TANDEM DIABETES CARE INC 10-Q

Item 1. Financial Statements. TANDEM DIABETES CARE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except par value) September 30, December 31, 2024 2023 Assets (Unaudited) (Note 1) Current assets: Cash and cash equivalents $ 49,039 $ 58,868 Short-term investments 424,266 409,044 Accounts receivable, net 107,188 105,555 Inventories 152,441 157,937 Prepaid and other current assets 19,892 16,585 Total current assets 752,826 747,989 Property and equipment, net 81,064 76,542 Operating lease right-of-use assets 87,393 87,791 Other long-term assets 36,447 40,336 Total assets $ 957,730 $ 952,658 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 48,754 $ 49,586 Accrued expenses 12,280 12,726 Employee-related liabilities 58,718 43,430 Current portion of convertible senior notes, net 40,605 — Operating lease liabilities 18,033 17,060 Deferred revenue 42,567 43,994 Other current liabilities 38,319 28,462 Total current liabilities 259,276 195,258 Convertible senior notes, net - long-term 307,829 285,035 Operating lease liabilities - long-term 109,479 113,572 Deferred revenue - long-term 11,196 13,331 Other long-term liabilities 32,240 31,830 Total liabilities 720,020 639,026 Commitments and contingencies (Note 13) — — Stockholders’ equity: Common stock, $ 0.001 par value; 200,000 shares authorized, 65,646 and 65,552 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively. 66 66 Additional paid-in capital 1,282,354 1,263,997 Accumulated other comprehensive income 3,870 1,369 Accumulated deficit ( 1,048,580 ) ( 951,800 ) Total stockholders’ equity 237,710 313,632 Total liabilities and stockholders’ equity $ 957,730 $ 952,658 See accompanying notes to unaudited condensed consolidated financial statements. 1 TANDEM DIABETES CARE, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (Unaudited) (In thousands, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Sales $ 243,971 $ 185,622 $ 657,555 $ 550,922 Cost of sales 119,318 95,869 325,436 276,527 Gross profit 124,653 89,753 332,119 274,395 Operating expenses: Selling, general and administrative 99,639 79,328 283,987 266,752 Research and development 51,107 41,970 146,677 127,063 Acquired in-process research and development expenses — — — 78,750 Total operating expenses 150,746 121,298 430,664 472,565 Operating loss ( 26,093 ) ( 31,545 ) ( 98,545 ) ( 198,170 ) Other income (expense), net: Interest income and other, net 5,344 5,656 13,482 17,305 Interest expense ( 1,865 ) ( 4,840 ) ( 5,555 ) ( 8,079 ) Loss on extinguishment of debt — — ( 1,268 ) — Total other income (expense), net 3,479 816 6,659 9,226 Loss before income taxes ( 22,614 ) ( 30,729 ) ( 91,886 ) ( 188,944 ) Income tax expense 637 2,232 4,894 3,665 Net loss $ ( 23,251 ) $ ( 32,961 ) $ ( 96,780 ) $ ( 192,609 ) Other comprehensive income (loss): Unrealized gain on short-term investments $ 3,948 $ 349 $ 2,189 $ 1,800 Foreign currency translation gains (losses) 1,175 ( 1,362 ) 312 ( 2,189 ) Comprehensive loss $ ( 18,128 ) $ ( 33,974 ) $ ( 94,279 ) $ ( 192,998 ) Net loss per share - basic and diluted $ ( 0.35 ) $ ( 0.51 ) $ ( 1.48 ) $ ( 2.97 ) Weighted average shares used to compute basic and diluted net loss per share 65,538 65,117 65,287 64,834 See accompanying notes to unaudited condensed consolidated financial statements. 2 TANDEM DIABETES CARE, INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (Unaudited) (In thousands) Three Months Ended September 30, 2024 Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Income (Loss) Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance at June 30, 2024 65,435 $ 65 $ 1,260,392 $ ( 1,253 ) $ ( 1,025,329 ) $ 233,875 Exercise of stock options 24 — 409 — — 409 Vesting of restricted stock units, net of shares withheld for taxes 187 1 ( 4,928 ) — — ( 4,927 ) Stock-based compensation expense — — 26,481 — — 26,481 Unrealized gain on short-term investments — — — 3,948 — 3,948 Foreign currency translation gains — — — 1,175 — 1,175 Net loss — — — — ( 23,251 ) ( 23,251 ) Balance at September 30, 2024 65,646 $ 66 $ 1,282,354 $ 3,870 $ ( 1,048,580 ) $ 237,710 Nine Months Ended September 30, 2024 Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Income (Loss) Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance at December 31, 2023 65,552 $ 66 $ 1,263,997 $ 1,369 $ ( 951,800 ) $ 313,632 Stock repurchase and retirement of shares ( 1,107 ) ( 1 ) ( 29,999 ) — — ( 30,000 ) Exercise of stock options 94 — 1,806 — — 1,806 Vesting of restricted stock units, net of shares withheld for taxes 705 1 ( 17,125 ) — — ( 17,124 ) Issuance of common stock under Employee Stock Purchase Plan 402 — 6,286 — — 6,286 Stock-based compensation expense — — 73,018 — — 73,018 Purchase of capped call options related to convertible notes due 2029 — — ( 15,813 ) — — ( 15,813 ) Unwind of capped call options related to convertible notes due 2025 — — 184 — — 184 Unrealized gain on short-term investments — — — 2,189 — 2,189 Foreign currency translation gains — — — 312 — 312 Net loss — — — — ( 96,780 ) ( 96,780 ) Balance at September 30, 2024 65,646 $ 66 $ 1,282,354 $ 3,870 $ ( 1,048,580 ) $ 237,710 See accompanying notes to unaudited condensed consolidated financial statements. 3 Three Months Ended September 30, 2023 Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance at June 30, 2023 65,062 $ 65 $ 1,219,199 $ ( 1,193 ) $ ( 888,837 ) $ 329,234 Exercise of stock options 8 — 106 — — 106 Vesting of restricted stock units, net of shares withheld for taxes 121 — ( 1,945 ) — — ( 1,945 ) Issuance of common stock for Employee Stock Purchase Plan — — — — — — Stock-based compensation expense — — 20,579 — — 20,579 Unrealized gain on short-term investments — — — 349 — 349 Foreign currency translation losses — — — ( 1,362 ) — ( 1,362 ) Net loss — — — — ( 32,961 ) ( 32,961 ) Balance at September 30, 2023 65,191 $ 65 $ 1,237,939 $ ( 2,206 ) $ ( 921,798 ) $ 314,000 Nine Months Ended September 30, 2023 Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance at December 31, 2022 64,513 $ 65 $ 1,170,888 $ ( 1,817 ) $ ( 729,189 ) $ 439,947 Exercise of stock options 71 — 1,267 — — 1,267 Vesting of restricted stock units, net of shares withheld for taxes 358 — ( 6,505 ) — — ( 6,505 ) Issuance of common stock under Employee Stock Purchase Plan 249 — 6,804 — — 6,804 Exercise of common stock warrants — — — — — — Stock-based compensation expense — — 65,485 — — 65,485 Unrealized gain on short-term investments — — — 1,800 — 1,800 Foreign currency translation losses — — — ( 2,189 ) — ( 2,189 ) Net loss — — — — ( 192,609 ) ( 192,609 ) Balance at September 30, 2023 65,191 $ 65 $ 1,237,939 $ ( 2,206 ) $ ( 921,798 ) $ 314,000 See accompanying notes to unaudited condensed consolidated financial statements. 4 TANDEM DIABETES CARE, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (In thousands) Nine Months Ended September 30, 2024 2023 Operating Activities Net loss $ ( 96,780 ) $ ( 192,609 ) Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Depreciation and amortization expense 12,362 11,684 Amortization of debt issuance costs 1,587 1,711 Provision for expected credit losses 7,302 4,066 Operating lease termination and other impairment charges 2,000 14,099 Accretion (amortization) of discount or premium on short-term investments ( 595 ) 3,177 Stock-based compensation expense 73,217 65,335 Loss on extinguishment of debt 1,268 — Acquired in-process research and development expenses — 78,750 Other 1,610 ( 1,437 ) Changes in operating assets and liabilities: Accounts receivable, net ( 8,712 ) 9,872 Inventories 5,215 ( 32,714 ) Prepaid and other current assets ( 3,427 ) ( 7,296 ) Other long-term assets 440 ( 1,216 ) Accounts payable and accrued expenses ( 952 ) ( 4,574 ) Employee-related liabilities 15,300 5,571 Deferred revenue ( 3,589 ) 10,042 Operating leases and other current liabilities 6,898 10,745 Other long-term liabilities 364 200 Net cash used in operating activities 13,508 ( 24,594 ) Investing Activities Purchases of short-term investments ( 251,361 ) ( 391,025 ) Proceeds from maturities and redemptions of short-term investments 239,031 415,485 Purchases of property and equipment ( 16,162 ) ( 21,605 ) Acquisitions, including in-process research and development, net of cash acquired — ( 69,496 ) Purchases of intangible