Item 1. Financial Statements
Item 1. Financial Statements
TANDEM DIABETES CARE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value)
March 31, December 31,
2022 2021
Assets (Unaudited) (Note 1)
Current assets:
Cash and cash equivalents $ 93,681 $ 71,181
Short-term investments 541,710 552,630
Accounts receivable, net 94,133 110,725
Inventories 79,987 68,551
Prepaid and other current assets 8,953 8,433
Total current assets 818,464 811,520
Property and equipment, net 49,987 50,386
Operating lease right-of-use assets 131,058 27,503
Other long-term assets 15,768 15,728
Total assets $ 1,015,277 $ 905,137
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 45,341 $ 28,032
Accrued expenses 6,362 9,419
Employee-related liabilities 38,258 51,556
Operating lease liabilities 8,080 9,279
Deferred revenue 10,881 10,182
Other current liabilities 22,893 23,388
Total current liabilities 131,815 131,856
Convertible senior notes, net - long-term 281,905 281,467
Operating lease liabilities - long-term 129,195 23,922
Deferred revenue - long-term 17,531 16,940
Other long-term liabilities 17,449 17,840
Total liabilities 577,895 472,025
Commitments and contingencies (Note 12) — —
Stockholders’ equity:
Common stock, $ 0.001 par value; 200,000 shares authorized, 63,941 and 63,833 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively.
64 64
Additional paid-in capital 1,089,689 1,068,259
Accumulated other comprehensive loss ( 3,061 ) ( 616 )
Accumulated deficit ( 649,310 ) ( 634,595 )
Total stockholders’ equity 437,382 433,112
Total liabilities and stockholders’ equity $ 1,015,277 $ 905,137
See accompanying notes to unaudited condensed consolidated financial statements.
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TANDEM DIABETES CARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except per share data)
Three Months Ended March 31,
2022 2021
Sales $ 175,907 $ 141,037
Cost of sales 84,814 67,750
Gross profit 91,093 73,287
Operating expenses:
Selling, general and administrative 73,271 58,563
Research and development 33,160 17,961
Total operating expenses 106,431 76,524
Operating loss ( 15,338 ) ( 3,237 )
Other income (expense), net:
Interest income and other, net 381 272
Interest expense ( 1,516 ) ( 1,506 )
Change in fair value of common stock warrants 34 ( 690 )
Total other expense, net ( 1,101 ) ( 1,924 )
Loss before income taxes ( 16,439 ) ( 5,161 )
Income tax benefit ( 1,724 ) ( 117 )
Net loss $ ( 14,715 ) $ ( 5,044 )
Other comprehensive loss:
Unrealized loss on short-term investments $ ( 2,517 ) $ ( 38 )
Foreign currency translation gain (loss) 72 ( 76 )
Comprehensive loss $ ( 17,160 ) $ ( 5,158 )
Net loss per share, basic and diluted $ ( 0.23 ) $ ( 0.08 )
Weighted average shares used to compute basic and diluted net loss per share 63,880 62,448
See accompanying notes to unaudited condensed consolidated financial statements.
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TANDEM DIABETES CARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands)
Three Months Ended March 31, 2022
Common Stock Additional
Paid-in
Capital Accumulated
Other
Comprehensive
Income (Loss) Accumulated
Deficit Total
Stockholders’
Equity
Shares Amount
Balance at December 31, 2021 63,833 $ 64 $ 1,068,259 $ ( 616 ) $ ( 634,595 ) $ 433,112
Exercise of stock options 101 — 3,782 — — 3,782
Vesting of restricted stock units, net of shares withheld for taxes 5 — ( 299 ) — — ( 299 )
Exercise of common stock warrants 2 — 16 — — 16
Stock-based compensation expense — — 17,931 — — 17,931
Unrealized loss on short-term investments — — — ( 2,517 ) — ( 2,517 )
Foreign currency translation adjustments — — — 72 — 72
Net loss — — — — ( 14,715 ) ( 14,715 )
Balance at March 31, 2022
63,941 $ 64 $ 1,089,689 $ ( 3,061 ) $ ( 649,310 ) $ 437,382
Three Months Ended March 31, 2021
Common Stock Additional
Paid-in
Capital Accumulated
Other
Comprehensive
Income (Loss)
Accumulated
Deficit Total
Stockholders’
Equity
Shares Amount
Balance at December 31, 2020 62,335 $ 62 $ 1,025,233 $ 220 $ ( 659,210 ) $ 366,305
Effect of change in accounting for convertible senior notes (1)
— — ( 85,803 ) — 9,049 ( 76,754 )
Exercise of stock options 111 1 3,135 — — 3,136
Exercise of common stock warrants 125 — 437 — — 437
Fair value of common stock warrants at time of exercise — — 12,434 — — 12,434
Stock-based compensation expense — — 13,014 — — 13,014
Unrealized loss on short-term investments — — — ( 38 ) — ( 38 )
Foreign currency translation adjustments — — — ( 76 ) — ( 76 )
Net loss — — — — ( 5,044 ) ( 5,044 )
Balance at March 31, 2021
62,571 $ 63 $ 968,450 $ 106 $ ( 655,205 ) $ 313,414
(1) The Company adopted ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity effective January 1, 2021 (see Note 2, “Summary of Significant Accounting Policies”).
