Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 30, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Current Fiscal Year End Date | --12-31 | |
Document Transition Report | false | |
Entity File Number | 001-38847 | |
Entity Registrant Name | SILK ROAD MEDICAL, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-8777622 | |
Entity Address, Address Line One | 1213 Innsbruck Dr. | |
Entity Address, City or Town | Sunnyvale | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94089 | |
City Area Code | 408 | |
Local Phone Number | 720-9002 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | SILK | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 39,443,868 | |
Entity Central Index Key | 0001397702 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 22,629 | $ 20,210 |
Short-term investments | 151,833 | 161,264 |
Accounts receivable, net | 27,203 | 23,573 |
Inventories | 30,486 | 29,876 |
Prepaid expenses and other current assets | 3,543 | 5,912 |
Total current assets | 235,694 | 240,835 |
Long-term investments | 2,027 | 9,456 |
Property and equipment, net | 8,085 | 8,114 |
Other non-current assets | 6,508 | 6,904 |
Total assets | 252,314 | 265,309 |
Current liabilities: | ||
Accounts payable | 2,966 | 5,676 |
Accrued liabilities | 18,371 | 24,607 |
Total current liabilities | 21,337 | 30,283 |
Long-term debt | 75,886 | 75,626 |
Other liabilities | 7,806 | 8,249 |
Total liabilities | 105,029 | 114,158 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value Shares authorized: 5,000,000 at March 31, 2024 and December 31, 2023 Shares issued and outstanding: none at March 31, 2024 and December 31, 2023 | ||
Common stock, $0.001 par value Shares authorized: 100,000,000 at March 31, 2024 and December 31, 2023 Shares issued and outstanding: 39,436,634 and 39,165,481 at March 31, 2024 and December 31, 2023, respectively | 39 | 39 |
Additional paid-in capital | 560,854 | 550,495 |
Accumulated other comprehensive income (loss) | (17) | 72 |
Accumulated deficit | (413,591) | (399,455) |
Total stockholders’ equity | 147,285 | 151,151 |
Total liabilities and stockholders’ equity | $ 252,314 | $ 265,309 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Preferred stock, $0.001 par value | ||
Preferred shares (in USD per share) | $ 0.001 | $ 0.001 |
Preferred shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, $0.001 par value | ||
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 39,436,634 | 39,165,481 |
Shares outstanding (in shares) | 39,436,634 | 39,165,481 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Condensed Statements of Operations and Comprehensive Loss [Abstract] | ||
Revenue | $ 48,484 | $ 40,131 |
Cost of goods sold | 11,983 | 12,526 |
Gross profit | 36,501 | 27,605 |
Operating expenses: | ||
Research and development | 10,660 | 10,433 |
Selling, general and administrative | 40,775 | 34,082 |
Total operating expenses | 51,435 | 44,515 |
Loss from operations | (14,934) | (16,910) |
Interest income | 2,471 | 2,287 |
Interest expense | (1,721) | (1,693) |
Other income (expense), net | 48 | (144) |
Net loss | (14,136) | (16,460) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on investments, net | (89) | 249 |
Other comprehensive income (loss) | (89) | 249 |
Comprehensive loss | $ (14,225) | $ (16,211) |
Net loss per share, basic | $ (0.36) | $ (0.43) |
Net loss per share, diluted | $ (0.36) | $ (0.43) |
Weighted average common shares used to compute net loss per share, basic | 39,261,496 | 38,532,202 |
Weighted average common shares used to compute net loss per share, diluted | 39,261,496 | 38,532,202 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Total |
Beginning balance (in shares) at Dec. 31, 2022 | 38,355,972 | ||||
Beginning balance at Dec. 31, 2022 | $ 38 | $ 507,715 | $ (343,712) | $ (166) | $ 163,875 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options | 1,110 | 1,110 | |||
Exercise of stock options (in shares) | 144,474 | ||||
Issuance of common stock upon vesting of restricted stock units | $ 1 | 1 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 207,995 | ||||
Stock-based compensation | 8,838 | 8,838 | |||
Net loss | (16,460) | (16,460) | |||
Unrealized gain (loss) on investments, net | 249 | 249 | |||
Ending balance (in shares) at Mar. 31, 2023 | 38,708,441 | ||||
Ending balance at Mar. 31, 2023 | $ 39 | 517,663 | (360,172) | 83 | 157,613 |
Beginning balance (in shares) at Dec. 31, 2023 | 39,165,481 | ||||
Beginning balance at Dec. 31, 2023 | $ 39 | 550,495 | (399,455) | 72 | 151,151 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 271,153 | ||||
Stock-based compensation | 10,359 | 10,359 | |||
Net loss | (14,136) | (14,136) | |||
Unrealized gain (loss) on investments, net | (89) | (89) | |||
Ending balance (in shares) at Mar. 31, 2024 | 39,436,634 | ||||
Ending balance at Mar. 31, 2024 | $ 39 | $ 560,854 | $ (413,591) | $ (17) | $ 147,285 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net loss | $ (14,136) | $ (16,460) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 644 | 699 |
Stock-based compensation expense | 10,359 | 8,838 |
Accretion of discounts on investments, net | (1,359) | (1,753) |
Amortization of debt discount and debt issuance costs | 59 | 57 |
Amortization of right-of-use asset | 281 | 281 |
Non-cash interest expense | 222 | 218 |
Loss on disposal of property and equipment | 144 | |
Provision for doubtful accounts receivable | 19 | |
Provision for excess and obsolete inventories | 175 | 1 |
Changes in assets and liabilities: | ||
Accounts receivable | (3,630) | (1,968) |
Inventories | (785) | 2,109 |
Prepaid expenses and other current assets | 2,369 | (124) |
Other assets | 115 | (17) |
Accounts payable | (2,937) | 2,668 |
Accrued liabilities | (6,256) | (6,388) |
Other liabilities | (443) | (471) |
Net cash used in operating activities | (15,322) | (12,147) |
Cash flows from investing activities | ||
Purchases of property and equipment | (388) | (287) |
Purchases of investments | (43,871) | (26,407) |
Proceeds from maturity of investments | 62,000 | 32,800 |
Net cash provided by investing activities | 17,741 | 6,106 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock | 1,110 | |
Net cash provided by financing activities | 1,110 | |
Net change in cash, cash equivalents and restricted cash | 2,419 | (4,931) |
Cash, cash equivalents and restricted cash, beginning of period | 20,210 | 55,513 |
Cash, cash equivalents and restricted cash, end of period | 22,629 | 50,582 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,440 | 1,418 |
Noncash investing and financing activities: | ||
Accounts payable and accrued liabilities for purchases of property and equipment | $ 227 | $ 58 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2024 | |
Organization [Abstract] | |
Organization | 1. Organization The Company Silk Road Medical, Inc., or the Company, has developed a technologically advanced, minimally-invasive solution for patients with carotid artery disease who are at risk for stroke. The Company's portfolio of products enable a procedure referred to as transcarotid artery revascularization, or TCAR, that combines the benefits of endovascular techniques and surgical principles. The Company manufactures and sells in the United States its portfolio of TCAR products which are designed to provide direct access to the carotid artery, effective reduction in stroke risk throughout the procedure, and long-term restraint of carotid plaque. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The accompanying financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the condensed balance sheet as of December 31, 2023, and related disclosures, have been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s condensed financial information. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. The accompanying interim unaudited condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company's annual report on Form 10-K filed with the SEC on February 28, 2024. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses judgment when making estimates related to provisions for accounts receivable and excess and obsolete inventories, the valuation of deferred tax assets, the reserves for sales returns, and stock-based compensation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Fair Value of Financial Instruments The Company has evaluated the estimated fair value of its financial instruments as of March 31, 2024 and December 31, 2023. The carrying amounts of certain of the Company’s financial instruments, which include accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are recorded at fair value, based on quoted market prices. As of March 31, 2024 and December 31, 2023, the Company’s cash equivalents were entirely comprised of investments in money market funds. Investments Short-term and long-term investments consist of debt securities classified as available-for-sale. Short-term investment have original maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are recorded at fair value based on the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). Realized gains and losses are included in earnings and are derived based on the specific-identification method for determining the costs of investments sold and were insignificant for the three months ended March 31, 2024 and 2023. Amortization of premiums and accretion of discounts are reported as a component of interest income. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the investment. The Company evaluates the securities in an unrealized loss position for expected credit losses by considering factors such as historical experience, market data, issuer-specific factors, current economic conditions and credit ratings. The Company did no t recognize any credit losses on its available-for-sale securities during the three months ended March 31, 2024 and 2023. Concentration of Credit Risk, and Other Risks and Uncertainties Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds. The Company invests in a variety of financial instruments, such as, but not limited to, commercial paper, corporate bonds/notes, U.S. government securities, U.S. treasury bills, agency bonds/notes and, by policy, limits the amount of credit exposure with any one financial institution or commercial issuer. The Company has not experienced any material losses on its deposits of cash and cash equivalents or investments during the three months ended March 31, 2024 and 2023. As of March 31, 2024 and December 31, 2023, a portion of the Company’s cash and cash equivalents was maintained with Silicon Valley Bank, a division of First Citizens Bank, or SVB, and exceeded federally insured limits. Substantially all of the Company’s cash equivalents and investments reside in a custodial account held by a third party, in which SVB Asset Management is the advisor. As of the issuance date of these financial statements, the Company has not experienced any losses on its deposits. The Company’s accounts receivable are due from a variety of hospitals and medical centers in the United States. As of March 31, 2024 and December 31, 2023, no customer represented 10% or more of the Company’s accounts receivable. For the three months ended March 31, 2024 and 2023, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for expected credit losses on customer accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s finished goods, components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE Transcarotid Stent System, manufactured by Cordis Corporation, or Cordis. Disruption in finished goods, component or sub-assembly supply from these manufacturers or from in-house production would have a negative impact on the Company’s financial position and results of operations. The Company is subject to certain risks, including that its devices may not be approved or cleared for marketing by governmental authorities or be successfully marketed. There can be no assurance that the Company’s products will achieve widespread adoption in the marketplace, nor can there be any assurance that existing devices or any future devices can be developed or manufactured at an acceptable cost and with appropriate performance characteristics. The Company is also subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, competition, dependence upon government and third-party payers to provide adequate coverage and reimbursement, dependence on key personnel and suppliers, protection of proprietary technology, product liability claims, and compliance with government regulations. Existing or future devices developed by the Company may require approvals or clearances from the U.S. Food and Drug Administration, or FDA, or international regulatory agencies. In addition, in order to continue the Company’s operations, compliance with various federal and state laws is required. If the Company were denied or delayed in receiving such approvals or clearances, it may be necessary to adjust operations to align with the Company’s currently approved portfolio. If clearance for the products in the current portfolio were withdrawn by the FDA, this would have a material adverse impact on the Company. Leases The Company accounts for its leasing arrangements in accordance with Accounting Standards Codification, or ASC 842, “Leases.” The Company considers if an arrangement is a lease at inception if it obtains the right to control the use of an identified asset under a leasing arrangement with an initial term greater than twelve months. The Company determines whether a contract conveys the right to control the use of an identified asset for a period of time if the contract contains both the right to obtain substantially all of the economic benefits from the use of the identified asset and the right to direct the use of the identified asset. The Company also evaluates the nature of each lease to determine whether it is an operating or financing lease and recognizes the right-of-use asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The Company considers renewal options in the determination of the lease term if the option to renew is reasonably certain. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease costs, which consists primarily of taxes, insurance and common area maintenance costs, are expensed as incurred. The Company elected to account for contracts that contain lease and non-lease components as a single component, consistent with its historical practice. The Company does not have any finance leases. Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, "Revenue from Contracts with Customers." Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company’s revenue is generated from the sale of its products to hospitals and medical centers in the United States through direct sales representatives and is primarily comprised of product revenue net of returns, administration fees and sales rebates. Revenue is recognized when obligations under the terms of a contract with customers are satisfied, which occurs with the transfer of control of the Company’s products to its customers, either upon shipment of the product or delivery of the product to the customer. The Company’s products are readily available for usage as soon as the customer possesses it. Upon receipt, the customer controls the economic benefits of the product, has significant risks and rewards, and the legal title. The Company has present right to payment; therefore, the transfer of control is deemed to happen at a point in time. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring the goods. The Company is entitled to the total consideration for the products ordered by customers as product pricing is fixed according to the terms of customer contracts and payment terms are short. Administration fees and sales rebates are accounted for as a reduction in revenue, calculated based on the terms agreed to with the customer. As of March 31, 2024 and December 31, 2023, the Company recorded $ 379,000 and $ 227,000 , respectively, of unbilled receivables, which are included in accounts receivable, net on the condensed balance sheet, as the Company has an unconditional right to payment as of the end of the applicable period. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price. Costs associated with product sales, which include commissions and royalties, are expensed when incurred because the expense is incurred at a point in time and the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of goods sold in the condensed statements of operations and comprehensive loss. The Company accepts product returns at its discretion or if the product is defective as manufactured. The Company establishes estimated provisions for returns based on historical experience and considers other factors that it believes could significantly impact its expected returns, which provisions are classified within accrued liabilities on the condensed balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its California and Minnesota facilities and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and sub-assemblies, manufacturing overhead costs, direct labor, scrap, product rework, reserves for excess, obsolete and non-sellable inventories as well as logistics-related expenses. A significant portion of the Company’s cost of goods sold currently consists of manufacturing overhead costs. These overhead costs include the cost of quality control, material procurement, inventory control, facilities, equipment and operations supervision and management. Cost of goods sold also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalties. Stock–Based Compensation The Company accounts for stock-based compensation in accordance with Financial Accounting Standards Board, or FASB, ASC 718, "Compensation-Stock Compensation." ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options, restricted stock units, performance stock units, and shares issued under its employee stock purchase plan. ASC 718 requires companies to estimate the fair value of all share-based payment option awards on the date of grant using an option pricing model. The fair value of stock options is recognized over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period (usually the vesting period), on a straight-line basis. The Company accounts for option forfeitures as they occur. The Company accounts for stock-based compensation for restricted stock units at their fair value, based on the closing market price of the Company’s common stock on the date of grant. These costs are recognized on a straight-line basis over the requisite service period, which is usually the vesting period. The Company accounts for stock-based compensation for performance stock units with market-based conditions at their fair value on the date of the award using the Monte Carlo simulation model. These costs are recognized over the requisite service period, which is usually the vesting period, regardless of the likelihood of achievement of the market-based performance criteria. The Company accounts for stock-based compensation for its employee stock purchase plan based on the estimated fair value on the first day of the offering period using an option pricing model for each purchase period. These costs are recognized on a straight-line basis over the offering period. Income Taxes The Company accounts for income taxes under the liability method, whereby deferred tax assets and liabilities are determined based on the difference between the condensed financial statements and tax bases of assets and liabilities using the enacted tax rates in effect for the year in which the differences are expected to affect taxable income. A valuation allowance is established when necessary to reduce deferred tax assets to the amounts expected to be realized. As the Company has historically incurred operating losses, it has established a full valuation allowance against its net deferred tax assets, and there is no provision for income taxes. The Company also follows the provisions of ASC 740-10, "Accounting for Uncertainty in Income Taxes." ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or expected to be taken on a tax return. No liability related to uncertain tax positions is recorded on the condensed financial statements. It is the Company's policy to include penalties and interest expense related to income taxes as part of the provision for income taxes. Comprehensive Loss Comprehensive loss consists of net loss and changes in unrealized gains and losses on investments classified as available-for-sale. For the three months ended March 31, 2024 and 2023 , the Company’s unrealized gains and losses on available-for-sale investments represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the condensed statements of operations and comprehensive loss. Accumulated other comprehensive income (loss) is presented in the accompanying condensed balance sheets as a component of stockholders' equity. Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock options, restricted stock units and performance stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. Net loss per share was determined as follows (in thousands, except share and per share data): Three Months Ended March 31, 2024 2023 Net loss $ ( 14,136 ) $ ( 16,460 ) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 39,261,496 38,532,202 Net loss per share, basic and diluted $ ( 0.36 ) $ ( 0.43 ) The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an antidilutive impact due to the Company's net loss: March 31, 2024 2023 Common stock options 3,617,465 3,689,853 Restricted stock units and performance stock units 4,512,326 1,692,645 Total 8,129,791 5,382,498 Segment and Geographical Information The Company operates and manages its business as one reportable and operating segment. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. Primarily all of the Company’s long-lived assets are based in the United States. Long-lived assets are comprised of property and equipment. All of the Company’s revenue was in the United States for the three months ended March 31, 2024 and 2023, based on the shipping location of the external customer. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 3 Months Ended |