assets and strategic investments — ( 2,515 ) Net cash used in investing activities ( 28,492 ) ( 69,156 ) Financing Activities Proceeds from issuance of convertible senior notes due 2029, net of $ 9,400 debt issuance costs 306,850 — Repurchase of $ 246,740 principal amount of convertible senior notes due 2025 ( 246,123 ) — Payment for capped call transactions related to convertible senior notes due 2029 ( 15,813 ) — Repurchase and retirement of common stock ( 30,000 ) Proceeds from issuance of common stock under Company stock plans, net of cash used to settle withholding taxes on vested restricted stock ( 9,032 ) 1,567 Other financing activities 183 ( 71 ) Net cash provided by (used in) financing activities 6,065 1,496 Effect of foreign exchange rate changes on cash ( 910 ) ( 652 ) Net increase (decrease) in cash and cash equivalents ( 9,829 ) ( 92,906 ) Cash and cash equivalents at beginning of period 58,868 172,517 Cash and cash equivalents at end of period $ 49,039 $ 79,611 Supplemental disclosures of cash flow information Income taxes paid $ 1,298 $ 1,771 Supplemental schedule of non-cash investing and financing activities Operating lease right-of-use assets obtained in exchange for operating lease obligations $ 4,659 $ — Purchases of property and equipment included in accounts payable $ 2,641 $ 3,224 See accompanying notes to unaudited condensed consolidated financial statements. 5 TANDEM DIABETES CARE, INC. NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 1. Organization and Basis of Presentation The Company Tandem Diabetes Care, Inc. is a medical device company focused on the design, development and commercialization of technology solutions for people living with diabetes. Tandem Diabetes Care, Inc. is incorporated in the state of Delaware. Unless the context requires otherwise, the terms the “Company” or “Tandem” refer to Tandem Diabetes Care, Inc., together with its wholly-owned subsidiaries. The Company manufactures, sells, and supports insulin pump products that are designed to address the evolving needs and preferences of differentiated segments of the insulin-dependent diabetes market. The Company recently expanded its insulin pump portfolio, which now includes both the t:slim X2 and the Tandem Mobi. Both pumps feature Control-IQ technology, which is the Company’s advanced algorithm for managing insulin delivery, using information received from integrated continuous glucose monitoring (CGM) sensors. New software for the insulin pumps may be updated remotely by the individual users as new advancements become available and are compatible with other complementary digital health offerings, such as the mobile application and cloud-based diabetes management applications. The Company’s insulin pump systems products are generally considered durable medical equipment and have an expected lifespan of at least four years . In addition to insulin pumps, the Company sells single-use components that are used together with the pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body. Basis of Presentation and Principles of Consolidation The Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments which are of a normal and recurring nature and considered necessary for a fair presentation of the financial information contained herein, have been included. Interim financial results are not necessarily indicative of results anticipated for the full year or any other period(s). These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (Annual Report), from which the consolidated balance sheet presented as of December 31, 2023 herein was derived. The condensed consolidated financial statements include the accounts of Tandem Diabetes Care, Inc. and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. The functional currency of the Company’s foreign subsidiaries is their respective local currency. The Company translates the financial statements of its foreign subsidiaries into U.S. dollars using period-end exchange rates for assets and liabilities and average exchange rates for each period for revenue, costs and expenses. Translation related adjustments are included in other comprehensive income (loss) in the condensed consolidated statements of operations, and in accumulated other comprehensive income (loss) in the stockholders’ equity section of the Company’s condensed consolidated balance sheets. Foreign exchange gains or losses resulting from balances denominated in a currency other than the functional currency are recognized in interest income and other, net in the Company’s condensed consolidated statements of operations. 2. Summary of Significant Accounting Policies There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2024, as compared to those disclosed in the Annual Report. 6 Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes as of the date of the condensed consolidated financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Accounts Receivable The Company grants credit to various customers in the ordinary course of business and is paid directly by customers who use its products, distributors and third-party insurance payors. The Company maintains an allowance for its current estimate of expected credit losses. Provisions for expected credit losses are estimated based on historical experience, assessment of specific customer-related risks, review of outstanding invoices, forecasts about the future, and various other assumptions and estimates that are believed to be reasonable under the circumstances, including changes to credit risks as a result of recessionary concerns, changes in discretionary spending, increased interest rates, and other macroeconomic factors. Uncollectible accounts are written off against the allowance after appropriate collection efforts have been exhausted and when it is deemed that a balance is uncollectible. Operating Lease Right-of-Use Assets and Liabilities Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized when the Company takes possession of the leased property (Commencement Date) based on the present value of lease payments over the lease term. For lease agreements that contain lease and non-lease components, the Company accounts for both of those components as a single lease component. Rent expense on noncancelable leases containing known future scheduled rent increases is recorded on a straight-line basis over the term of the respective leases beginning on the Commencement Date. The difference between rent expense and rent paid is accounted for as a component of operating lease right-of-use assets on the Company’s condensed consolidated balance sheets. Landlord improvement allowances and other similar lease incentives are recorded as a reduction of the right-of-use leased assets, and are amortized on a straight-line basis as a reduction to operating lease costs. Intangible Assets Subject to Amortization Finite-lived intangible assets are recorded at cost, net of accumulated amortization and, if applicable, impairment charges. Amortization of finite-lived intangible assets is recognized over their estimated useful lives on a straight-line basis. The Company did not recognize any intangible asset impairment losses during the three and nine months ended September 30, 2024 and 2023. Strategic Investments The Company held equity investments totaling $ 30.4 million and $ 10.1 million in private companies at September 30, 2024 and December 31, 2023, respectively. The investments were included as a component of other long-term assets on the condensed consolidated balance sheets at September 30, 2024 and December 31, 2023. The investments were carried at cost minus impairment, if any, adjusted for changes in observable prices. The Company monitors these investments to evaluate whether any increase or decline in its value has occurred, based on the implied value of recent company financings, public market prices of comparable companies and general market conditions. In November 2024, the Company signed an investment agreement with one of its private company investees. Per the agreement, the Company will invest an additional $ 46.4 million. The investment is expected to close in the fourth quarter of 2024, and represent a cumulative investment of more than 20 % of the private company’s outstanding equity. The investment will be recorded using the equity method and will be included in long-term assets on the Company’s consolidated balance sheet. The Company did no t record any impairment charges related to its strategic investments in the three months ended September 30, 2024. During the nine months ended September 30, 2024, the Company recorded an impairment charge of $ 2.0 million related to one of its investments in a private company. The Company did no t record any impairment charges related to its strategic investments in the three and nine months ended September 30, 2023. 