See accompanying notes to unaudited condensed consolidated financial statements.
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TANDEM DIABETES CARE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
Three Months Ended March 31,
2022 2021
Operating Activities
Net loss $ ( 14,715 ) $ ( 5,044 )
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization expense 3,628 3,485
Amortization of debt issuance costs 438 428
Provision for expected credit losses 846 143
Provision for inventory obsolescence 346 64
Change in fair value of common stock warrants ( 34 ) 690
Amortization of premium on short-term investments 562 209
Stock-based compensation expense 18,110 12,947
Other 468 ( 73 )
Changes in operating assets and liabilities:
Accounts receivable, net 15,729 8,389
Inventories ( 11,963 ) ( 3,084 )
Prepaid and other current assets 741 ( 1,412 )
Other long-term assets ( 582 ) ( 17 )
Accounts payable & accrued expenses 13,732 10,815
Employee-related liabilities ( 13,299 ) ( 1,448 )
Deferred revenue 1,290 1,871
Operating leases and other current liabilities ( 1,106 ) 1,094
Other long-term liabilities ( 391 ) ( 372 )
Net cash provided by operating activities 13,800 28,685
Investing Activities
Purchases of short-term investments ( 110,719 ) ( 154,300 )
Proceeds from maturities of short-term investments 111,559 140,200
Proceeds from sales of short-term investments 7,000 11,530
Purchases of property and equipment ( 2,643 ) ( 3,524 )
Net cash provided by (used in) investing activities 5,197 ( 6,094 )
Financing Activities
Proceeds from issuance of common stock under Company stock plans, net 3,484 3,135
Proceeds from exercise of common stock warrants 16 438
Net cash provided by financing activities 3,500 3,573
Effect of foreign exchange rate changes on cash 3 14
Net increase in cash and cash equivalents 22,500 26,178
Cash and cash equivalents at beginning of period 71,181 94,613
Cash and cash equivalents at end of period $ 93,681 $ 120,791
Supplemental disclosures of cash flow information
Income taxes paid $ 170 $ 197
Supplemental schedule of non-cash investing and financing activities
Right-of-use assets obtained in exchange for operating lease obligations $ 107,478 $ 15,087
Purchase of property and equipment included in accounts payable $ 1,553 $ 924
Intangible costs in accounts payable and other long-term liabilities $ 1,029 $ 2,244
See accompanying notes to unaudited condensed consolidated financial statements.
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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 in the U.S., Canada and the Netherlands.
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’s manufacturing, sales and support activities principally focus on the t:slim X2 Insulin Delivery System (t:slim X2), the Company’s flagship pump platform which is capable of remote software updates and is designed to display continuous glucose monitoring (CGM) sensor information directly on the pump home screen. The Company’s insulin pump products are compatible with other complementary digital health offerings, such as the t:connect cloud-based diabetes management application (t:connect) and the Tandem Device Updater, a Mac and PC-compatible tool which offers and supports updates of the Company’s insulin pump software from a personal computer. The Company’s insulin pump 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 disposable products 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, as well as other accessories for enhanced usability.
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, 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, 2021 (Annual Report), from which the balance sheet information 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 subsidiary is the local currency. The Company translates the financial statements of its foreign subsidiary 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 loss, and in accumulated other comprehensive income 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.
Reclassifications
Starting with the first quarter of 2022, the Company included the liability related to common stock warrants (see Note 5, “Fair Value Measurements”) as a component of other current liabilities on the Company’s condensed consolidated balance sheet. In addition, deferred revenue long-term, which was previously reported as a component of other long-term liabilities, is now separately reported on the condensed consolidated balance sheet. The corresponding balances at December 31, 2021, have been reclassified to conform to the current year presentation .
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2. Summary of Significant Accounting Policies
There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2022, as compared to those disclosed in the Company’s 2021 Annual Report.
Use of Estimates
The preparation of the 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 consolidated financial statements and accompanying notes as of the date of the 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 risk, review of outstanding invoices, forecasts about the future, and various assumptions and estimates that are believed to be reasonable under the circumstances, which included the Company’s estimates of credit risks as a result of the coronavirus pandemic (COVID-19 global pandemic). 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.
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 carrying value and estimated fair value of certain of the Company’s common stock warrants was determined using the Black-Scholes pricing model as of March 31, 2022 and December 31, 2021 (see Note 5, “Fair Value Measurements”).
The Company’s convertible senior notes are carried at amortized cost on the condensed consolidated balance sheets (see Note 7, “Debt”). The Company determined the fair value of its convertible senior notes to be $ 363.3 million and $ 430.0 million at March 31, 2022 and December 31, 2021, respectively, based on Level 2 quoted market prices as of those dates .
Operating Lease Right-of-Use Assets and Liabilities
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 (the Commencement Date) based on the present value of lease payments over the lease term. For lease agreements entered into or reassessed after the adoption of ASC 842 Leases , the Company combines lease and non-lease components. 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 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.
Cost Basis Equity Investment
The Company made an $ 8.1 million equity investment in a private company in 2021, which represented less than 5 % of the outstanding equity of that company. The investment is recorded using the cost minus impairment adjusted for changes in observable prices and is included as a component of other long-term assets on the consolidated balance sheets. The Company monitors this investment 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.