Mar. 31, 2024 | |
Recent Accounting Pronouncements [Abstract] | |
Recent Accounting Pronouncements | 3. Recent Accounting Pronouncements Recently Issued Accounting Standards In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or ASU 2023-07, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segments expenses. ASU 2023-07 became effective for the Company on January 1, 2024. The adoption of ASU 2023-07 did not have a material impact on the Company’s segment reporting disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, or ASU 2023-09, which enhances income tax disclosure requirements by requiring specified categories and greater disaggregation within the rate reconciliation table, disclosure of income taxes paid by jurisdiction, and providing clarification on uncertain tax positions and related financial statement impacts. ASU 2023-09 is effective for the Company on January 1, 2025 with early adoption permitted. The Company is currently evaluating the impact of adoption of this new guidance on its income tax disclosures.. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents and investments. Fair value is an 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 a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: • Level 1 – quoted prices in active markets for identical assets and liabilities; • Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; • Level 3 – unobservable inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The Company’s investments are classified within Level 1 of the fair value hierarchy include money market funds valued using quoted market prices and U.S. treasury bills valued using broker or dealer quotations with reasonable levels of price transparency. Investments classified within Level 2 include commercial paper, which are valued using model-based valuation techniques, and corporate bonds/notes, U.S. government securities and agency bonds/notes, which are valued based upon quoted market prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The following tables set forth by level within the fair value hierarchy the Company’s assets that are reported at fair value as of March 31, 2024 and December 31, 2023, using the inputs defined above (in thousands): March 31, 2024 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 22,355 $ — $ — $ 22,355 U.S. treasury bills 8,911 — — 8,911 Commercial paper — 12,568 — 12,568 Corporate bonds/notes — 28,522 — 28,522 U.S. government securities — 56,970 — 56,970 Agency bonds/notes — 46,889 — 46,889 Total $ 31,266 $ 144,949 $ — $ 176,215 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 19,483 $ — $ — $ 19,483 U.S. treasury bills 11,899 — — 11,899 Commercial paper — 33,150 — 33,150 Corporate bonds/notes — 39,438 — 39,438 U.S. government securities — 17,556 — 17,556 Agency bonds/notes — 68,677 — 68,677 Total $ 31,382 $ 158,821 $ — $ 190,203 There were no transfers between fair value hierarchy levels during the three months ended March 31, 2024 and 2023. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Components [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Investments The fair value of the Company’s available-for-sale investments as of March 31, 2024 and December 31, 2023 are as follows (in thousands): March 31, 2024 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 22,355 $ — $ — $ 22,355 U.S. treasury bills 8,914 — ( 3 ) 8,911 Commercial paper 12,573 — ( 5 ) 12,568 Corporate bonds/notes 28,505 19 ( 2 ) 28,522 U.S. government securities 56,983 10 ( 23 ) 56,970 Agency bonds/notes 46,903 4 ( 18 ) 46,889 Total $ 176,233 $ 33 $ ( 51 ) $ 176,215 Classified as: Cash equivalents $ 22,355 Short-term investments 151,833 Long-term investments 2,027 Total $ 176,215 December 31, 2023 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 19,483 $ — $ — $ 19,483 U.S. treasury bills 11,896 3 — 11,899 Commercial paper 33,160 5 ( 15 ) 33,150 Corporate bonds/notes 39,398 55 ( 15 ) 39,438 U.S. government securities 17,501 55 — 17,556 Agency bonds/notes 68,693 27 ( 43 ) 68,677 Total $ 190,131 $ 145 $ ( 73 ) $ 190,203 Classified as: Cash equivalents $ 19,483 Short-term investments 161,264 Long-term investments 9,456 Total $ 190,203 The following table summarizes the fair value of the Company’s cash equivalents, and available-for-sale investments classified by maturity as of March 31, 2024 and December 31, 2023 (in thousands): March 31, December 31, 2024 2023 Amounts maturing within one year $ 174,188 $ 180,747 Amounts maturing after one year through two years 2,027 9,456 Total $ 176,215 $ 190,203 Available-for-sale investments held as of March 31, 2024 had a weighted average days to maturity of 146 days. The following table presents the Company’s available-for-sale investments that were in an unrealized loss position as of March 31, 2024 and December 31, 2023 (in thousands): March 31, 2024 December 31, 2023 Less than 12 months Less than 12 months Assets: Fair Value Unrealized Loss Fair Value Unrealized Loss U.S. treasury bills $ 4,913 $ ( 3 ) $ — $ — Commercial paper 12,568 ( 5 ) 19,684 ( 15 ) Corporate bonds/notes 8,985 ( 2 ) 21,842 ( 15 ) U.S. government securities 34,194 ( 23 ) — — Agency bonds/notes 28,271 ( 18 ) 48,964 ( 43 ) Total $ 88,931 $ ( 51 ) $ 90,490 $ ( 73 ) There were no available-for-sale investments in an unrealized loss position greater than twelve months as of March 31, 2024, and December 31, 2023. Inventories Components of inventories were as follows (in thousands): March 31, December 31, 2024 2023 Raw materials $ 5,993 $ 6,512 Finished products 24,493 23,364 Total inventories $ 30,486 $ 29,876 As of March 31, 2024 and December 31, 2023, there were no work-in-process inventories. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): March 31, December 31, 2024 2023 Accrued payroll and related expenses $ 11,855 $ 17,113 Operating lease liability 1,701 1,703 Accrued travel expenses 1,109 944 Provision for sales returns 589 500 Accrued interest payable 517 517 Accrued royalty expense 428 405 Accrued administration fees and sales rebates 414 405 Accrued professional services 411 326 Accrued clinical expenses 339 256 Deferred revenue 317 143 Accrued other expenses 691 2,295 Total accrued liabilities $ 18,371 $ 24,607 |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2024 | |
Long-term Debt [Abstract] | |
Long-term Debt | 6. Long-term Debt In May 2022, the Company entered into a Loan and Security Agreement, or Loan Agreement, with Oxford Finance LLC and its agents, or Oxford Finance, which provides for a $ 225,000,000 loan facility, comprised of a $ 25,000,000 secured revolving credit facility and a $ 200,000,000 secured term loan facility. The term loans are available in three tranches. The first $ 75,000,000 tranche of term loans was available at closing in May 2022. A second tranche of $ 75,000,000 of term loans is available through December 31, 2024. A third tranche of $ 50,000,000 would be available through December 31, 2024 so long as, at the time of draw, the Company has consolidated trailing 12-month revenues equal to at least 90 % of the sum of the outstanding term loans plus the amount of any requested third tranche term loans. Upon request of the Company, the revolving credit facility will be increased from $ 25,000,000 to $ 50,000,000 . The revolving loans are available subject to a borrowing base equal to 85 % of eligible receivables plus 50 % of eligible inventory, up to the lesser of 40 % of the borrowing base or $ 10,000,000 , in the case of eligible inventory. The revolving loans and the term loans mature on May 1, 2027 . The principal amount of outstanding revolving loans, together with accrued and unpaid interest, is due on the maturity date. The term loans begin to amortize in equal monthly installments beginning on July 1, 2026. As the Company achieved a specified consolidated trailing twelve-month revenue target, it has the option to extend the first amortization date for the term loans to July 1, 2027. Such election may be made no later than thirty (30) days prior to July 1, 2026. If the Company exercises this option, then the maturity date for both the revolving loans and the term loans will be May 1, 2028. The revolving loans accrue interest at the greater of 1-month Secured Overnight Financing Rate (SOFR), or the Index Rate, and 0.85 %, plus a margin of 3.00 %. The term loans accrue interest at the greater of the Index Rate and 0.85 %, plus a margin of 5.00 %. The Index Rate is capped at 2.50 % for purposes of the Loan Agreement. Interest on both revolving loans and term loans is payable monthly in arrears. The Company may borrow, prepay and reborrow revolving loans, without premium or penalty. The term loans once repaid or prepaid may not be reborrowed. Term loans may be prepaid in full, or in part in increments of $ 10,000,000 . The Company is required to pay a prepayment fee of 3.0 % for prepayments of term loans made in the first year after closing, 2.0 % for prepayments of term loans made in the second year after closing, 1.0 % for prepayments of term loans made in the third year after closing and no prepayment fees thereafter. Upon the earlier of prepayment or maturity of the term loans, the Company is required to pay a fee of 5.0 % of the aggregate original principal amount of the funded term loans, which fee increases to 6.75 % if the Company exercises its option to extend the amortization date and maturity date. The Company is also obligated to pay other customary fees for a loan facility of this size and type. Also in May 2022, the Company borrowed the first $ 75,000,000 tranche of the term loan and used a portion of the proceeds to pay off and terminate the prior term loan agreement with Stifel Bank totaling $ 49,181,000 , which included a final interest payment of $ 181,000 . The Company recognized a loss on debt extinguishment of $ 245,000 in connection with the early termination of its prior term loan agreement with Stifel Bank. The Success Fee Agreement obligation, of $ 367,500 , survives the Stifel Bank debt repayment and terminates on October 29, 2025. Obligations under the Loan Agreement are secured by