7 Approximately $ 22.2 million of the total strategic investments balance was previously held in the form of subordinated convertible notes of one private investee company. The subordinated notes were converted into equity of the private company at final maturity, which occurred in June 2024. As a result of the note conversion, the Company received shares of the private investee company. As of September 30, 2024, and December 31, 2023, each of the Company’s equity investments in private companies represented less than 15 % of the outstanding equity of the respective private company. Revenue Recognition Revenue is generated primarily from sales of insulin pumps, single-use insulin cartridges and infusion sets to individual customers with third-party insurance coverage and through a network of distributors that resell the products to insulin-dependent diabetes customers. The Company recognizes revenue when it transfers control of the promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services, net of estimated rebates and returns. Revenue Recognition for Arrangements with Multiple Performance Obligations The Company considers the individual deliverables in its product offerings to be separate performance obligations. The transaction price is determined based on the consideration expected to be received, based either on the stated value in contractual arrangements or the estimated cash to be collected in non-contracted arrangements. The Company allocates the consideration to the individual performance obligations and recognizes the consideration based on when the performance obligation is satisfied, considering whether or not this occurs at a point in time or over time. Generally, insulin pumps, cartridges, infusion sets, and accessories are deemed performance obligations that are satisfied at a point in time when the customer obtains control of the promised good, which typically is upon shipment for our distributor arrangements and upon receipt for sales directly to individual customers. Complementary products, such as the Company’s data management and software update platforms, are considered distinct performance obligations that are satisfied over time, as access and support for these products is provided throughout the typical four-year warranty period of the insulin pumps. Accordingly, revenue related to the complementary products is deferred and recognized over a four-year period. Where there is no standalone value for the complementary product, the Company determines its value by applying the expected cost plus a margin approach and then allocates the residual to the insulin pumps. Revenue Recognition for Tandem Choice Program In September 2022, the Company launched a new technology access program referred to as Tandem Choice, that provides eligible, in-warranty t:slim X2 customers in the United States with the flexibility to obtain the newest hardware platform, Tandem Mobi, when commercially available. Participating customers have the right to purchase the alternative Tandem pump for a fee, referred to as a choice right. The program was determined to create a material right for which a portion of each t:slim X2 pump transaction price was allocated and deferred. The Company determined that the ability for a customer to upgrade to a new technology represents a material right because the pricing inherent in such option provides the customer with a discount that is incremental to the range of discounts that would otherwise be granted for the related goods and services to comparable customers. The standalone selling price for the choice right was estimated based on the adjusted market assessment approach and contemplated the likelihood that the respective option will be exercised. The Company began selling Tandem Mobi insulin pumps in the first quarter of 2024 and eligibility for the Tandem Choice program ended in February 2024. Consequently, the Company ceased to allocate and defer a portion of the transaction price for the material right for pumps sold after that date. Eligible customers who purchased a t:slim X2 insulin pump during the program period will have until December 31, 2024 to exercise the option to switch to the Tandem Mobi for a stated fee. The Company will recognize the deferred sales when the obligations under the Tandem Choice program are satisfied. If a customer elects to participate in the program, the Company will recognize upgrade fees received, and the associated cost of goods sold at the time of fulfilling the obligation. Any remaining deferrals will be recognized at program expiration on December 31, 2024, provided all obligations under the Tandem Choice program are satisfied. For the nine months ended September 30, 2024, the net effect of Tandem Choice deferrals and fulfillments was negligible. At September 30, 2024 and December 31, 2023, current deferred revenue balance was $ 30.1 million and $ 30.6 million, respectively, related to the Tandem Choice program. 8 Sales Rebates The Company is subject to certain rebates on pricing programs with managed care organizations, such as governmental and third-party commercial payors. The Company estimates provisions for rebates based on contractual arrangements, estimates of products sold subject to rebate, known events or trends and channel inventory data. Estimated sales rebates included in other long-term liabilities have an estimated payment due date beyond twelve months from the balance sheet date. Accordingly, actual rebates paid may differ from estimated amounts recorded in the accompanying condensed consolidated financial statements. As of September 30, 2024 and December 31, 2023, total estimated sales rebates were included in the following condensed consolidated balance sheet accounts (in thousands): September 30, 2024 December 31, 2023 Other current liabilities $ 3,012 $ 505 Other long-term liabilities 6,503 8,042 Total sales rebate $ 9,515 $ 8,547 Warranty Reserve The Company generally provides a four-year warranty on its insulin pumps to end-user customers and may replace any pumps that do not function as intended in accordance with the product specifications within the warranty period. Additionally, the Company offers a six-month warranty on single-use insulin cartridges and infusion sets. Estimated warranty costs are recorded at the time of shipment, and the Company reevaluates the estimate of the warranty reserve obligation at each reporting period. Warranty costs are estimated primarily based on the current expected product replacement cost and expected replacement rates using historical experience. Insulin pumps returned to the Company may be refurbished and redeployed. Experience has shown that initial data for any given pump version or pump platform may be insufficient. Therefore, the Company’s process relies on long-term historical averages of existing platforms until sufficient data are available. As actual experience becomes available, the Company uses the data to update the historical averages. The Company may make further adjustments to the warranty reserve when deemed appropriate, giving additional consideration to revised future expectations of performance based on enhanced hardware components, or new features and capabilities that may become available through Tandem Device Updater. Warranty expense is recorded as a component of cost of sales in the condensed consolidated statements of operations. The following table provides a reconciliation of the changes in product warranty liabilities for the three and nine months ended September 30, 2024 and 2023 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Balance at beginning of the period $ 37,356 $ 