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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 reviews its finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company did no t recognize any impairment losses during the three months ended March 31, 2022 and 2021.
In 2020, the Company acquired Sugarmate, Inc. (Sugarmate), the developer of a mobile app designed to help people visualize diabetes therapy data in innovative ways. The Sugarmate acquisition was accounted for as an acquisition of assets. Substantially all of the fair value was concentrated in a single identifiable asset, a technology-based intangible asset. The purchased intangible asset is amortized on a straight-line basis over an estimated useful life of five years .
Revenue Recognition
Revenue is generated primarily from sales of insulin pumps, disposable 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 returns.
Revenue Recognition for Arrangements with Multiple Performance Obligations
The Company considers the individual deliverables in its product offering as 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 t:connect and the Tandem Device Updater, 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.
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 disposable 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 utilizing historical experience. Insulin pumps returned to the Company may be refurbished and redeployed. Experience has shown that initial data for any given pump version may be insufficient; therefore, the Company’s process relies on long-term historical averages 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 the length of time each pump version has been in the field and revised future expectations of performance based on new features and capabilities that may become available through Tandem Device Updater.
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The following table provides a reconciliation of the changes in product warranty liabilities for the three months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
2022 2021
Balance at beginning of the period $ 30,401 $ 22,075
Provision for warranties issued during the period 7,201 5,896
Settlements made during the period ( 6,021 ) ( 4,256 )
Decrease in warranty estimates ( 1,137 ) ( 546 )
Balance at end of the period $ 30,444 $ 23,169
As of March 31, 2022 and December 31, 2021, total product warranty reserves were included in the following consolidated balance sheet accounts (in thousands):
March 31, 2022 December 31, 2021
Other current liabilities $ 13,509 $ 13,076
Other long-term liabilities 16,935 17,325
Total warranty reserve $ 30,444 $ 30,401
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 Amended and Restated 2013 Stock Incentive Plan (2013 Plan) and the fair value of the employees’ purchase rights under the Company’s 2013 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 2013 Plan 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 issued under the 2013 Plan that vest based upon the Company’s actual performance relative to predefined performance metrics is 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, subject to the awardee’s continuing service through the measurement date. 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 Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net 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 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 common stock warrants that are recorded as a liability in the accompanying condensed consolidated balance sheets, the calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the warrants and the presumed exercise of the warrants is dilutive to loss per share for the period, an adjustment is made to net loss used in the calculation to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method.
For the three months ended March 31, 2022 and 2021, 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.
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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
March 31,
2022 2021
Options to purchase common stock 4,424 5,068
Unvested restricted stock units 630 133
Warrants to purchase common stock 211 379
Awards granted under the ESPP 78 78
Convertible senior notes (if-converted) 2,554 2,554
7,897 8,212
Recent Accounting Pronouncements
In June 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in
an Entity’s Own Equity , which is intended to simplify the accounting for convertible instruments. This new guidance eliminated certain models that require separate accounting for embedded conversion features, and eliminated certain of the conditions for equity classification for contracts in an entity’s own equity. Accordingly, a convertible debt instrument will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. The new guidance could be adopted through either a modified retrospective method of transition or a fully retrospective method of transition. ASU 2020-06 is effective for public business entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company elected to early adopt the new standard on January 1, 2021 using the modified retrospective method and, accordingly, recorded a net reduction to accumulated deficit of $ 9.0 million, a decrease to additional paid-in capital of $ 85.8 million, and an increase to convertible senior notes, net - long-term of $ 76.8 million to reflect the impact of the accounting change (see Note 7, “Debt”).
3. Short-Term Investments
The Company invests in marketable securities primarily consisting of debt instruments of the U.S. Government, U.S. 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 March 31, 2022 and December 31, 2021 (in thousands):
At March 31, 2022 Amortized
Cost Gross Unrealized
Gain Gross Unrealized
Loss Estimated
Fair Value
Available-for-sale securities:
U.S. Treasury securities $ 296,072 $ 1 $ ( 2,388 ) $ 293,685
Commercial paper 156,913 — ( 202 ) 156,711
Corporate debt securities 51,649 6 ( 196 ) 51,459
U.S. Government-sponsored enterprises 37,217 — ( 362 ) 36,855
Supranational bonds 3,000 — — 3,000
Total $ 544,851 $ 7 $ ( 3,148 ) $ 541,710
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At December 31, 2021 Amortized
Cost Gross Unrealized
Gain Gross Unrealized
Loss Estimated
Fair Value
Available-for-sale securities:
U.S. Treasury securities $ 222,206 $ — $ ( 482 ) $ 221,724
Commercial paper 218,391 14 ( 24 ) 218,381
Corporate debt securities 58,881 — ( 45 ) 58,836
U.S. Government-sponsored enterprises 50,773 1 ( 88 ) 50,686
Supranational bonds 3,003 — — 3,003
Total $ 553,254 $ 15 $ ( 639 ) $ 552,630
The contractual maturities of available-for-sale debt securities as of March 31, 2022, were as follows (in thousands):
Years to Maturity
At March 31, 2022 Within One Year One to Two Years Estimated Fair Value
U.S. Treasury securities $ 223,643 $ 70,042 $ 293,685
Commercial paper 156,711 — 156,711
Corporate debt securities 43,906 7,553 51,459
U.S. Government-sponsored enterprises 23,612 13,243 36,855
Supranational bonds 3,000 — 3,000
Total $ 450,872 $ 90,838 $ 541,710
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 March 31, 2022 were primarily due to the recent increase in market interest rates. The Company does not intend to sell the available-for-sale debt securities that are in an unrealized loss position, and it is not more likely than not that the Company will be required to sell these debt securities before recovery of their amortized cost bases, which may be at maturity. Based on the credit quality of the available-for-sale debt securities in an unrealized loss position, and the Company’s estimates of future cash flows to be collected from those securities, the Company believes the unrealized losses are not credit losses. Accordingly, the Company did not recognize any impairment losses related to its available-for-sale debt securities at March 31, 2022.