substantially all of the Company’s assets. The Loan Agreement requires the Company to maintain consolidated trailing twelve-month revenues of at least 75 % of the outstanding principal amount of the term loans, measured as of the last day of each fiscal quarter; or if the revenue target is not achieved, the Company must have maintained unrestricted cash and cash equivalents (net of outstanding revolving loans) subject to control agreements in favor of Oxford Finance equal to at least 50 % of the outstanding principal amount of the term loans . Additionally, the Loan Agreement contains customary affirmative and negative covenants, including covenants limiting the Company’s ability and the ability of the Company’s subsidiaries to, among other things, dispose of assets, effect certain mergers, incur debt, grant liens, pay dividends and distributions on capital stock, make investments and acquisitions, and enter into transactions with affiliates, in each case subject to customary exceptions for a loan facility of this size and type. The events of default under the Loan Agreement include, among others, payment defaults, material misrepresentations, breaches of covenants, cross defaults with certain other material indebtedness, bankruptcy and insolvency events, and judgment defaults. The occurrence of an event of default could result in the acceleration of the Company’s obligations under the Loan Agreement, the termination of the lender’s commitments, a 5 % increase in the applicable rate of interest and the exercise by the lender of other rights and remedies provided for under the Loan Agreement. As of March 31, 2024, the aggregate outstanding principal balance under the term loan facility was $ 75,000,000 with the variable interest rate capped at the maximum rate of 7.50 %, and no amounts were outstanding under the revolving credit facility of the Loan Agreement. As of March 31, 2024, the Company was in compliance with all applicable financial covenants. Future payments under the Oxford Finance term loan agreement as of March 31, 2024 are as follows (in thousands): Period Ending December 31: Amount 2024 $ 4,297 2025 5,703 2026 45,699 2027 34,518 90,217 Add: Accretion of closing fees 1,530 91,747 Less: Amount representing interest ( 15,216 ) Less: Amount representing debt discount and debt issuance costs ( 645 ) Present value of minimum payments $ 75,886 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Lease and Rights-of-Use The Company’s operating lease obligation at its corporate headquarters in California consists of leased office, laboratory, and manufacturing space under a non-cancellable operating lease that expires in October 2027. In May 2023, the Company extended the lease term for an additional three years and recorded an additional $ 2,504,000 right-of-use asset and lease liability from the remeasurement. The lease agreement includes a renewal provision allowing the Company to extend this lease for an additional period of five years . The Company’s non-cancelable operating lease obligation at its facility in Minnesota consists of additional office, laboratory and manufacturing space and expires in November 2029. The lease agreement includes a renewal provision allowing the Company to extend this lease for two additional five year terms. Balance sheet information as of March 31, 2024 and December 31, 2023 consists of the following (in thousands): March 31, December 31, Operating Lease: 2024 2023 Operating lease right-of-use assets in other non-current assets $ 6,208 $ 6,489 Operating lease liabilities in accrued liabilities $ 1,701 $ 1,703 Operating lease liabilities in other liabilities 6,968 7,304 Total operating lease liabilities $ 8,669 $ 9,007 The following table summarizes the Company’s operating lease payments as of March 31, 2024 (in thousands): Period Ending December 31: Amount 2024 $ 1,492 2025 2,130 2026 2,255 2027 2,068 2028 and thereafter 2,391 Total lease payments $ 10,336 Less: imputed interest ( 1,667 ) Present value of lease liabilities $ 8,669 Purchase Obligations Purchase obligations consist of agreements to purchase goods and services entered into in the ordinary course of business. As of March 31, 2024, the Company had non-cancellable purchase obligations to suppliers of $ 27,032,000 . In addition, the Company has minimum purchase commitments under its amended supply agreement with Cordis from July 2025 through February 2029 which require a specified minimum volume commitment based on the actual units purchased during the prior year period from July 1 through June 30, with the unit purchase price dependent upon annual volume during the same prior year period. Indemnification In the normal course of business, the Company enters into contracts and agreements with suppliers and other parties that contain a variety of representations and warranties and may provide for indemnification of the counterparty. The Company’s exposure under these agreements is unknown because it involves claims that may be made against it in the future but have not yet been made. To date, the Company has not been subject to any claims or been required to defend any action related to its indemnification obligations. The Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the director or officer is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and bylaws. The term of the indemnification period lasts as long as a director or officer may be subject to any proceeding arising out of acts or omissions of such director or officer in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has no t recognized any liabilities relating to these obligations as of March 31, 2024. Contingencies The Company is not involved in any pending legal proceedings that it believes could have a material adverse effect on its financial condition, results of operations or cash flows. From time to time, the Company may pursue litigation to assert its legal rights and such litigation may be costly and divert the efforts and attention of its management and technical personnel which could adversely affect its business. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There were no contingent liabilities requiring accrual as of March 31, 2024 and December 31, 2023. |
Stock-Based Compensation Plans
Stock-Based Compensation Plans | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation Plans [Abstract] | |
Stock-Based Compensation Plans | 8. Stock-Based Compensation Plans As of March 31, 2024, the Company has reserved 9,518,753 shares of common stock for issuance under the 2019 Equity Incentive Plan, or the 2019 Plan. A summary of the shares available for issuance under the 2019 Plan is as follows: Number of Shares Balances, December 31, 2023 532,627 Authorized 1,566,619 Allowance for PSU for overperformance ( 111,641 ) Granted / Awarded ( 1,282,295 ) Cancelled 50,232 Balances, March 31, 2024 755,542 Stock option activity under the Company’s 2007 Stock Option Plan, 2015 Equity Incentive Plan and 2019 Plan is set forth below: Options Outstanding Number of Weighted Average Weighted Average Remaining Contractual Term Aggregate Intrinsic Shares Exercise Price (Years) Value Balances, December 31, 2023 3,632,684 $ 25.02 5.52 $ 7,942,439 Options granted — $ — Options exercised — $ — Options cancelled ( 15,219 ) $ 41.43 Balances, March 31, 2024 3,617,465 $ 24.95 5.24 $ 16,441,732 Vested and exercisable at March 31, 2024 3,268,983 $ 23.10 4.97 $ 16,441,732 Vested and expected to vest at March 31, 2024 3,617,465 $ 24.95 5.24 $ 16,441,732 There was no aggregate intrinsic value of options exercised during the three months ended March 31, 2024. The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the estimated fair value of the common stock on the date of exercise. Restricted Stock Units Restricted stock units, or RSUs, are granted under the 2019 Plan and generally vest over four years in annual equal increments. A summary of RSU activity for the three months ended March 31, 2024 is as follows: Number of Restricted Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2023 2,726,972 $ 26.02 Awards granted 1,170,654 $ 17.14 Awards vested ( 271,153 ) $ 42.52 Awards canceled ( 35,013 ) $ 38.06 Balances, March 31, 2024 3,591,460 $ 21.76 Expected to vest at March 31, 2024 3,591,460 $ 21.76 Performance Stock Units Performance stock units, or PSUs, are granted under the 2019 Plan and generally vest over three years . A summary of PSU activity for the three months ended March 31, 2024 is as follows: Number of Performance Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2023 809,225 $ 27.86 Awards granted 111,641 $ 28.71 Awards vested — $ — Awards canceled — $ — Balances, March 31, 2024 920,866 $ 27.96 Expected to vest at March 31, 2024 920,866 $ 27.96 The number of awards granted and the number of shares expected to vest in the table above as of March 31, 2024 reflect the performance and vesting of PSUs at 100 % of the target value of shares granted. 2019 Employee Stock Purchase Plan As of March 31, 2024, 465,952 shares of common stock have been issued to employees participating in the 2019 Employee Stock Purchase Plan, or the ESPP, and 1,748,117 shares were available for future issuance under the ESPP. Stock-Based Compensation In March 2024, the Company awarded an aggregate of 111,641 PSUs, assuming target performance. Up to one-third of the target award can be earned and vested at the end of each of the one-year and two-year performance periods based on the total stockholder return, or TSR, of the Company’s common stock price relative to a group of peer companies, and up to 200 % of the target award at the end of the three-year performance measurement period. The fair value of the PSUs was estimated using the Monte Carlo simulation model and the following assumptions: peer companies volatility of 57.6 %, Company volatility of 72.7 %, risk-free interest rate of 4.27 %, correlation with index of 0.35 , and dividend yield of 0 %. The following table summarizes the total stock-based compensation expense included in the condensed statements of operations and comprehensive loss for all periods presented (in thousands): Three Months Ended March 31, 2024 2023 Cost of goods sold $ 439 $ 390 Research and development expenses 2,119 1,632 Selling, general and administrative expenses 7,801 6,816 Total stock-based compensation expense $ 10,359 $ 8,838 As of March 31, 2024, there was total unrecognized compensation costs of $ 4,267,000 related to stock options expected to be recognized over a period of approximately 1.55 years, a total of $ 86,470,000 of unrecognized compensation costs related to unvested RSUs and PSUs expected to be recognized over a period of approximately 2.87 years and $ 236,000 of unrecognized compensation costs related to the ESPP, which the Company will recognize over 0.13 years. |