38,917 $ 37,173 $ 36,537 Provision for warranties issued during the period 11,084 9,601 31,074 26,889 Settlements made during the period ( 9,576 ) ( 8,986 ) ( 27,675 ) ( 24,054 ) Increases (decreases) in warranty estimates 1,882 ( 1,775 ) 174 ( 1,615 ) Balance at end of the period $ 40,746 $ 37,757 $ 40,746 $ 37,757 As of September 30, 2024 and December 31, 2023, total product warranty reserves were included in the following condensed consolidated balance sheet accounts (in thousands): September 30, 2024 December 31, 2023 Other current liabilities $ 19,832 $ 18,135 Other long-term liabilities 20,914 19,038 Total warranty reserve $ 40,746 $ 37,173 9 Stock-Based Compensation Stock-based compensation cost is measured at the grant date based on the estimated fair value of the award, and the portion that is ultimately expected to vest is recognized as compensation expense over the requisite service period on a straight-line basis. The Company estimates the fair value of stock options issued under the Company’s stock incentive plans, and the fair value of the employees’ purchase rights under the Company’s Employee Stock Purchase Plan (ESPP) using the Black-Scholes option pricing model on the date of grant. The Black-Scholes option pricing model requires the use of assumptions about a number of variables, including stock price volatility, expected term, dividend yield and risk-free interest rate (see Note 8, “Stockholders’ Equity”). The fair value of restricted stock unit (RSU) awards issued under the Company’s stock incentive plans that vest solely based on service, is estimated based on the fair market value of the underlying stock on the date of grant. The fair value of RSU awards that vest based upon the Company’s actual performance relative to predefined performance metrics and the awardee’s continuing service through the measurement date is generally estimated based on the fair market value of the underlying stock on the date of grant and the probability that the specified performance criteria will be met. At each reporting period, the Company reassesses the probability of the achievement of such performance metrics. Any expense change resulting from an adjustment in the estimated shares to be released is recorded in the period of adjustment. Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing the net income or loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net income (loss) per share reflects the potential dilution that would occur if securities exercisable for or convertible into common stock were exercised for or converted into common stock. Dilutive common share equivalents are comprised of stock options and unvested RSUs outstanding under the Company’s stock incentive plans, potential awards to be granted pursuant to the ESPP, and common stock warrants, each calculated using the treasury stock method, and shares issuable upon conversion of the convertible senior notes calculated using the if-converted method. For the three and nine months ended September 30, 2024 and 2023, there was no difference in the weighted average number of shares used to calculate basic and diluted net loss per share due to the Company’s net loss position for each of the periods presented. Potentially dilutive securities outstanding and not included in the calculation of diluted net loss per share (because inclusion would be anti-dilutive) are as follows (in thousands, in common stock equivalent shares): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Options to purchase common stock 781 135 125 135 Unvested restricted stock units 3,964 2,930 2,995 2,011 Warrants to purchase common stock 194 194 194 194 Awards granted under the ESPP 292 173 147 80 Convertible senior notes (if-converted) 9,513 2,554 7,762 2,554 14,744 5,986 11,223 4,974 Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU 2023-07 to improve the information that a public entity discloses about reportable segments and to address investor requests for more information about reportable segment expenses. The pronouncement requires a public entity to report a measure of segment profit or loss that the chief operating decision maker (CODM) uses to assess segment performance and make decisions about allocating resources. ASU 2023-07 also requires other specified segment items and amounts, such as depreciation, amortization, and depletion expense, to be disclosed under certain circumstances. The amendments in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, adopted retrospectively. The Company is currently evaluating the effect of adoption of ASU 2023-07 on the Company’s consolidated financial statements or disclosures. 10 3. Short-Term Investments The Company invests in marketable securities primarily consisting of debt instruments of the United States Government, United States Government-sponsored enterprises, and financial institutions and corporations with strong credit ratings. The following represents a summary of the estimated fair value of short-term investments at September 30, 2024 and December 31, 2023 (in thousands): At September 30, 2024 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Estimated Fair Value Available-for-sale securities: United States Government-sponsored enterprises $ 166,401 $ 1,718 $ ( 9 ) $ 168,110 United States Treasury securities 112,169 448 ( 8 ) 112,609 Commercial paper 23,431 82 — 23,513 Corporate debt securities 116,314 653 ( 1 ) 116,966 Foreign government bonds 3,013 55 — 3,068 Total $ 421,328 $ 2,956 $ ( 18 ) $ 424,266 At December 31, 2023 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Estimated Fair Value Available-for-sale securities: United States Government-sponsored enterprises $ 181,851 $ 518 $ ( 215 ) $ 182,154 United States Treasury securities 114,714 318 ( 28 ) 115,004 Commercial paper 72,505 33 ( 27 ) 72,511 Corporate debt securities 39,225 156 ( 6 ) 39,375 Total $ 408,295 $ 1,025 $ ( 276 ) $ 409,044 The contractual maturities of available-for-sale debt securities as of September 30, 2024, were as follows (in thousands): Years to Maturity At September 30, 2024 Within One Year One to Two Years Two to Three Years Estimated Fair Value United States Government-sponsored enterprises $ 60,575 $ 24,215 $ 83,320 $ 168,110 United States Treasury securities 71,407 40,194 1,008 112,609 Commercial paper 23,513 — — 23,513 Corporate debt securities 62,532 54,434 — 116,966 Foreign government bonds — — 3,068 3,068 Total $ 218,027 $ 118,843 $ 87,396 $ 424,266 The Company has classified all marketable securities, regardless of maturity, as short-term investments based upon the Company’s ability and intent to use any of those marketable securities to satisfy the Company’s liquidity requirements. The Company reviews the portfolio of available-for-sale debt securities quarterly to determine if any investment is impaired due to changes in credit risk or other potential valuation concerns. Unrealized losses on available-for-sale debt securities at September 30, 2024 were primarily due to an increase in market interest rates after certain debt securities were purchased, and the balance was not material to the Company’s quarterly results. 