4. Composition of Certain Financial Statement Items
Accounts Receivable
Accounts receivable, net consisted of the following at (in thousands):
March 31, 2022 December 31, 2021
Accounts receivable $ 98,477 $ 114,974
Less: allowance for credit losses ( 4,344 ) ( 4,249 )
Accounts receivable, net $ 94,133 $ 110,725
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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 months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
2022 2021
Balance at beginning of the period $ 4,249 $ 3,857
Provision for expected credit losses 846 143
Write-offs and adjustments, net of recoveries ( 751 ) ( 441 )
Balance at end of the period $ 4,344 $ 3,559
Inventories
Inventories consisted of the following at (in thousands):
March 31, 2022 December 31, 2021
Raw materials $ 28,223 $ 26,911
Work-in-process 18,520 16,612
Finished goods 33,244 25,028
Total inventories $ 79,987 $ 68,551
5. Fair Value Measurements
Authoritative guidance on fair value measurements defines fair value, and provides a consistent framework for measuring fair value and for disclosures of each major asset and liability category measured at fair value on either a recurring or a nonrecurring basis. Fair value is intended to reflect an assumed exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the authoritative guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly for substantially the full term of the asset or liability.
Level 3: Unobservable inputs in which there is little or no market data and that are significant to the fair value of the assets or liabilities, which require the reporting entity to develop its own valuation techniques that require input assumptions.
The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2022 and December 31, 2021, and indicates the fair value hierarchy of the valuation techniques utilized by the Company to determine such fair value (in thousands):
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Fair Value Measurements at
March 31, 2022
Total Level 1 Level 2 Level 3
Assets
Cash equivalents (1)
$ 44,905 $ 44,905 $ — $ —
U.S. Treasury securities 293,685 293,685 — —
Commercial paper 156,711 — 156,711 —
Corporate debt securities 51,459 — 51,459 —
U.S. Government-sponsored enterprises 36,855 — 36,855 —
Supranational bonds 3,000 — 3,000 —
Total assets $ 586,615 $ 338,590 $ 248,025 $ —
Liabilities
Common stock warrants (2)
$ 113 $ — $ — $ 113
Total liabilities $ 113 $ — $ — $ 113
Fair Value Measurements at
December 31, 2021
Total Level 1 Level 2 Level 3
Assets
Cash equivalents (1)
$ 48,286 $ 48,286 $ — $ —
U.S. Treasury securities 221,724 221,724 — —
Commercial paper 218,381 — 218,381 —
Corporate debt securities 58,836 — 58,836 —
U.S. Government-sponsored enterprises 50,686 — 50,686 —
Supranational bonds 3,003 — 3,003 —
Total assets $ 600,916 $ 270,010 $ 330,906 $ —
Liabilities
Common stock warrants (2)
$ 147 $ — $ — $ 147
Total liabilities $ 147 $ — $ — $ 147
(1) Generally, cash equivalents include money market funds and investments with a maturity of three months or less from the date of purchase.
(2) Included in other current liabilities on the Company’s condensed consolidated balance sheets.
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.
The Company's Level 3 liabilities at March 31, 2022 and December 31, 2021 included the remaining Series A warrants issued by the Company in connection with the public offering of common stock in October 2017. The Series A warrants, which expire in October 2022, provide holders the right to purchase shares of the Company’s common stock at an exercise price of $ 3.50 per share. As of March 31, 2022 and December 31, 2021, there were Series A warrants outstanding to purchase 1,000 shares of the Company’s common stock (see Note 8, “Stockholders’ Equity”).