401(k) Plan
401(k) Plan | 3 Months Ended |
Mar. 31, 2024 | |
401(k) Plan [Abstract] | |
401(k) Plan | 9. 401(k) Plan The Company has a qualified retirement plan under section 401(k) of the Internal Revenue Code, or the IRC, under which participants may contribute up to 90 % of their eligible compensation, subject to maximum deferral limits specified by the IRC. The Company may make a discretionary matching contribution to the 401(k) plan and may make a discretionary employer contribution to each eligible employee each year. The Company matches employees' contributions to the 401(k) plan at 50 % of the first 6 % of compensation deferred to the 401(k) plan. The Company's matching contributions were $ 778,000 and $ 683,000 for the three months ended March 31, 2024 and 2023, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Basis of Preparation | Basis of Preparation The accompanying financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the condensed balance sheet as of December 31, 2023, and related disclosures, have been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s condensed financial information. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. The accompanying interim unaudited condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company's annual report on Form 10-K filed with the SEC on February 28, 2024. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses judgment when making estimates related to provisions for accounts receivable and excess and obsolete inventories, the valuation of deferred tax assets, the reserves for sales returns, and stock-based compensation. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately differ from these estimates and assumptions. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company has evaluated the estimated fair value of its financial instruments as of March 31, 2024 and December 31, 2023. The carrying amounts of certain of the Company’s financial instruments, which include accounts receivable, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these instruments. Management believes that its debt bears interest at the prevailing market rates for instruments with similar characteristics (Level 2 within the fair value hierarchy); accordingly, the carrying value of this instrument approximates its fair value. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents are recorded at fair value, based on quoted market prices. As of March 31, 2024 and December 31, 2023, the Company’s cash equivalents were entirely comprised of investments in money market funds. |
Investments | Investments Short-term and long-term investments consist of debt securities classified as available-for-sale. Short-term investment have original maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are recorded at fair value based on the fair value hierarchy. Unrealized gains and losses, deemed temporary in nature, are reported as a separate component of accumulated other comprehensive income (loss). Realized gains and losses are included in earnings and are derived based on the specific-identification method for determining the costs of investments sold and were insignificant for the three months ended March 31, 2024 and 2023. Amortization of premiums and accretion of discounts are reported as a component of interest income. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the investment. The Company evaluates the securities in an unrealized loss position for expected credit losses by considering factors such as historical experience, market data, issuer-specific factors, current economic conditions and credit ratings. The Company did no t recognize any credit losses on its available-for-sale securities during the three months ended March 31, 2024 and 2023. |
Concentration of Credit Risk, and Other Risks and Uncertainties | Concentration of Credit Risk, and Other Risks and Uncertainties Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents, investments and accounts receivable to the extent of the amounts recorded on the balance sheet. Cash, cash equivalents, and investments are deposited in financial institutions which, at times, may be in excess of federally insured limits. Cash equivalents are invested in highly rated money market funds. The Company invests in a variety of financial instruments, such as, but not limited to, commercial paper, corporate bonds/notes, U.S. government securities, U.S. treasury bills, agency bonds/notes and, by policy, limits the amount of credit exposure with any one financial institution or commercial issuer. The Company has not experienced any material losses on its deposits of cash and cash equivalents or investments during the three months ended March 31, 2024 and 2023. As of March 31, 2024 and December 31, 2023, a portion of the Company’s cash and cash equivalents was maintained with Silicon Valley Bank, a division of First Citizens Bank, or SVB, and exceeded federally insured limits. Substantially all of the Company’s cash equivalents and investments reside in a custodial account held by a third party, in which SVB Asset Management is the advisor. As of the issuance date of these financial statements, the Company has not experienced any losses on its deposits. The Company’s accounts receivable are due from a variety of hospitals and medical centers in the United States. As of March 31, 2024 and December 31, 2023, no customer represented 10% or more of the Company’s accounts receivable. For the three months ended March 31, 2024 and 2023, there were no customers that represented 10% or more of revenue. The Company provides for uncollectible amounts when specific credit problems are identified. In doing so, the Company analyzes historical bad debt trends, customer credit worthiness, current economic trends and changes in customer payment patterns when evaluating the adequacy of the allowance for expected credit losses on customer accounts. The Company manufactures certain of its commercial products in-house. Certain of the Company’s finished goods, components and sub-assemblies continue to be manufactured by sole suppliers, the most significant of which is the ENROUTE Transcarotid Stent System, manufactured by Cordis Corporation, or Cordis. Disruption in finished goods, component or sub-assembly supply from these manufacturers or from in-house production would have a negative impact on the Company’s financial position and results of operations. The Company is subject to certain risks, including that its devices may not be approved or cleared for marketing by governmental authorities or be successfully marketed. There can be no assurance that the Company’s products will achieve widespread adoption in the marketplace, nor can there be any assurance that existing devices or any future devices can be developed or manufactured at an acceptable cost and with appropriate performance characteristics. The Company is also subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, competition, dependence upon government and third-party payers to provide adequate coverage and reimbursement, dependence on key personnel and suppliers, protection of proprietary technology, product liability claims, and compliance with government regulations. Existing or future devices developed by the Company may require approvals or clearances from the U.S. Food and Drug Administration, or FDA, or international regulatory agencies. In addition, in order to continue the Company’s operations, compliance with various federal and state laws is required. If the Company were denied or delayed in receiving such approvals or clearances, it may be necessary to adjust operations to align with the Company’s currently approved portfolio. If clearance for the products in the current portfolio were withdrawn by the FDA, this would have a material adverse impact on the Company. |
Leases | Leases The Company accounts for its leasing arrangements in accordance with Accounting Standards Codification, or ASC 842, “Leases.” The Company considers if an arrangement is a lease at inception if it obtains the right to control the use of an identified asset under a leasing arrangement with an initial term greater than twelve months. The Company determines whether a contract conveys the right to control the use of an identified asset for a period of time if the contract contains both the right to obtain substantially all of the economic benefits from the use of the identified asset and the right to direct the use of the identified asset. The Company also evaluates the nature of each lease to determine whether it is an operating or financing lease and recognizes the right-of-use asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The Company considers renewal options in the determination of the lease term if the option to renew is reasonably certain. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease costs, which consists primarily of taxes, insurance and common area maintenance costs, are expensed as incurred. The Company elected to account for contracts that contain lease and non-lease components as a single component, consistent with its historical practice. The Company does not have any finance leases. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, "Revenue from Contracts with Customers." Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company’s revenue is generated from the sale of its products to hospitals and medical centers in the United States through direct sales representatives and is primarily comprised of product revenue net of returns, administration fees and sales rebates. Revenue is recognized when obligations under the terms of a contract with customers are satisfied, which occurs with the transfer of control of the Company’s products to its customers, either upon shipment of the product or delivery of the product to the customer. The Company’s products are readily available for usage as soon as the customer possesses it. Upon receipt, the customer controls the economic benefits of the product, has significant risks and rewards, and the legal title. The Company has present right to payment; therefore, the transfer of control is deemed to happen at a point in time. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring the goods. The Company is entitled to the total consideration for the products ordered by customers as product pricing is fixed according to the terms of customer contracts and payment terms are short. Administration fees and sales rebates are accounted for as a reduction in revenue, calculated based on the terms agreed to with the customer. As of March 31, 2024 and December 31, 2023, the Company recorded $ 379,000 and $ 227,000 , respectively, of unbilled receivables, which are included in accounts receivable, net on the condensed balance sheet, as the Company has an unconditional right to payment as of the end of the applicable period. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price. Costs associated with product sales, which include commissions and royalties, are expensed when incurred because the expense is incurred at a point in time and the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of goods sold in the condensed statements of operations and comprehensive loss. The Company accepts product returns at its discretion or if the product is defective as manufactured. The Company establishes estimated provisions for returns based on historical experience and considers other factors that it believes could significantly impact its expected returns, which provisions are classified within accrued liabilities on the condensed balance sheet. The Company elected to expense shipping and handling costs as incurred and includes them in the cost of goods sold. In those cases where the Company bills shipping and handling costs to customers, it will classify the amounts billed as a component of revenue. |