4. Composition of Certain Financial Statement Items 11 Accounts Receivable Accounts receivable, net consisted of the following at September 30, 2024 and December 31, 2023 (in thousands): September 30, December 31, 2024 2023 Accounts receivable $ 113,249 $ 110,453 Less: allowance for credit losses ( 6,061 ) ( 4,898 ) Accounts receivable, net $ 107,188 $ 105,555 Allowance for Credit Losses The following table provides a reconciliation of the changes in the allowance for estimated accounts receivable credit losses for the three and nine months ended September 30, 2024 and 2023 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Balance at beginning of the period $ 5,225 $ 4,842 $ 4,898 $ 4,327 Provision for expected credit losses 3,579 1,308 7,302 4,066 Write-offs and adjustments, net of recoveries ( 2,743 ) ( 795 ) ( 6,139 ) ( 3,038 ) Balance at end of the period $ 6,061 $ 5,355 $ 6,061 $ 5,355 Inventories Inventories consisted of the following at September 30, 2024 and December 31, 2023 (in thousands): September 30, December 31, 2024 2023 Raw materials $ 35,933 $ 42,783 Work-in-process 35,829 44,026 Finished goods 80,679 71,128 Total inventories $ 152,441 $ 157,937 5. Fair Value Measurements The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2024 and December 31, 2023, and indicates the fair value hierarchy of the valuation techniques used by the Company to determine such fair value (in thousands): 12 Fair Value Measurements at September 30, 2024 Total Level 1 Level 2 Level 3 Assets Cash equivalents (1) $ 38,830 $ 38,830 $ — $ — United States Government-sponsored enterprises 168,110 — 168,110 — United States Treasury securities 112,609 112,609 — — Commercial paper 23,513 — 23,513 — Corporate debt securities 116,966 — 116,966 — Foreign government bonds 3,068 — 3,068 — Total assets $ 463,096 $ 151,439 $ 311,657 $ — Fair Value Measurements at December 31, 2023 Total Level 1 Level 2 Level 3 Assets Cash equivalents (1) $ 48,033 $ 48,033 $ — $ — United States Government-sponsored enterprises 182,154 — 182,154 — United States Treasury securities 115,004 115,004 — — Commercial paper 72,511 — 72,511 — Corporate debt securities 39,375 — 39,375 — Total assets $ 457,077 $ 163,037 $ 294,040 $ — (1) Generally, cash equivalents include money market funds and investments with a maturity of three months or less from the date of purchase. The Company’s Level 1 financial instruments, which are in active markets, are valued using unadjusted quoted market prices for identical instruments. The Company’s Level 2 financial instruments are valued using market prices on less active markets with observable valuation inputs such as interest rates and yield curves. The Company obtains the fair value of Level 2 financial instruments from quoted market prices, calculated prices or quotes from third-party pricing services. The Company validates these prices through independent valuation testing and review of portfolio valuations provided by the Company’s investment managers. There were no transfers into or out of Level 3 assets during the three months ended September 30, 2024 and 2023, respectively. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued expenses, and employee-related liabilities are reasonable estimates of their fair values because of the short-term nature of these assets and liabilities. Short-term investments are carried at fair value. The Company’s convertible senior notes are carried at amortized cost on the condensed consolidated balance sheets (see Note 7, “Debt”). The Company estimated the fair value of its convertible senior notes based on Level 2 quoted market prices as follows (in thousands): 13 Fair Value Measurements at September 30, 2024 December 31, 2023 Convertible Senior Notes due 2025 $ 39,130 $ 271,688 Convertible Senior Notes due 2029 458,043 * Total fair value of outstanding convertible senior notes $ 497,173 $ 271,688 * Not applicable as no notes were outstanding at this date. In March 2024, the Company issued $ 316.3 million aggregate principal amount of the Company’s Convertible Senior Notes Due 2029, and repurchased $ 246.7 million of principal of the Company’s Convertible Senior Notes due 2025 (see Note 7, “Debt”). 6. Leases The Company's leases consist of operating leases for general office space, research and development, manufacturing and warehouse facilities, and equipment. These noncancellable operating leases have initial lease terms from two years to thirteen years . Certain leases include an option to renew, with renewal terms that can extend the lease term for additional periods at the Company’s sole discretion. The Company includes the renewal option period in the lease term for those leases reasonably expected to be extended at the time of lease commencement. Operating Lease Impairment Charge In 2023, the Company consolidated facilities by moving the administrative functions and other operations from the leased space on Vista Sorrento Parkway in San Diego, California (Vista Sorrento Lease) to the Company’s new headquarters, located on High Bluff Drive in San Diego, California. In connection with permanently ceasing use of the Vista Sorrento Lease, the Company recorded a $ 14.1 million impairment charge as the carrying amount of the assets related to the Vista Sorrento Lease exceeded its fair value based on the Company’s estimate of future discounted cash flows related to the leased facility. The $ 14.1 million charge was comprised of an $ 11.2 million impairment of operating lease right-of-use assets and a $ 2.9 million write-off of fixed assets, and was recorded as a component of selling, general and administrative expenses in the condensed consolidated statements of operations. Supplemental Lease Disclosure Information The Company’s lease costs recorded in the condensed consolidated statements of operations were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating lease cost $ 3,603 $ 3,528 $ 10,684 $ 12,457 Short-term lease cost 22 22 65 87 Loss on lease termination and right-of-use asset impairment charges — — — 11,224 Total lease cost $ 3,625 $ 3,550 $ 10,749 $ 23,768 14 Maturities of operating lease liabilities at September 30, 2024 were as follows (in thousands): Years Ending December 31, 2024 $ 4,433 2025 18,188 2026 18,146 2027 18,449 2028 14,934 Thereafter 90,326 Total undiscounted lease payments 164,476 Less: amount representing interest ( 36,964 ) Present value of operating lease liabilities 127,512 Less: current portion of operating lease liabilities ( 18,033 ) Operating lease liabilities - long-term $ 109,479 The weighted-average remaining lease term and weighted-average discount rate for operating leases were as follows: September 30, 2024 December 31, 2023 Weighted-average remaining lease term (in years) 9.4 10.2 Weighted-average discount rate used to determine operating lease liabilities 5.3 % 5.4 % Cash amounts paid included in the measurement of lease liabilities, representing operating cash flows, were $ 13.3 million and $ 9.2 million for the nine months ended September 30, 2024 and 2023, respectively. 7. Debt Convertible Senior Notes Due 2029 On March 8, 2024, the Company completed an offering of $ 316.3 million aggregate principal amount of 1.50 % Convertible Senior Notes due 2029 (the 2029 Notes). The proceeds from the issuance of the 2029 Notes were $ 306.8 million, net of debt issuance costs. The Company used approximately $ 246.1 million of the net proceeds to repurchase approximately $ 246.7 million in aggregate principal amount of its Convertible Senior Notes Due 2025 (the 2025 Notes) concurrently with the pricing of the 2029 Notes in privately negotiated transactions. The Company also paid $ 1.3 million of accrued interest due at time of the note repurchase. As a result of the repurchase, the Company recognized a $ 1.3 million loss on extinguishment of debt in the condensed consolidated statement of operations for the nine months ended September 30, 2024. The loss on extinguishment of debt included the unamortized debt issuance costs related to the portion of the 2025 Notes repurchased. The Company used $ 30.0 million of the net proceeds to repurchase shares of the Company’s common stock from certain purchasers of the 2029 Notes at a purchase price equal to the last reported sale price per share of the Company’s common stock on March 5, 2024, which was $ 27.105 per share. In addition, the Company used $ 15.8 million of the net proceeds to pay the cost of the capped call transactions (2029 Capped Call Transactions) discussed below. The 2029 Notes are the Company’s senior unsecured obligations. Interest is payable in cash semi-annually in arrears on March 15 and September 15 of each year beginning on September 15, 2024, at a rate of 1.50 % per year. The 2029 Notes mature on March 15, 2029 unless repurchased, redeemed, or converted in accordance with their terms prior to the maturity date. The initial conversion rate for the 2029 Notes is 28.9361 shares of common stock per $1,000 principal amount of the 2029 Notes, which is equivalent to an initial conversion price of approximately $ 34.56 per share of the Company’s common stock (2029 Notes Conversion Price). The conversion rate is subject to customary adjustments for certain events as described in the indenture governing the 2029 Notes. 