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The Company reassesses the fair value of the outstanding Series A warrants at each reporting date utilizing a Black-Scholes pricing model. Variables used in the pricing model include the closing market price of the Company’s common stock at the balance sheet date, as well as estimated stock price volatility, dividend yield, remaining warrant term and risk-free interest rate. A significant increase (decrease) in any of these inputs in isolation, particularly the market price of the Company’s common stock, would have resulted in a significantly higher (lower) fair value measurement . The assumptions used to estimate the fair values of the outstanding Series A warrants at March 31, 2022 and December 31, 2021 are presented below:
Series A Warrants
March 31, 2022 December 31, 2021
Risk-free interest rate 1.1 % 0.3 %
Expected dividend yield 0.0 % 0.0 %
Expected volatility 44.4 % 39.1 %
Expected term (in years) 0.6 0.8
The following table presents a summary of changes in the fair value of the Company’s Level 3 financial liabilities for the three months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
2022 2021
Balance at beginning of period $ 147 $ 14,261
(Gain) loss recognized from the change in fair value of common stock warrants ( 34 ) 690
Common stock warrants exercised during the period — ( 12,434 )
Balance at end of period $ 113 $ 2,517
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 . Leases with an initial term of 12 months or less (Short-term Lease) are expensed as incurred and are not recorded as right-of-use assets on the Company’s condensed consolidated balance sheets. The Company is required to recognize operating lease right-of-use assets and liabilities, and begin recording lease expense when the Company takes possession of the leased property (the Commencement Date). The Company recognizes lease expense for these leases on a straight-line basis over the lease term. Because the Company’s leases do not provide an implicit interest rate, the Company uses its incremental borrowing rate based on the information available at the lease Commencement Date to determine the operating lease right-of-use assets and liabilities based on the present value of future lease payments over the lease term. The Company used the incremental borrowing rate on January 1, 2019 for operating leases that commenced prior to that date.
Certain leases include an option to renew, with renewal terms that can extend the lease term for additional periods. The exercise of lease renewal options is at the Company’s sole discretion. For renewal options that are reasonably certain at the lease Commencement Date of being exercised, the Company includes the renewal option period in the lease term.
Vista Sorrento Lease
In March 2021, the Company entered into a second amendment (Second Amendment) to its lease agreement for office space located on Vista Sorrento Parkway in San Diego, California (Vista Sorrento Lease) covering 59,013 square feet of general administrative office space (Existing Premises). The Second Amendment expanded the Existing Premises by adding 14,916 square feet of general administrative office space (Expansion Space), and extended the lease term for the Existing Premises through January 2028. The Expansion Space lease Commencement Date occurred in March 2021, and the lease term expires in January 2028. The Company has two options to extend the term of the Vista Sorrento Lease, covering both the Existing Premises and the Expansion Space, with each option providing for an additional period of five years . The Vista Sorrento Lease term was determined assuming the renewal options would not be exercised. The Company recognized right-of-use leased assets and corresponding operating lease liabilities of $ 15.1 million on the consolidated balance sheet in the first quarter of 2021 related to the Second Amendment.
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Tech Center Lease
In September 2021, the Company entered into a lease agreement for 181,949 square feet of additional general administrative, laboratory, and research and development office space (the Premises) located on High Bluff Drive in San Diego, California (Tech Center Lease). Possession of the Premises is expected to be tendered to the Company by the landlord in two phases, with Phase I consisting of 143,850 rentable square feet, and Phase II consisting of 38,099 rentable square feet. The Company intends to use Phase I of the Tech Center Lease for operations currently occupying 77,458 square feet of leased space, located on Roselle Street in San Diego, California, that is scheduled to expire in May 2023.
The initial lease term Phase I Commencement Date occurred in March 2022 when the Company was tendered possession of the Phase I portion of the Premises, and rent payments commence in September 2022 (the Phase I Rent Commencement Date). The Phase II Commencement Date is expected to occur upon the earlier of (i) the date upon which the Company first commences business in the Phase II portion of the Premises, and (ii) May 1, 2025 (the Phase II Rent Commencement Date). The Tech Center Lease term expires in April 2035. The Company has two options to extend the term of the lease, with each option providing for an additional period of five years . The Tech Center Lease term was determined assuming the renewal options would not be exercised.
The Tech Center Lease also includes a first right of offer with respect to an additional 34,569 rentable square feet of general office space should the space become available. The lease term and associated base rent for the additional space will not be known until the Company is notified that the additional space has become available, and the Company elects to lease the space on terms mutually satisfactory to the Company and the landlord.
The initial base rent for the Tech Center Lease is approximately $ 906,000 per month beginning on the Phase I Rent Commencement Date, and the base rent increases by approximately $ 255,000 per month on the Phase II Rent Commencement Date. The monthly base rent will increase by 3.0 % on each annual anniversary of the respective Rent Commencement Date. In addition to the monthly base rent, the Company is required to pay its proportionate share of certain ongoing operating expenses throughout the duration of the lease. No base rent, other than the proportionate share of operating expenses, will be due for the Phase I portion of the Premises for months two through nine following the Phase I Rent Commencement Date, and for the Phase II portion of the Premises for months two through five following the Phase II Rent Commencement Date. The Company recognized right-of-use leased assets and corresponding operating lease liabilities of $ 107.5 million on the consolidated balance sheet on the Phase I Commencement Date in the first quarter of 2022.