Cost of Goods Sold | Cost of Goods Sold The Company manufactures certain of its portfolio of TCAR products at its California and Minnesota facilities and purchases other products from third party manufacturers. Cost of goods sold consists primarily of costs related to materials, components and sub-assemblies, manufacturing overhead costs, direct labor, scrap, product rework, reserves for excess, obsolete and non-sellable inventories as well as logistics-related expenses. A significant portion of the Company’s cost of goods sold currently consists of manufacturing overhead costs. These overhead costs include the cost of quality control, material procurement, inventory control, facilities, equipment and operations supervision and management. Cost of goods sold also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalties. |
Stock-Based Compensation | Stock–Based Compensation The Company accounts for stock-based compensation in accordance with Financial Accounting Standards Board, or FASB, ASC 718, "Compensation-Stock Compensation." ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options, restricted stock units, performance stock units, and shares issued under its employee stock purchase plan. ASC 718 requires companies to estimate the fair value of all share-based payment option awards on the date of grant using an option pricing model. The fair value of stock options is recognized over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period (usually the vesting period), on a straight-line basis. The Company accounts for option forfeitures as they occur. The Company accounts for stock-based compensation for restricted stock units at their fair value, based on the closing market price of the Company’s common stock on the date of grant. These costs are recognized on a straight-line basis over the requisite service period, which is usually the vesting period. The Company accounts for stock-based compensation for performance stock units with market-based conditions at their fair value on the date of the award using the Monte Carlo simulation model. These costs are recognized over the requisite service period, which is usually the vesting period, regardless of the likelihood of achievement of the market-based performance criteria. The Company accounts for stock-based compensation for its employee stock purchase plan based on the estimated fair value on the first day of the offering period using an option pricing model for each purchase period. These costs are recognized on a straight-line basis over the offering period. |
Income Taxes | Income Taxes The Company accounts for income taxes under the liability method, whereby deferred tax assets and liabilities are determined based on the difference between the condensed financial statements and tax bases of assets and liabilities using the enacted tax rates in effect for the year in which the differences are expected to affect taxable income. A valuation allowance is established when necessary to reduce deferred tax assets to the amounts expected to be realized. As the Company has historically incurred operating losses, it has established a full valuation allowance against its net deferred tax assets, and there is no provision for income taxes. The Company also follows the provisions of ASC 740-10, "Accounting for Uncertainty in Income Taxes." ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or expected to be taken on a tax return. No liability related to uncertain tax positions is recorded on the condensed financial statements. It is the Company's policy to include penalties and interest expense related to income taxes as part of the provision for income taxes. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss consists of net loss and changes in unrealized gains and losses on investments classified as available-for-sale. For the three months ended March 31, 2024 and 2023 , the Company’s unrealized gains and losses on available-for-sale investments represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the condensed statements of operations and comprehensive loss. Accumulated other comprehensive income (loss) is presented in the accompanying condensed balance sheets as a component of stockholders' equity. |
Net Loss per Share | Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potential dilutive common shares. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock options, restricted stock units and performance stock units are considered to be potentially dilutive securities. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive. Net loss per share was determined as follows (in thousands, except share and per share data): Three Months Ended March 31, 2024 2023 Net loss $ ( 14,136 ) $ ( 16,460 ) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 39,261,496 38,532,202 Net loss per share, basic and diluted $ ( 0.36 ) $ ( 0.43 ) The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an antidilutive impact due to the Company's net loss: March 31, 2024 2023 Common stock options 3,617,465 3,689,853 Restricted stock units and performance stock units 4,512,326 1,692,645 Total 8,129,791 5,382,498 |
Segment and Geographical Information | Segment and Geographical Information The Company operates and manages its business as one reportable and operating segment. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. Primarily all of the Company’s long-lived assets are based in the United States. Long-lived assets are comprised of property and equipment. All of the Company’s revenue was in the United States for the three months ended March 31, 2024 and 2023, based on the shipping location of the external customer. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Schedule of Net Loss Per Share Determination | Three Months Ended March 31, 2024 2023 Net loss $ ( 14,136 ) $ ( 16,460 ) Weighted average common stock outstanding used to compute net loss per share, basic and diluted 39,261,496 38,532,202 Net loss per share, basic and diluted $ ( 0.36 ) $ ( 0.43 ) |
Schedule of Potentially Dilutive Securities Outstanding Excluded from Diluted Weighted Average Shares Outstanding | March 31, 2024 2023 Common stock options 3,617,465 3,689,853 Restricted stock units and performance stock units 4,512,326 1,692,645 Total 8,129,791 5,382,498 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements [Abstract] | |
Financial Assets Measured on a Recurring Basis | March 31, 2024 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 22,355 $ — $ — $ 22,355 U.S. treasury bills 8,911 — — 8,911 Commercial paper — 12,568 — 12,568 Corporate bonds/notes — 28,522 — 28,522 U.S. government securities — 56,970 — 56,970 Agency bonds/notes — 46,889 — 46,889 Total $ 31,266 $ 144,949 $ — $ 176,215 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 19,483 $ — $ — $ 19,483 U.S. treasury bills 11,899 — — 11,899 Commercial paper — 33,150 — 33,150 Corporate bonds/notes — 39,438 — 39,438 U.S. government securities — 17,556 — 17,556 Agency bonds/notes — 68,677 — 68,677 Total $ 31,382 $ 158,821 $ — $ 190,203 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Components [Abstract] | |
Fair Value of the Available-For-Sale Investments | March 31, 2024 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 22,355 $ — $ — $ 22,355 U.S. treasury bills 8,914 — ( 3 ) 8,911 Commercial paper 12,573 — ( 5 ) 12,568 Corporate bonds/notes 28,505 19 ( 2 ) 28,522 U.S. government securities 56,983 10 ( 23 ) 56,970 Agency bonds/notes 46,903 4 ( 18 ) 46,889 Total $ 176,233 $ 33 $ ( 51 ) $ 176,215 Classified as: Cash equivalents $ 22,355 Short-term investments 151,833 Long-term investments 2,027 Total $ 176,215 December 31, 2023 Gross Unrealized Estimated Amortized Cost Gains Losses Fair Value Money market funds $ 19,483 $ — $ — $ 19,483 U.S. treasury bills 11,896 3 — 11,899 Commercial paper 33,160 5 ( 15 ) 33,150 Corporate bonds/notes 39,398 55 ( 15 ) 39,438 U.S. government securities 17,501 55 — 17,556 Agency bonds/notes 68,693 27 ( 43 ) 68,677 Total $ 190,131 $ 145 $ ( 73 ) $ 190,203 Classified as: Cash equivalents $ 19,483 Short-term investments 161,264 Long-term investments 9,456 Total $ 190,203 |
Fair Value of Cash Equivalents, Short-Term and Long-Term Equivalents | March 31, December 31, 2024 2023 Amounts maturing within one year $ 174,188 $ 180,747 Amounts maturing after one year through two years 2,027 9,456 Total $ 176,215 $ 190,203 |
Available-For-Sale Investments in Unrealized Loss Position | March 31, 2024 December 31, 2023 Less than 12 months Less than 12 months Assets: Fair Value Unrealized Loss Fair Value Unrealized Loss U.S. treasury bills $ 4,913 $ ( 3 ) $ — $ — Commercial paper 12,568 ( 5 ) 19,684 ( 15 ) Corporate bonds/notes 8,985 ( 2 ) 21,842 ( 15 ) U.S. government securities 34,194 ( 23 ) — — Agency bonds/notes 28,271 ( 18 ) 48,964 ( 43 ) Total $ 88,931 $ ( 51 ) $ 90,490 $ ( 73 ) |
Schedule of Inventories | March 31, December 31, 2024 2023 Raw materials $ 5,993 $ 6,512 Finished products 24,493 23,364 Total inventories $ 30,486 $ 29,876 |
Schedule of Accrued Liabilities | March 31, December 31, 2024 2023 Accrued payroll and related expenses $ 11,855 $ 17,113 Operating lease liability 1,701 1,703 Accrued travel expenses 1,109 944 Provision for sales returns 589 500 Accrued interest payable 517 517 Accrued royalty expense 428 405 Accrued administration fees and sales rebates 414 405 Accrued professional services 411 326 Accrued clinical expenses 339 256 Deferred revenue 317 143 Accrued other expenses 691 2,295 Total accrued liabilities $ 18,371 $ 24,607 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Long-term Debt [Abstract] | |
