rights of first refusal to purchase the Property on the same material terms as proposed in such bona fide purchase offer. As of September 30 , 2022, the related financing liability was $ 104.0 million, which was recognized in our condensed consolidated balance sheet as $ 94.5 million of financing liability — long-term and $ 9.5 million of financing liability — short-term. As of December 31, 2021, the related financing liability was $ 100.5 million, which was recognized in our condensed consolidated balance sheet as $ 93.5 million of financing liability — long-term and $ 7.0 million of financing liability — short-term. Financing liability information is as follows: September 30, 2022 December 31, 2021 Weighted average remaining lease term (in years) 19.1 19.8 Weighted average discount rate 9.0 % 9.0 % Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Interest expense on financing liability $ 2,466 $ — $ 7,280 $ — Financing liability payments were as follows (in thousands): September 30, 2022 December 31, 2021 2022 $ 2,410 $ 6,373 2023 9,774 9,778 2024 10,018 10,023 2025 10,269 10,274 2026 10,533 10,539 Thereafter 199,302 199,091 Total 242,306 246,078 Interest expense ( 135,361 ) ( 142,485 ) Debt issuance costs ( 2,936 ) ( 3,091 ) Total financing liability $ 104,009 $ 100,502 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. 33 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 nine months ended September 30, 2021. The remaining purchase commitments as of September 30, 2022 were as follows: September 30, 2022 2022 € 1.3 million 2023 € 8.8 million 2024 € 14.6 million 2025 € 15.5 million 2026 € 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 term. The Company and Amphastar each have normal and customary termination rights, including termination for a material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, the Company may terminate the Insulin Supply Agreement upon two years’ prior written notice to Amphastar without cause or upon 30 days’ prior written notice to Amphastar if a controlling regulatory authority withdraws approval for Afrezza, provided, however, in the event of a termination pursuant to either of the latter two scenarios, the provisions of the Insulin Supply Agreement require the Company to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination. Vehicle Leases – During the second quarter of 2018, the Company entered into a master lease agreement with Enterprise Fleet Management Inc. During 2021, 85 vehicles were retired and replaced, resulting in a fleet size of 89 vehicles. The Company received proceeds for the gain on the retired vehicles residual value in the amount of $ 0.5 million, which is included as a reduction to our lease expense. The revised monthly payment inclusive of maintenance fees, insurance and taxes is approximately $ 0.1 million. 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 offices 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 expense is included in selling, general and administrative expenses in 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 offices in Westlake Village, California which was renewed in April 2022. Pursuant to the renewal, the Company will pay initial monthly payments of $ 79,543 , beginning in February 2023, subject to 3 % annual increases, plus the estimated cost of maintaining the property and common areas by the landlord. The Company will receive a six-month concession at the start of the lease extension period on July 31, 2023. The Company has no further right to extend the lease term beyond the Extension Period. The Company assumed certain leased real property (the “Marlborough Lease”) pursuant to the APA entered into in May 2022. The Marlborough Lease pertains to certain premises in a building located in Marlborough, Massachusetts. The Company will pay initial monthly payments of $ 28,895 , beginning in June 2022, subject to approximately 3 % annual increases through February 28, 2026. The Company also acquired rights to a manufacturing service agreement where V-Go are manufactured using Company-owned equipment located at the manufacturing facility. The Company determined that this arrangement results in an embedded lease which grants the Company exclusive use of space within the manufacturing facility. The Company assessed the embedded lease cost to be $ 14,370 per month through February 28, 2026. Lease information is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Operating lease costs $ 408 $ 323 $ 1,037 $ 1,008 Variable lease costs 76 128 235 359 Cash paid 441 451 1,328 1,367 34 September 30, 2022 December 31, 2021 Operating lease right-of-use assets (1) $ 7,046 $ 2,284 Weighted average remaining lease term (in years) 4.9 2.6 Weighted average discount rate 7.3 % 7.3 % _________________________ _________________________ _________________________ (1) Operating right-of-use assets related to vehicles, offices and the manufacturing facility are included in other assets in the condensed consolidated balance sheets. Future minimum office and vehicle lease payments as of September 30, 2022 and December 31, 2021, are as follows (in thousands): September 30, 2022 December 31, 2021 2022 $ 483 $ 1,444 2023 1,368 497 2024 1,892 409 2025 1,861 311 2026 1,140 — Thereafter 1,715 — Total $ 8,459 $ 2,661 16. 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 has not recognized a liability for unrecognized tax benefits. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months. The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. During the nine months ended September 30, 2022 the Company did no t recognize any interest or penalties. The Company’s tax years since 2017 remain subject to examination by tax authorities. 35