15 The Company may not redeem the 2029 Notes before March 22, 2027. The Company has the option to redeem for cash all or any portion of the 2029 Notes on or after March 22, 2027 if the last reported sale price of the Company’s common stock has been at least 130 % of the 2029 Notes Conversion Price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period, at a redemption price equal to 100 % of the principal amount of the 2029 Notes to be redeemed, plus accrued and unpaid interest. No sinking fund is provided for the 2029 Notes. Holders of the 2029 Notes may convert all or a portion of their 2029 Notes at their option before December 15, 2028, in multiples of $1,000 principal amounts, only under the following circumstances: • during any calendar quarter commencing after the quarter ending on June 30, 2024 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock, 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 2029 Notes Conversion Price on each applicable trading day; • during the five business day period after any ten consecutive trading day period (the measurement period) in which the trading price per $1,000 principal amount of the 2029 Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of the Company’s common stock and the applicable conversion rate of the 2029 Notes on such trading day; • if the Company calls such 2029 Notes for redemption, at any time before the close of business on the scheduled trading day immediately preceding the redemption date, but only with respect to the 2029 Notes called (or deemed called) for redemption; or • on the occurrence of specified corporate events. On or after December 15, 2028, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their 2029 Notes, in integral multiples of $1,000 principal amount, 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 governing the 2029 Notes. Convertible Senior Notes Due 2025 In May 2020, the Company completed an offering of $ 287.5 million aggregate principal amount of 1.50 % Convertible Senior Notes due 2025 (the 2025 Notes). The proceeds from the issuance of the Notes were $ 244.6 million, net of debt issuance costs and cash used to pay the cost of the capped call transactions (Capped Call Transactions) discussed below. In March 2024, the Company repurchased for cash $ 246.7 million in aggregate principal amount of the 2025 Notes, concurrently with the pricing of the 2029 Notes in privately negotiated transactions. The 2025 Notes are the Company’s senior unsecured obligations. Interest is payable in cash semi-annually in arrears beginning on November 1, 2020 at a rate of 1.50 % per year. The 2025 Notes mature on May 1, 2025 unless repurchased, redeemed, or converted in accordance with their terms before the maturity date. As of September 30, 2024 the outstanding balance of the 2025 Notes was classified in current liabilities on the Company’s condensed consolidated balance sheets. The 2025 Notes are convertible into cash, shares of the Company’s common stock, or a combination of cash and shares of the Company’s common stock, at the Company’s election, at an initial conversion rate of 8.8836 shares of common stock per $1,000 principal amount of the 2025 Notes, which is equivalent to an initial conversion price of $ 112.57 (2025 Notes Conversion Price) per share of the Company’s common stock. The conversion rate is subject to customary adjustments for certain events as described in the indenture governing the 2025 Notes. The Company has the option to redeem for cash all or any portion of the 2025 Notes on or after May 6, 2023 if the last reported sale price of the Company’s common stock has been at least 130 % of the 2025 Notes Conversion Price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period, at a redemption price equal to 100 % of the principal amount of the 2025 Notes to be redeemed, plus accrued and unpaid interest. No sinking fund is provided for the 2025 Notes. 16 Holders of the 2025 Notes had the right to convert all or a portion of their 2025 Notes at their option before November 1, 2024, in multiples of $1,000 principal amounts, under certain circumstances outlined in the offering agreement. On or after November 1, 2024, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert 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 governing the 2025 Notes. Holders of the 2025 Notes who convert in connection with a make-whole fundamental change or in connection with a redemption are entitled to an increase in the conversion rate. Additionally, in the event of a fundamental change, holders of the 2025 Notes may require us to repurchase all or a portion of the 2025 Notes at a price equal to 100 % of the principal amount of the Notes, plus any accrued and unpaid interest. The net carrying amount of the Company’s convertible senior notes on the condensed consolidated balance sheets consisted of the following (in thousands): September 30, 2024 December 31, 2023 Principal amount: Convertible Senior Notes Due 2025 $ 40,760 $ 287,500 Convertible Senior Notes Due 2029 316,250 * Total principal amount 357,010 287,500 Unamortized debt issuance costs ( 8,576 ) ( 2,465 ) Total debt, net $ 348,434 $ 285,035 Less: current portion ( 40,605 ) — Long-term senior convertible notes $ 307,829 $ 285,035 * Not applicable as no notes were outstanding at this date. As of September 30, 2024 and December 31, 2023, the if-converted value of the 2025 Notes did not exceed the principal amount. As of September 30, 2024, the if-converted value of the 2029 Notes exceeded the principal amount by $ 71.8 million. In October 2023, the Company was notified that additional interest beyond the 1.50 % per annum had been accruing on the 2025 Notes since May 2021, under the terms of the indenture. This additional interest accrued at a rate of 0.50 % per annum on the outstanding principal amount of the Notes, and as of September 30, 2023 amounted to about $ 3.1 million in the aggregate. The additional accrued interest was fully paid in November 2023. The following table summarizes the effective interest rates for each of our convertible senior notes for the periods shown: Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Effective interest rate: Convertible Senior Notes Due 2025 2.1 % 2.2 % 2.1 % 2.2 % Convertible Senior Notes Due 2029 2.1 % * 2.1 % * * Not applicable as no notes were outstanding at this date. 17 The following table details interest expense related to the Notes recognized for the three and nine months ended September 30, 2024, and 2023 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Contractual interest expense (1) $ 1,339 $ 4,138 $ 3,823 $ 6,368 Amortization of debt issuance costs 502 702 1,404 1,711 Total interest expense $ 1,841 $ 4,840 $ 5,227 $ 8,079 (1) Contractual interest expense for the three and nine months ended September 30, 2023 includes $ 3.1 million of additional interest as discussed above. 2029 Capped Call Transactions In connection with the issuance of the 2029 Notes, the Company entered into Capped Call Transactions in March 2024 with certain counterparties at a net cost of $ 15.8 million (2029 Capped Call Transactions). The 2029 Capped Call Transactions are expected generally to reduce potential dilution to the Common Stock upon any conversion of the 2029 Notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted 2029 Notes, as the case may be, with such reduction and/or offset subject to a cap based on a cap price initially equal to $ 42.0128 per share, and is subject to certain adjustments under the terms of the 2029 Capped Call Transactions. 2025 Capped Call Transactions In connection with the issuance of the 2025 Notes, the Company entered into Capped Call Transactions in May 2020 with certain counterparties at a net cost of $ 34.1 million (2025 Capped Call Transactions). The 2025 Capped Call Transactions are expected generally to reduce potential dilution to the Common Stock upon any conversion of the 2025 Notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted 2025 Notes, as the case may be, with such reduction or offset subject to a cap. The cap price of the 2025 Capped Call Transactions is initially $ 173.18 per share of the Company’s common stock, and is subject to certain adjustments under the terms of the 2025 Capped Call Transactions. In connection with the repurchase of certain 2025 Notes, the Company entered into unwind agreements with the existing option counterparties on March 5, 2024 to terminate a portion of the existing 2025 Capped Call Transactions in a notional amount corresponding to the amount of 2025 Notes repurchased (the Unwind Transactions). In connection with the Unwind Transactions, the Company received $ 0.2 million in cash as a termination payment in respect of the portion of the existing 2025 Capped Call Transactions that were unwound. The amount received was based generally on the termination values of the unwound portions of the existing 2025 Capped Call Transactions. For accounting purposes, each of the capped call transactions described above are separate transactions, and not part of the terms of the 2029 Notes or the 2025 Notes. As these transactions met certain criteria under the applicable accounting guidance, each of the capped call transactions were recorded in stockholders' equity and were not accounted for as derivatives. The cost of the transactions was recorded as a reduction of the Company’s additional paid-in capital in the Company’s condensed consolidated balance sheet and will not be remeasured. 8. Stockholders’ Equity 18 Shares Reserved for Future Issuance The following shares of the Company's common stock were reserved for future issuance at September 30, 2024 (in thousands): Shares reserved for issuance upon conversion of Convertible Senior Notes 9,513 Shares underlying outstanding warrants 194 Shares underlying outstanding stock options 3,583 Shares underlying unvested restricted stock units 4,020 Shares authorized for issuance pursuant to awards granted under the ESPP 3,052 Shares authorized for future equity award grants 1,879 Total 22,241 Common Stock Warrants Warrants outstanding to purchase shares of the Company's common stock as of September 30, 2024 were as follows: Issue Date Exercise Price Per Share Warrants Outstanding Expiration Date of Warrants Outstanding March 2017 $ 23.50 193,788 March 2027 Each warrant allows the holder to purchase one share of common stock at the per share exercise price of the warrant. Stock Incentive Plans In May 2023, the Company’s stockholders approved the 2023 Long-Term Incentive Plan (2023 Plan), under which 2,602,184 shares of common stock were initially reserved for issuance. Under the 2023 Plan, the Company may grant stock options, stock appreciation rights, restricted stock and restricted stock units to individuals who are then employees, officers, directors or consultants of the Company. The 2023 Plan replaced the Company’s Amended and Restated 2013 Stock Incentive Plan (2013 Plan), and no further equity awards will be granted under the 2013 Plan. In May 2024, the Company’s stockholders approved the 2023 Long-Term Incentive Plan, as amended, to increase the number of shares authorized for issuance under the plan by 3,000,000 shares. Stock-Based Compensation The following table summarizes the allocation of stock-based compensation expense included in the condensed consolidated statements of operations for all stock-based compensation arrangements (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Cost of sales $ 1,675 $ 1,812 $ 5,506 $ 5,154 Selling, general and administrative 16,395 12,466 45,200 41,448 Research and development 8,211 6,463 22,511 18,733 Total stock-based compensation expense $ 26,281 $ 20,741 $ 73,217 $ 65,335 The total stock-based compensation expense capitalized as part of the cost of the Company’s inventories was $ 1.8 million at September 30, 2024, and $ 2.0 million at December 31, 2023. Restricted Stock Units Restricted stock units (RSUs) have a grant value equal to the closing price of the Company’s common stock on the award date. 19 The total number of RSUs granted and the respective weighted average grant date fair value were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 RSUs granted 140,806 208,082 2,193,104 1,997,907 Weighted average grant date fair value (per share) $ 45.66 $ 29.19 $ 45.29 $ 28.94 Employee Stock Purchase Plan In May 2024, the Company's stockholders approved the 2013 Employee Stock Purchase Plan, as amended, to increase the number of shares authorized for issuance under the plan by 3,000,000 shares. The Company records stock-based compensation expense associated with the ESPP using the Black-Scholes option pricing model. Valuations are performed on the grant date at the beginning of the purchase period, which generally occurs in May and November of each year. The assumptions used in the Black-Scholes option pricing model for the ESPP were as follows: Nine Months Ended September 30, 2024 2023 Weighted average grant date fair value (per share) $ 21.45 $ 12.52 Risk-free interest rate 5.1 % 4.7 % Dividend yield 0.0 % 0.0 % Expected volatility 70.2 % 60.9 % Expected term (in years) 1.3 1.3 9. Employee Benefits Employee 401(k) Plan The Company has a defined contribution 401(k) plan for employees in the United States who are at least 18 years of age. Employees are eligible to participate in the plan beginning on the first day of the calendar month following their date of hire. Unless they affirmatively elect otherwise, employees are automatically enrolled in the plan following 30 days from date of hire or entry date. Under the terms of the plan, employees may make voluntary contributions as a percent of compensation and the Company may elect to match a discretionary percentage of employee contributions . 10. Income Taxes For the three and nine months ended September 30, 2024, the Company recognized income tax expense of $ 0.6 million and $ 4.9 million, respectively, on a pre-tax loss of $ 22.6 million and $ 91.9 million, respectively. The Company calculated the provision for income taxes for the three and nine months ended September 30, 2024 by applying an estimate of the annual effective tax rate for the full year to ordinary income (loss) adjusted by the tax impact of discrete items. Income tax expense for the three and nine months ended September 30, 2024 was primarily attributable to federal, state and foreign income tax expense as a result of current taxable income in certain jurisdictions. For the three and nine months ended September 30, 2023, the Company recognized income tax expense of $ 2.2 million and $ 3.7 million, respectively, on a pre-tax loss of $ 30.7 million and $ 188.9 million, respectively. Income tax expense for the three and nine months ended September 30, 2023 was primarily attributable to federal, state and foreign income tax expense as a result of current taxable income in certain jurisdictions. The Company calculated the provision for three and nine months ended September 30, 2023 by applying an estimate of the annual effective tax rate for the full year to ordinary income (loss) adjusted by the tax impact of discrete items. The Company continues to maintain a full valuation allowance against its net deferred tax assets as of September 30, 2024, based on the current assessment that it is not more likely than not these future benefits will be realized before expiration. 20 11. Business Segment and Geographic Information Segment Reporting Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker (CODM) in making decisions regarding resource allocation and assessing performance. The Company is organized based on its current product portfolio, which consists primarily of insulin pumps, single-use insulin cartridges and infusion sets for the storage and delivery of insulin. The Company views its operations and manages its business as one segment and a single reporting unit because key operating decisions and resource allocations are made by the CODM using consolidated financial data. Disaggregation of Revenue The Company primarily sells its products through national and regional distributors in the United States on a non-exclusive basis, and through distribution partners outside the United States. In the United States and Canada, the Company also uses a direct sales force. The Company disaggregates its revenue by geography, major sales channel and product as management believes these categories best depict how the nature, amount and timing of revenues and cash flows are affected by economic factors. Revenues by Geographic Region and Customer Sales Channel During the three and nine months ended September 