Future Payment Under the Term Loan | Period Ending December 31: Amount 2024 $ 4,297 2025 5,703 2026 45,699 2027 34,518 90,217 Add: Accretion of closing fees 1,530 91,747 Less: Amount representing interest ( 15,216 ) Less: Amount representing debt discount and debt issuance costs ( 645 ) Present value of minimum payments $ 75,886 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies [Abstract] | |
Balance Sheet Information | March 31, December 31, Operating Lease: 2024 2023 Operating lease right-of-use assets in other non-current assets $ 6,208 $ 6,489 Operating lease liabilities in accrued liabilities $ 1,701 $ 1,703 Operating lease liabilities in other liabilities 6,968 7,304 Total operating lease liabilities $ 8,669 $ 9,007 |
Operating Lease Maturities | Period Ending December 31: Amount 2024 $ 1,492 2025 2,130 2026 2,255 2027 2,068 2028 and thereafter 2,391 Total lease payments $ 10,336 Less: imputed interest ( 1,667 ) Present value of lease liabilities $ 8,669 |
Stock-Based Compensation Plans
Stock-Based Compensation Plans (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Shares Available for Issuance | Number of Shares Balances, December 31, 2023 532,627 Authorized 1,566,619 Allowance for PSU for overperformance ( 111,641 ) Granted / Awarded ( 1,282,295 ) Cancelled 50,232 Balances, March 31, 2024 755,542 |
Summary of Stock Option Activity | Options Outstanding Number of Weighted Average Weighted Average Remaining Contractual Term Aggregate Intrinsic Shares Exercise Price (Years) Value Balances, December 31, 2023 3,632,684 $ 25.02 5.52 $ 7,942,439 Options granted — $ — Options exercised — $ — Options cancelled ( 15,219 ) $ 41.43 Balances, March 31, 2024 3,617,465 $ 24.95 5.24 $ 16,441,732 Vested and exercisable at March 31, 2024 3,268,983 $ 23.10 4.97 $ 16,441,732 Vested and expected to vest at March 31, 2024 3,617,465 $ 24.95 5.24 $ 16,441,732 |
Summary of Stock-Based Compensation | Three Months Ended March 31, 2024 2023 Cost of goods sold $ 439 $ 390 Research and development expenses 2,119 1,632 Selling, general and administrative expenses 7,801 6,816 Total stock-based compensation expense $ 10,359 $ 8,838 |
Restricted Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Stock Unit Activity | Number of Restricted Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2023 2,726,972 $ 26.02 Awards granted 1,170,654 $ 17.14 Awards vested ( 271,153 ) $ 42.52 Awards canceled ( 35,013 ) $ 38.06 Balances, March 31, 2024 3,591,460 $ 21.76 Expected to vest at March 31, 2024 3,591,460 $ 21.76 |
Performance Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Stock Unit Activity | Number of Performance Stock Units Weighted Average Grant Date Fair Value Balances, December 31, 2023 809,225 $ 27.86 Awards granted 111,641 $ 28.71 Awards vested — $ — Awards canceled — $ — Balances, March 31, 2024 920,866 $ 27.96 Expected to vest at March 31, 2024 920,866 $ 27.96 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) | 3 Months Ended | ||
Mar. 31, 2024 USD ($) segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Summary of Significant Accounting Policies [Abstract] | |||
Available-for-sale securities, credit losses | $ 0 | $ 0 | |
Unbilled receivables | 379,000 | $ 227,000 | |
Provision for income taxes | 0 | ||
Liability for uncertain tax positions | $ 0 | ||
Number of reportable segments | segment | 1 | ||
Number of operating segments | segment | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Schedule of Net Loss Per Share Determination) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Summary of Significant Accounting Policies [Abstract] | ||
Net loss | $ (14,136) | $ (16,460) |
Weighted average common stock outstanding used to compute net loss per share, basic (in shares) | 39,261,496 | 38,532,202 |
Weighted average common stock outstanding used to compute net loss per share, diluted (in shares) | 39,261,496 | 38,532,202 |
Net loss per share, basic | $ (0.36) | $ (0.43) |
Net loss per share, diluted | $ (0.36) | $ (0.43) |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Schedule of Potentially Dilutive Securities Not Included in Calculation of Earnings per Share) (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 8,129,791 | 5,382,498 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 3,617,465 | 3,689,853 |
Restricted Stock Units and Performance Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,512,326 | 1,692,645 |
Fair Value Measurements (Financ
Fair Value Measurements (Financial Assets Measured on a Recurring Basis) (Details) - Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | $ 176,215 | $ 190,203 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 22,355 | 19,483 |
US Treasury Bills [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 8,911 | 11,899 |
Commercial Papers [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 12,568 | 33,150 |
Corporate Bonds/Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 28,522 | 39,438 |
U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 56,970 | 17,556 |
Agency bonds/notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 46,889 | 68,677 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 31,266 | 31,382 |
Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 22,355 | 19,483 |
Level 1 [Member] | US Treasury Bills [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 8,911 | 11,899 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 144,949 | 158,821 |
Level 2 [Member] | Commercial Papers [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 12,568 | 33,150 |
Level 2 [Member] | Corporate Bonds/Notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 28,522 | 39,438 |
Level 2 [Member] | U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 56,970 | 17,556 |
Level 2 [Member] | Agency bonds/notes [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | $ 46,889 | $ 68,677 |
Balance Sheet Components (Narra
Balance Sheet Components (Narrative) (Details) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Components [Abstract] | ||
Weighted average days to maturity | 146 days | |
Work-in-process inventories | $ 0 | $ 0 |
Debt Securities, Available-for-Sale, Unrealized Loss Position | $ 0 | $ 0 |
Balance Sheet Components (Fair
Balance Sheet Components (Fair Value of Available-For-Sale Investments) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 176,233 | $ 190,131 |
Gross Unrealized Gains | 33 | 145 |
Gross Unrealized Losses | (51) | (73) |
Estimated Fair Value | 176,215 | 190,203 |
Cash equivalents | 22,355 | 19,483 |
Short-term investments | 151,833 | 161,264 |
Long-term Investments | 2,027 | 9,456 |
Total | 176,215 | 190,203 |
Money Market Funds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 22,355 | 19,483 |
Estimated Fair Value | 22,355 | 19,483 |
US Treasury Bills [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 8,914 | 11,896 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | (3) | |
Estimated Fair Value | 8,911 | 11,899 |
Commercial Paper [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 12,573 | 33,160 |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | (5) | (15) |
Estimated Fair Value | 12,568 | 33,150 |
Corporate Bonds/Notes [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 28,505 | 39,398 |
Gross Unrealized Gains | 19 | 55 |
Gross Unrealized Losses | (2) | (15) |
Estimated Fair Value | 28,522 | 39,438 |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 56,983 | 17,501 |
Gross Unrealized Gains | 10 | 55 |
Gross Unrealized Losses | (23) | |
Estimated Fair Value | 56,970 | 17,556 |
Agency bonds/notes [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 46,903 | 68,693 |
Gross Unrealized Gains | 4 | 27 |
Gross Unrealized Losses | (18) | (43) |
Estimated Fair Value | $ 46,889 | $ 68,677 |
Balance Sheet Components (Fai_2
Balance Sheet Components (Fair Value of Cash Equivalents, Short-Term and Long-Term Investments) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Components [Abstract] | ||
Amounts maturing within one year | $ 174,188 | $ 180,747 |
Amounts maturing after one year through two years | 2,027 | 9,456 |
Total | $ 176,215 | $ 190,203 |
Balance Sheet Components (Avail
Balance Sheet Components (Available-for-Sale Investments in Unrealized Loss Position) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | $ 88,931 | $ 90,490 |
Unrealized Loss, Less than 12 months | (51) | (73) |
US Treasury Bills [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | 4,913 | |
Unrealized Loss, Less than 12 months | (3) | |
Commercial Paper [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | 12,568 | 19,684 |
Unrealized Loss, Less than 12 months | (5) | (15) |
Corporate Bonds/Notes [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | 8,985 | 21,842 |
Unrealized Loss, Less than 12 months | (2) | (15) |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | 34,194 | |
Unrealized Loss, Less than 12 months | (23) | |
Agency bonds/notes [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value, Less than 12 months | 28,271 | 48,964 |
Unrealized Loss, Less than 12 months | $ (18) | $ (43) |
Balance Sheet Components (Sched
Balance Sheet Components (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Components [Abstract] | ||
Raw materials | $ 5,993 | $ 6,512 |
Finished products | 24,493 | 23,364 |
Total inventories | $ 30,486 | $ 29,876 |
Balance Sheet Components (Accru
Balance Sheet Components (Accrued Liabilities) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Components [Abstract] | ||
Accrued payroll and related expenses | $ 11,855 | $ 17,113 |
Operating lease liability | 1,701 | 1,703 |
Accrued travel expenses | 1,109 | 944 |
Provision for sales returns | 589 | 500 |
Accrued interest payable | 517 | 517 |
Accrued royalty expense | 428 | 405 |
Accrued administration fees and sales rebates | 414 | 405 |
Accrued professional services | 411 | 326 |
Accrued clinical expenses | 339 | 256 |
Deferred revenue | 317 | 143 |
Accrued other expenses | 691 | 2,295 |
Total accrued liabilities | $ 18,371 | $ 24,607 |
Long-term Debt (Narrative) (Det
Long-term Debt (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
May 31, 2022 | Mar. 31, 2024 | May 27, 2022 | |
Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Debt. Default, Rate Increase | 5% | ||
Secured Debt [Member] | Stifel Bank [Member] | |||
Subsequent Event [Line Items] | |||
Facility amount | $ 200,000,000 | ||
Term Loan [Member] | |||
Subsequent Event [Line Items] | |||
Percentage of revenue for debt repayment | 90% | ||
Term Loan [Member] | Stifel Bank [Member] | |||
Subsequent Event [Line Items] | |||
Repayment of outstanding loan amount | 49,181,000 | ||
Debt interest | 181,000 | ||
Loss on debt extinguishment | $ 245,000 | ||
Term Loan [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Percentage of prepayment fees | 3% | ||