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 March 31,
2022 2021
Operating lease cost $ 3,018 $ 2,006
Short-term lease cost 34 22
Total lease cost $ 3,052 $ 2,028
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Maturities of operating lease liabilities at March 31, 2022 were as follows (in thousands):
Years Ending December 31,
2022 (remaining) $ 6,387
2023 12,805
2024 17,057
2025 17,475
2026 17,528
Thereafter 120,235
Total undiscounted lease payments 191,487
Less: amount representing interest ( 54,212 )
Present value of operating lease liabilities 137,275
Less: current portion of operating lease liabilities ( 8,080 )
Operating lease liabilities - long-term $ 129,195
The weighted-average remaining lease term and weighted-average discount rate for operating leases were as follows:
March 31, 2022 December 31, 2021
Weighted-average remaining lease term (in years) 11.2 5.0
Weighted-average discount rate used to determine operating lease liabilities 5.4 % 5.6 %
Cash paid for amounts included in the measurement of lease liabilities, representing operating cash flows from operating leases, was $ 3.4 million and $ 2.3 million for the three months ended March 31, 2022 and 2021, respectively .
Leases For Which Accounting Has Not Yet Commenced
As of March 31, 2022, the Commencement Date for the High Bluff Lease described below, and Phase II of the Tech Center Lease, had not yet occurred. Accordingly, the condensed consolidated balance sheet at March 31, 2022 does not include operating lease right-of-use assets and operating lease liabilities, and the condensed consolidated statement of operations for the three months ended March 31, 2022 does not include any lease costs, related to the High Bluff Lease and Phase II of the Tech Center Lease. In addition, the above disclosures of the Company’s lease costs, maturities of operating lease liabilities, and the weighted-average remaining lease term and weighted-average discount rate, do not include any amounts related to the High Bluff Lease and Phase II of the Tech Center Lease.
High Bluff Lease
In May 2021, the Company entered into a lease agreement for approximately 31,372 square feet of general office space located on High Bluff Drive, in San Diego, California (High Bluff Lease). The High Bluff Lease is a direct lease agreement for the same property subject to the High Bluff sublease. The lease term begins in April 2022 following the termination of the High Bluff sublease in March 2022, and is scheduled to expire in March 2024. The Company expects to recognize right-of-use leased assets and corresponding operating lease liabilities of approximately $ 3.0 million on the consolidated balance sheet on the Commencement Date in the second quarter of 2022.
Tech Center Lease - Phase II
The Company currently estimates that Phase II Commencement Date will occur in the first quarter of 2025, at which time the Phase II operating lease right-of-use assets and liabilities will be recorded. Future minimum payments for monthly base rent due under Phase II of the Tech Center Lease, are currently estimated to total $ 34.7 million from 2025 through 2035, subject to a number of factors, including the actual Commencement Date of Phase II. Because the incremental borrowing rate will not be available until the Phase II Commencement Date, we are not yet able to determine the Phase II operating lease right-of-use assets and liabilities.
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7. Debt
Convertible Senior Notes
In May 2020, the Company entered into a purchase agreement with certain counterparties for the sale of an aggregate of $ 287.5 million principal amount of 1.50 % Convertible Senior Notes due 2025 (Notes) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. 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.
The 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 Notes mature on May 1, 2025 unless repurchased, redeemed, or converted in accordance with their terms prior to the maturity date.
The 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 Notes, which is equivalent to an initial conversion price of $ 112.57 (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. The Company expects to settle conversions through a combination settlement, which involves payment in cash equal to the principal portion and delivery of shares of common stock for the excess of the conversion value over the principal portion.
The Company may not redeem the Notes prior to May 6, 2023. The Company has the option to redeem for cash all or any portion of the 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 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 Notes to be redeemed, plus accrued and unpaid interest. No sinking fund is provided for the Notes.
Holders of the Notes may convert all or a portion of their Notes at their option prior to November 1, 2024, in multiples of $1,000 principal amounts, only under the following circumstances:
• if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the applicable conversion price of the Notes on each such trading day;
• during the five business day period after any five consecutive trading day period in which the trading price per $1,000 principal amount of the Notes for each day of that five consecutive trading day 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 Notes on such trading day;
• if the Company calls any or all of the Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or
• on the occurrence of specified corporate events.
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.
Holders of the 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 Notes may require us to repurchase all or a portion of the Notes at a price equal to 100 % of the principal amount of the Notes, plus any accrued and unpaid interest.
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The net carrying amount of the Notes on the condensed consolidated balance sheets consisted of the following (in thousands):
March 31, 2022 December 31, 2021
Principal amount $ 287,500 $ 287,500
Unamortized debt issuance costs ( 5,595 ) ( 6,033 )
Net carrying amount $ 281,905 $ 281,467
As of March 31, 2022, the unamortized debt issuance costs of $ 5.6 million associated with the Notes will be amortized to interest expense, at an effective interest rate of 2.2 % over the remaining period of approximately three years .
The following table details interest expense recognized related to the Notes for the three months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended
March 31, 2022 March 31, 2021
Contractual interest expense $ 1,078 $ 1,078
Amortization of debt issuance costs 438 428
Total interest expense $ 1,516 $ 1,506
The Notes will have a dilutive effect to the extent the average market price per share of common stock for a given reporting period exceeds the conversion price of $ 112.57 . As of March 31, 2022, the if-converted value of the Notes exceeded the principal amount by $ 9.5 million. As of December 31, 2021, the if-converted value of the Notes exceeded the principal amount by $ 96.9 million.
Capped Call Transactions
In connection with the issuance of the Notes, the Company entered into Capped Call Transactions in May 2020 with certain counterparties at a net cost of $ 34.1 million. The Capped Call Transactions are intended to reduce potential dilution to holders of the Company’s common stock beyond the conversion price of $ 112.57 , up to a conversion price of $ 173.18 on any conversion of the Notes, or to offset any cash payments the Company is required to make in excess of the principal amount of such converted Notes, as the case may be, with such reduction or offset subject to a cap. The cap price of the Capped Call Transactions is initially $ 173.18 per share of the Company’s common stock, representing a premium of 100 % above the last reported sale price of $ 86.59 per share of the Company’s common stock on May 12, 2020, and is subject to certain adjustments under the terms of the Capped Call Transactions. Conditions that cause adjustments to the initial strike price of the Capped Call Transactions mirror conditions that result in corresponding adjustments for the Notes.
For accounting purposes, the Capped Call Transactions are separate transactions, and not part of the terms of the Notes, while they are integrated for federal tax purposes. As these transactions met certain criteria under the applicable accounting guidance, the Capped Call Transactions were recorded in stockholders' equity and were not accounted for as derivatives. The cost of the Capped Call Transactions was recorded as a reduction of the Company’s additional paid-in capital in the Company’s consolidated balance sheet and will not be remeasured.
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8. Stockholders’ Equity
Shares Reserved for Future Issuance
The following shares of the Company's common stock were reserved for future issuance at March 31, 2022 (in thousands):
Shares reserved for issuance upon conversion of Convertible Senior Notes 2,554
Shares underlying outstanding warrants 211
Shares underlying outstanding stock options 4,671
Shares underlying unvested restricted stock units 772
Shares authorized for issuance pursuant to awards granted under the ESPP 1,216
Shares authorized for future equity award grants 1,258
Total 10,682
Common Stock Warrants
Warrants outstanding to purchase shares of the Company's common stock as of March 31, 2022 were as follows:
Issue Date Exercise Price Per Share Warrants Outstanding Expiration Date of Warrants Outstanding
October 2017 $ 3.50 1,000 October 2022
March 2017 $ 23.50 193,788 March 2027
August 2011 - August 2012 $ 73.73 16,212 May 2022 - August 2022
211,000
Each warrant allows the holder to purchase one share of the Company's common stock at the exercise price per share of the respective warrant. The Company issued 1,835 and 125,000 shares of its common stock upon the exercise of warrants during the three months ended March 31, 2022 and 2021, respectively.
Stock Plans
The Company’s Amended and Restated 2013 Stock Incentive Plan (2013 Plan) was originally approved by the Company’s board of directors in October 2013. Under the 2013 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 ESPP enables eligible employees to purchase shares of the Company’s common stock using their after-tax payroll deductions, subject to certain conditions. Generally, offerings under the ESPP consist of a two-year offering period with four six-month purchase periods which begin in May and November of each year. There were no shares of common stock purchased under the ESPP during the three months ended March 31, 2022 and 2021.
Stock-Based Compensation
Common Stock Options
Common stock options have an exercise price equal to the closing price of the Company's common stock on the applicable award date, and have a maximum term of ten years . Stock options granted generally vest over a four year period as to 25 % of the underlying shares on the first anniversary of the award, with the balance of the options vesting monthly over the following three years .
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The Company estimates the fair value of stock options using the Black-Scholes option-pricing model on the grant date. The number of common stock options granted and the respective assumptions used in the Black-Scholes option-pricing model were as follows:
Three Months Ended March 31,
2022 2021
Stock options granted — 115,400
Weighted average grant date fair value (per share) N/A $ 60.98
Risk-free interest rate N/A 0.9 %
Expected dividend yield N/A 0.0 %
Expected volatility N/A 75.6 %
Expected term (in years) N/A 6.1
Restricted Stock Units
Restricted stock units (RSUs) have a grant price equal to the closing price of the Company’s common stock on the award date. RSUs granted prior to March 2022, generally vest over a four year period based only on service as to 25 % of the underlying shares on the first anniversary of the award, with the balance of the RSUs vesting quarterly over the following three years . RSUs granted in March 2022 vest over a three year period based only on service as to 33 % of the underlying shares on the first anniversary of the award, with the balance of the RSUs vesting quarterly over the following two years .
The number of RSUs granted and the respective weighted average grant date fair value were as follows:
Three Months Ended
March 31,
2022 2021
RSUs granted 187,076 3,208
Weighted average grant date fair value (per share) $ 109.97 $ 93.49
The following table summarizes the allocation of stock-based compensation expense included in the consolidated statements of operations for all stock-based compensation arrangements (in thousands):
Three Months Ended March 31,
2022 2021
Cost of sales $ 1,846 $ 1,476
Selling, general & administrative 11,854 9,409
Research and development 4,410 2,062
Total stock-based compensation expense $ 18,110 $ 12,947
The total stock-based compensation capitalized as part of the cost of the Company’s inventories was $ 0.8 million and $ 1.0 million at March 31, 2022 and December 31, 2021, respectively.
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 rehire 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. The Company did not provide a matching contribution prior to 2022, but began making a discretionary match in the first quarter of 2022.
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10. Income Taxes
For the three months ended March 31, 2022, the Company recognized an income tax benefit of $ 1.7 million on a pre-tax loss of $ 16.4 million, compared to an income tax benefit of $ 0.1 million on a pre-tax loss of $ 5.2 million for the three months ended March 31, 2021. The income tax benefit for the three months ended March 31, 2022 and 2021, was primarily attributable to the Company’s pre-tax loss position, offset by state and foreign income tax expense as a result of current taxable income in certain jurisdictions.
The Company calculated the provision (benefit) for income taxes for the three months ended March 31, 2022 and 2021, 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 March 31, 2022, based on the current assessment that it is not more likely than not these future benefits will be realized before expiration.
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, disposable 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, including in select European countries, Canada, Australia, New Zealand, Saudi Arabia and South Africa. In the United States and Canada, the Company utilizes a direct sales force. The Company disaggregates its revenue by geography and by major sales channel 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 months ended March 31, 2022 and 2021, 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 March 31,
2022 2021
United States $ 131,283 $ 103,339
Outside the United States 44,624 37,698
Total Sales $ 175,907 $ 141,037
Sales to distributors accounted for 65 % and 68 % of the Company’s total United States sales for the three months ended March 31, 2022 and 2021, respectively. Sales to distributors accounted for 96 % and 96 % of the Company’s total sales outside the United States for the three months ended March 31, 2022 and 2021, respectively.
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12. Commitments and Contingencies
Legal and Regulatory Matters
In May 2020, the Company was named as a defendant in three California state court class action lawsuits arising from the same data breach. Collectively, these lawsuits seek statutory, compensatory, actual, and punitive damages; equitable relief, including restitution; pre- and post-judgment interest; injunctive relief; and attorney fees, costs, and expenses from the Company. On July 24, 2020, these three pending lawsuits were consolidated into a single case in the Superior Court of the State of California in the County of San Bernardino entitled Joseph Deluna et al v. Tandem Diabetes Care, Inc . The consolidated case alleges violations of the Confidentiality of Medical Information Act (CMIA), California Consumer Privacy Act (CCPA), California’s Unfair Competition Law (UCL), and breach of contract. The Company filed a demurrer seeking dismissal of all claims, which was heard by the Court on October 27, 2020, and which resulted in the following outcome: (i) the demurrer to the CMIA claim was denied; (ii) the demurrer to the CCPA claim was sustained; and (iii) the demurrer to the UCL and contract claims were sustained with leave to amend the pending complaint. A second demurrer was heard by the Court on March 29, 2021 with the following outcome: (i) the demurrer to the CMIA claim was denied; and (ii) the demurrer to the UCL and contract claims was sustained without leave to amend as to three of the named plaintiffs. The plaintiffs filed a motion for class certification on January 7, 2021 to which the Company filed its opposition on April 11, 2022. The Company filed a motion for summary adjudication on the CMIA claim on April 7, 2021, which is still pending. Although the Company continues to vigorously defend against these claims, there is no guarantee that the Company will prevail. The Company presently is unable to determine the ultimate outcome of these lawsuits or determine the amount (or range) of possible losses associated with the lawsuits.
In September 2020, the Company was named as a defendant in a lawsuit entitled Buck Walsh, individually and on behalf of others similarly situated v. Tandem Diabetes Care, Inc., which was filed in the Superior Court of the State of California in the County of San Diego. The alleged violations include business and professions code and labor code violations for failure to compensate wages, unpaid meal and rest periods, and failure to reimburse for necessary business-related expenses. The case was brought as a class action and was later amended to also include a representative action under the California Private Attorney General Act, or PAGA. The class of plaintiffs includes hourly paid or non-exempt employees of the Company who were employed from April 6, 2016 through the date of adjudication. The parties recently agreed to resolve all claims in the lawsuit. The settlement of claims covered by the PAGA matter were approved by the Superior Court of the State of California in the County of San Diego on September 21, 2021 and settlement amounts were disbursed in 2021. In October 2021, a settlement of the class action related claims was preliminarily approved by an independent arbitrator mutually acceptable to both parties. The class action is intended to resolve the claims of the individual plaintiff, as well as the remaining members of the class, unless an individual class member submits a timely request for exclusion. The material terms of the settlement are set forth in a binding Memorandum of Agreement dated as of July 1, 2021, which was approved by the independent arbitrator on April 18, 2022. Subsequent to this filing, the Company anticipates receipt of the final settlement amount from the settlement administrator. This lawsuit will be resolved and closed upon disbursement of the settlement amount.
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 the normal course of its business activities, including actions with respect to intellectual property, data privacy, employment, regulatory, product liability and contractual matters. Although the results of legal proceedings, disputes and other claims cannot be predicted with certainty, the Company believes it is not currently a party to any other legal proceeding(s) which, if determined adversely to the Company, would, individually or taken together, have a material adverse effect on the Company’s business, operating results, financial condition or cash flows. 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.
Except as set forth above, as of March 31, 2022, there were no 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 merits of the claims raised or the outcome, legal proceedings, regulatory matters, and other disputes and claims may have an adverse impact on the Company because of as a result of defense and settlement costs, diversion of management time and resources, and other factors.
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Letters of Credit
The Company leases general office space, research and development, manufacturing and warehouse facilities, and equipment under noncancelable operating leases for use in its operations (see Note 6, “Leases”). In connection with one of the operating leases, the Company has 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.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.