30, 2024 and 2023, no individual country outside the United States generated revenue that represented more than 10% of total revenue. The table below sets forth revenues for the Company’s two primary geographical markets, based on the geographic location to which its products are shipped (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 United States $ 171,650 $ 130,222 $ 458,122 $ 403,964 Outside the United States 72,321 55,400 199,433 146,958 Total Sales $ 243,971 $ 185,622 $ 657,555 $ 550,922 Sales to distributors accounted for 61 % and 62 % of the Company’s United States sales for the three and nine months ended September 30, 2024, respectively, and 64 % and 64 % of the Company’s United States sales for the three and nine months ended September 30, 2023, respectively. Sales to distributors accounted for the vast majority of the Company’s sales outside the United States for the three and nine-month periods ended September 30, 2024 and 2023. Revenues by Product During the three and nine months ended September 30, 2024 and 2023, sales by product were as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Pump $ 114,799 $ 88,037 $ 309,961 $ 274,415 Supplies and other 128,133 105,821 347,547 289,075 Net revenue recognized (deferred) for Tandem Choice program 1,039 ( 8,236 ) 47 ( 12,568 ) Total Sales $ 243,971 $ 185,622 657,555 550,922 21 12. Acquisitions AMF Medical Acquisition On December 10, 2022, the Company entered into a Share Purchase Agreement (Purchase Agreement) with AMF Medical SA, a corporation organized and existing under the laws of Switzerland (AMF Medical), and its shareholders to acquire all of the registered shares of AMF Medical (Transaction). AMF Medical is the developer of the Sigi Patch Pump, which is designed to be an ergonomic, rechargeable patch pump that reduces the burden of managing diabetes through its use of pre-filled insulin cartridges. The Sigi Patch Pump is under development and not commercially available. On January 19, 2023, the Company completed the acquisition of AMF Medical under the terms of the Purchase Agreement. The total aggregate consideration for the Transaction included a previous strategic investment of Swiss Francs (CHF) 8.0 million made in the third quarter of 2022, a cash payment of CHF 62.4 million paid at the closing of the Transaction, and additional contingent earnout payments of up to CHF 129.6 million. The contingent earnout payments become payable upon the achievement of certain milestones, and are comprised of a payment of up to CHF 38.4 million upon the successful completion of key development milestones over the two years following the closing date of the Transaction, and a payment of up to CHF 91.2 million upon obtaining regulatory clearance from the FDA of an automated controller enabled (ACE) pump. The contingent consideration will be recognized as each contingency is resolved and the respective consideration is paid or becomes payable. As of September 30, 2024, the contingencies related to the earnout milestones were not yet resolved and, therefore, the related amounts were not included in the fair value of the asset acquired and were not recognized as a liability on the consolidated balance sheet at September 30, 2024. The Company funded the initial closing payment using existing cash balances. The transaction was accounted for as an asset acquisition as substantially all the value of the gross assets was concentrated in a single asset. The Company recorded a $ 78.8 million charge in 2023 representing the value of acquired in-process research and development assets with no alternative future use, and acquisition related expenses, on its condensed consolidated statements of operations in acquired in-process research and development expenses. The Company’s results of operations included the operating results of AMF Medical since the date of acquisition. 13. Commitments and Contingencies Legal and Regulatory Matters On September 8, 2023, a purported stockholder of the Company filed a putative securities class action complaint (captioned Lowe v. Tandem Diabetes Care, Inc., et al., Case No. 23-cv-1657 (“ Lowe ”)) in the United States District Court for the Southern District of California against the Company and certain of the Company’s current executive officers (“defendants”). On December 6, 2023, the court appointed Mason Raines, Thomas O. Martel, and Linna Rae Martel to serve as co-lead plaintiffs (“plaintiffs”). On February 1, 2024, the plaintiffs filed their amended complaint. In the amended complaint, the plaintiffs alleged violations of the Securities Exchange Act of 1934, as amended, based on alleged materially false and misleading statements relating to our sales trends and financial forecasts. The plaintiffs sought to represent a class of persons who purchased or otherwise acquired Tandem common stock during the period between August 3, 2022, and November 2, 2022, inclusive. The plaintiffs also sought unspecified monetary damages, pre- and post-judgment interest, costs and fees, including attorneys’ fees and expert fees, and other relief. The defendants filed their motion to dismiss the amended complaint on March 11, 2024. The plaintiffs filed a response in opposition to defendants’ motion to dismiss on March 27, 2024, and on April 10, 2024, defendants filed their reply. On April 29, 2024, the court granted defendants’ motion to dismiss with leave to file a second amended complaint within 30 days. The plaintiffs did not file a second amended complaint within 30 days. On June 4, 2024, the Court entered final judgment dismissing the action in its entirety with prejudice. On July 5, 2024, the plaintiffs’ deadline to appeal the final judgment expired. Two shareholder derivative cases were filed in the United States District Court for the Southern District of California on March 29, 2024 (captioned Bushansky v. John F. Sheridan et al. , Case No. 24-cv-608) and on April 23, 2024 (captioned Amersi v. John F. Sheridan et al. , Case No. 24-cv-726) against the individual members of Tandem’s Board of Directors and the Company. These shareholder derivative lawsuits piggybacked on the Lowe case, and alleged that Tandem’s Board breached its fiduciary duties by failing to properly oversee and monitor the risks affecting the Company’s business, which resulted in reduced guidance, an associated stock drop, and the Lowe case. On May 16, 2024, the parties in the derivative actions filed a joint motion regarding consolidation and appointment of counsel. On June 13, 2024, the joint motion was granted and the derivative actions were consolidated. On July 12, 2024, the parties filed a joint request for voluntary dismissal of the consolidated derivative actions without prejudice. On the same day, July 12, 2024, the court granted the parties’ joint request and dismissed the consolidated derivative actions without prejudice. 22 From time to time, the Company is involved in various other legal proceedings, regulatory matters, and other disputes or claims arising from or related to claims incident to the normal course of the Company’s business activities, including actions with respect to intellectual property, data privacy, employment, regulatory, product liability and contractual matters. Although the results of such legal proceedings and claims cannot be predicted with certainty, as of September 30, 2024 the Company believes it is not currently a party to any legal proceedings, regulatory matters, or other disputes or claims for which a material loss was considered probable or for which the amount (or range) of loss was reasonably estimable. However, regardless of the merit of the claims raised or the outcome, legal proceedings may have an adverse impact on the Company as a result of defense and settlement costs, diversion of management time and resources, and other factors. Letters of Credit As of September 30, 2024, in connection with one of the Company’s operating leases (see Note 6, “Leases”), the Company had a $ 4.9 million unsecured irrevocable standby letter of credit arrangement with a bank, under which the landlord of the building is the beneficiary. The Company is required to maintain the standby letter of credit throughout the term of the lease, which expires in April 2035. 23