Percentage of prepayment fees in second year | 2% | ||
Percentage of prepayment fees in third year | 1% | ||
Percent aggregate original principal amount | 5% | ||
Term loan prepaid in increments | $ 10,000,000 | ||
Loan Facility [Member] | Stifel Bank [Member] | |||
Subsequent Event [Line Items] | |||
Facility fee | $ 367,500 | ||
Debt Instrument, Fee Amount | $ 367,500 | ||
Letter of Credit [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Aggregate outstanding principal balance | $ 75,000,000 | ||
Annual interest rate | 7.50% | ||
Secured Revolving Credit Facility [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Annual interest rate | 2.50% | ||
Maturity date | May 01, 2027 | ||
Percent of borrowing base of eligible receivables | 85% | ||
Percent of eligible inventory | 50% | ||
Percent of borrowing base in case eligible inventory | 40% | ||
Borrowing base amount in case eligible inventory | $ 10,000,000 | ||
Debt instrument margin rate | 5% | ||
Secured Revolving Credit Facility [Member] | Index Rate [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Variable interest rate | 0.85% | 0.85% | |
Debt instrument margin rate | 3% | ||
Secured Revolving Credit Facility [Member] | Secured Debt [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Facility amount | $ 25,000,000 | ||
Secured Revolving Credit Facility [Member] | Term Loan [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Facility amount | 25,000,000 | $ 50,000,000 | |
Loan Agreement [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Facility amount | $ 225,000,000 | ||
Loan Agreement [Member] | Term Loan [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Percentage of revenue for debt repayment | 75% | ||
Percent aggregate original principal amount | 50% | ||
Term Loan, First Tranche [Member] | Term Loan [Member] | |||
Subsequent Event [Line Items] | |||
Debt, face amount | $ 75,000,000 | ||
Term Loan, Second Tranche [Member] | Term Loan [Member] | |||
Subsequent Event [Line Items] | |||
Debt, face amount | 75,000,000 | ||
Term Loan, Third Tranche [Member] | Term Loan [Member] | |||
Subsequent Event [Line Items] | |||
Debt, face amount | $ 50,000,000 | ||
Maximum [Member] | Secured Term Loan Facility [Member] | Oxford Finance [Member] | |||
Subsequent Event [Line Items] | |||
Percent aggregate original principal amount | 6.75% |
Long-term Debt (Future Payment
Long-term Debt (Future Payment Under the Term Loan) (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Long-term Debt [Abstract] | |
2024 | $ 4,297 |
2025 | 5,703 |
2026 | 45,699 |
2027 | 34,518 |
Long-term debt, gross before accretion of closing fees | 90,217 |
Add: Accretion of closing fees | 1,530 |
Long-Term Debt, Gross, After Accretion Of Closing Fees | 91,747 |
Less: Amount representing interest | (15,216) |
Less: Amount representing debt discount and debt issuance costs | (645) |
Present value of minimum payments | $ 75,886 |
Commitments and Contingencies_2
Commitments and Contingencies (Narrative) (Details) - USD ($) | 1 Months Ended | ||
May 31, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Lessee, Lease, Description [Line Items] | |||
Purchase obligation | $ 27,032,000 | ||
Indemnification obligations, liability recognized | 0 | ||
Contingent liabilities requiring accrual | $ 0 | $ 0 | |
Additional extended lease period | 3 years | ||
Right-of-use asset obtained in exchange for lease obligation | $ 2,504,000 | ||
Headquarters [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Renewal term | 5 years | ||
Additional Office, Laboratory And Manufacturing Space [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Renewal term | 5 years |
Commitments and Contingencies_3
Commitments and Contingencies (Balance Sheet Information) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Commitments and Contingencies [Abstract] | ||
Operating lease right-of-use assets in other non-current assets | $ 6,208 | $ 6,489 |
Operating lease liabilities in accrued liabilities | 1,701 | 1,703 |
Operating lease liabilities in other liabilities | 6,968 | 7,304 |
Total operating lease liabilities | $ 8,669 | $ 9,007 |
Commitments and Contingencies_4
Commitments and Contingencies (Operating Lease Maturities) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Commitments and Contingencies [Abstract] | ||
2024 | $ 1,492 | |
2025 | 2,130 | |
2026 | 2,255 | |
2027 | 2,068 | |
2028 and thereafter | 2,391 | |
Total lease payments | 10,336 | |
Less: imputed interest | (1,667) | |
Present value of lease liabilities | $ 8,669 | $ 9,007 |
Stock-Based Compensation Plan_2
Stock-Based Compensation Plans (Narrative) (Details) $ in Thousands | 1 Months Ended | 3 Months Ended |
Mar. 31, 2024 USD ($) shares | Mar. 31, 2024 USD ($) shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Compensation expensed not yet recognized | $ | $ 4,267 | $ 4,267 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Performance | 100% | |
2019 ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Compensation expensed not yet recognized, period for recognition | 1 month 17 days | |
Common Stock Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate intrinsic value of options exercised | $ | $ 0 | |
Compensation expensed not yet recognized, period for recognition | 1 year 6 months 18 days | |
Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting term | 2 years 10 months 13 days | |
Unrecognized compensation costs of unvested RSUs | $ | $ 86,470 | $ 86,470 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 1,170,654 | |
Performance Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting term | 3 years | 3 years |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 111,641 | 111,641 |
Expected volatility | 72.70% | |
Risk-free interest rate | 4.27% | |
Dividend yield | 0% | |
Performance Stock Units [Member] | Benchmark [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 57.60% | |
Risk-free interest rate | 0.35% | |
2019 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock reserved for issuance (in shares) | 9,518,753 | 9,518,753 |
Unrecognized compensation costs related to the ESPP | $ | $ 236 | $ 236 |
2019 Equity Incentive Plan [Member] | Common Stock Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Issuance of common stock under employee stock purchase plan (in shares) | 465,952 | |
Shares available for future issuance (in shares) | 1,748,117 | 1,748,117 |
2019 Equity Incentive Plan [Member] | Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting term | 4 years | |
2019 Equity Incentive Plan [Member] | Maximum [Member] | Performance Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Performance | 200% |
Stock-Based Compensation Plan_3
Stock-Based Compensation Plans (Summary of Shares Available for Issuance) (Details) - 2019 Equity Incentive Plan [Member] | 3 Months Ended |
Mar. 31, 2024 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Beginning balance (in shares) | 532,627 |
Authorized (in shares) | 1,566,619 |
Allowance for Performance Stock Units for overperformance (in shares) | (111,641) |
Granted/Awarded (in shares) | (1,282,295) |
Canceled (in shares) | 50,232 |
Ending balance (in shares) | 755,542 |
Stock-Based Compensation Plan_4
Stock-Based Compensation Plans (Summary of Stock Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Beginning balance (in shares) | 3,632,684 | |
Options cancelled (in shares) | (15,219) | |
Ending balance (in shares) | 3,617,465 | 3,632,684 |
Vested and exercisable (in shares) | 3,268,983 | |
Vested and expect to vest (in shares) | 3,617,465 | |
Weighted Average Exercise Price | ||
Beginning balance (in USD per share) | $ 25.02 | |
Options cancelled (in USD per share) | 41.43 | |
Ending balance (in USD per share) | 24.95 | $ 25.02 |
Vested and exercisable (in USD per share) | 23.10 | |
Vested and expected to vest (in USD per share) | $ 24.95 | |
Weighted Average Remaining Contractual Term (in Years) | ||
Awards outstanding | 5 years 2 months 26 days | 5 years 6 months 7 days |
Vested and exercisable | 4 years 11 months 19 days | |
Vested and expected to vest | 5 years 2 months 26 days | |
Aggregate Intrinsic Value (in thousands) | ||
Awards outstanding | $ 16,441,732 | $ 7,942,439 |
Vested and exercisable | 16,441,732 | |
Vested and expected to vest | $ 16,441,732 |
Stock-Based Compensation Plan_5
Stock-Based Compensation Plans (Summary of Stock Unit Activity) (Details) | 1 Months Ended | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | Mar. 31, 2024 $ / shares shares | |
Restricted Stock Units [Member] | ||
Number of Stock Units | ||
Beginning balance (in shares) | shares | 2,726,972 | |
Awards granted (in shares) | shares | 1,170,654 | |
Awards vested (in shares) | shares | (271,153) | |
Awards cancelled (in shares) | shares | (35,013) | |
Ending balance (in shares) | shares | 3,591,460 | 3,591,460 |
Expected to vest (in shares) | shares | 3,591,460 | 3,591,460 |
Weighted Average Grant Date Fair Value | ||
Beginning balance (in USD per share) | $ / shares | $ 26.02 | |
Awards granted (in USD per share) | $ / shares | 17.14 | |
Awards vested (in USD per share) | $ / shares | 42.52 | |
Awards cancelled (in USD per share) | $ / shares | 38.06 | |
Ending balance (in USD per share) | $ / shares | $ 21.76 | 21.76 |
Expected to vest (in USD per share) | $ / shares | $ 21.76 | $ 21.76 |
Performance Stock Units [Member] | ||
Number of Stock Units | ||
Beginning balance (in shares) | shares | 809,225 | |
Awards granted (in shares) | shares | 111,641 | 111,641 |
Ending balance (in shares) | shares | 920,866 | 920,866 |
Expected to vest (in shares) | shares | 920,866 | 920,866 |
Weighted Average Grant Date Fair Value | ||
Beginning balance (in USD per share) | $ / shares | $ 27.86 | |
Awards granted (in USD per share) | $ / shares | 28.71 | |
Ending balance (in USD per share) | $ / shares | $ 27.96 | 27.96 |
Expected to vest (in USD per share) | $ / shares | $ 27.96 | $ 27.96 |
Stock-Based Compensation Plan_6
Stock-Based Compensation Plans (Summary of Stock-Based Compensation) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 10,359 | $ 8,838 |
Cost of Goods Sold [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 439 | 390 |
Research and Development Expenses [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 2,119 | 1,632 |
Selling, General and Administrative Expenses [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 7,801 | $ 6,816 |
401(k) Plan (Details)
401(k) Plan (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
401(k) Plan [Abstract] | ||
Percentage employee contribution | 90% | |
Employer discretionary contribution | $ 778 | $ 683 |
Employer contribution match percentage | 50% | |
Percent of matching contribution of the employee's pay | 6% |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |