Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Statement of Financial Position [Abstract] | ||
| Accounts receivable, allowances (in dollars) | $ 2,776 | $ 3,132 |
| Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
| Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
| Preferred stock, shares issued | 0 | 0 |
| Preferred stock, shares outstanding | 0 | 0 |
| Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
| Common stock, shares authorized | 200,000,000 | 200,000,000 |
| Common stock, shares issued | 11,375,478 | 10,709,716 |
| Common stock, shares outstanding | 11,368,205 | 10,702,444 |
| Treasury stock, shares | 7,273 | 7,273 |
Condensed Consolidated Statements of Operations - USD ($) |
3 Months Ended | 9 Months Ended | ||
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Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
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| Income Statement [Abstract] | ||||
| Net sales | $ 19,544,000 | $ 22,570,000 | $ 65,231,000 | $ 65,481,000 |
| Cost of goods sold | 9,515,000 | 9,794,000 | 30,440,000 | 27,118,000 |
| Gross profit | 10,029,000 | 12,776,000 | 34,791,000 | 38,363,000 |
| Operating expenses: | ||||
| Sales and marketing | 9,330,000 | 12,290,000 | 29,487,000 | 41,542,000 |
| Research and development | 2,476,000 | 3,720,000 | 7,571,000 | 9,823,000 |
| General and administrative | 7,620,000 | 9,324,000 | 24,805,000 | 31,589,000 |
| Total operating expenses | 19,426,000 | 25,334,000 | 61,863,000 | 82,954,000 |
| Loss from operations | (9,397,000) | (12,558,000) | (27,072,000) | (44,591,000) |
| Other (expense) income, net: | ||||
| Interest income | 168,000 | 41,000 | 458,000 | 58,000 |
| Interest expense | (2,367,000) | (2,364,000) | (7,250,000) | (6,584,000) |
| Change in fair value of derivative liability | (3,153,000) | 0 | (3,153,000) | 0 |
| Other (expense) income, net | (24,000) | (6,000) | (125,000) | (1,000) |
| Total other (expense) income, net | (5,376,000) | (2,329,000) | (10,070,000) | (6,527,000) |
| Loss from continuing operations before income taxes | (14,773,000) | (14,887,000) | (37,142,000) | (51,118,000) |
| Income tax expense | 0 | 0 | 0 | 0 |
| Loss from continuing operations | (14,773,000) | (14,887,000) | (37,142,000) | (51,118,000) |
| Loss from discontinued operations, net of income taxes | 0 | (94,000) | 0 | (208,000) |
| Net loss | $ (14,773,000) | $ (14,981,000) | $ (37,142,000) | $ (51,326,000) |
| Basic net loss per common share | ||||
| Continuing operations | $ (1.31) | $ (2.37) | $ (3.23) | $ (8.16) |
| Discontinued operations | 0 | (0.01) | 0 | (0.03) |
| Basic net loss per share | (1.31) | (2.38) | (3.23) | (8.19) |
| Diluted net loss per common share | ||||
| Continuing operations | (1.31) | (2.37) | (3.23) | (8.16) |
| Discontinued operations | 0 | (0.01) | 0 | (0.03) |
| Diluted net loss per share | $ (1.31) | $ (2.38) | $ (3.23) | $ (8.19) |
| Weighted average outstanding common shares used for net loss per common share: | ||||
| Basic | 11,290,699 | 6,284,817 | 11,488,310 | 6,261,350 |
| Diluted | 11,290,699 | 6,284,817 | 11,488,310 | 6,261,350 |
Summary of Significant Accounting Policies |
9 Months Ended |
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Sep. 30, 2023 | |
| Accounting Policies [Abstract] | |
| Summary of Significant Accounting Policies | 1. Summary of Significant Accounting Policies a. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of Sientra, Inc. (“Sientra”, the “Company”, “we”, “our”, or “us”) in this Quarterly Report on Form 10-Q have been prepared in accordance with U.S. generally accepted accounting principles, or "GAAP", and the rules and regulations of the U.S. Securities and Exchange Commission, or the "SEC". Accordingly, they do not include certain notes and financial presentations normally required under GAAP for complete financial reporting. The interim financial information is unaudited, but reflects all normal adjustments and accruals which are, in the opinion of management, considered necessary to provide a fair presentation for the interim periods presented. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on April 18, 2023, or the Annual Report. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period.
Reverse Stock Split
On January 19, 2023, the Company effected a 1-for-10 reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding common stock, par value $0.01 per share (the “Common Stock”) by the filing of a Certificate of Amendment (the “Certificate”) with the Secretary of State of the State of Delaware pursuant to the Delaware General Corporation Law. The Reverse Stock Split became effective on January 19, 2023.
As a result of the Reverse Stock Split, every 10 shares of Common Stock issued and outstanding were automatically reclassified into one new share of common stock. The Reverse Stock Split did not modify any rights or preferences of the shares of Common Stock. Proportionate adjustments were made to the exercise or conversion prices and the number of shares underlying the Company’s outstanding equity awards, convertible securities and warrants, as well as to the number of shares issued and issuable under the Company’s equity incentive plans. The Common Stock issued pursuant to the Reverse Stock Split remained fully paid and non-assessable. The Reverse Stock Split did not affect the number of authorized shares of Common Stock or the par value of the Common Stock. All share information in the accompanying financial statements has been adjusted to reflect the results of the Reverse Stock Split.
Discontinued Operations of miraDry As a result of the miraDry sale discussed in Note 2, the miraDry business met the criteria to be reported as discontinued operations. Therefore, the Company is reporting the historical results of miraDry, including the results of operations, cash flows, and related assets and liabilities, as discontinued operations for all periods presented herein through the date of the Sale. Unless otherwise noted, the accompanying notes to the unaudited condensed consolidated financial statements have all been revised to reflect continuing operations only. Following the sale the Company has one operating segment in continuing operations named Plastic Surgery, formerly known as Breast Products.
b. Liquidity and Going Concern
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared assuming the Company will continue as a going concern and in accordance with GAAP. The going concern basis of presentation assumes that the Company will continue in operation one year after the date these financial statements are issued and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.
Pursuant to the requirements of the Financial Accounting Standards Board’s Accounting Standards Codification (“ASC”) Topic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date these condensed consolidated financial statements are issued. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the condensed consolidated financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.
Recurring Operating Losses
Since the Company’s inception, it has incurred recurring losses and cash outflows from operations and the Company anticipates that losses will continue in the near term. During the nine months ended September 30, 2023, the Company incurred net losses of $37.1 million and used $10.2 million of cash in operating activities. As of September 30, 2023, the Company had cash and cash equivalents of $15.0 million. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern for a period of at least one year from the date of issuance of these unaudited condensed consolidated financial statements. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
To alleviate these conditions, management is currently evaluating various cost-saving measures to reduce operating expenses and cash outflows. However, the Company will need to generate a significant increase in net sales to further improve profitability and cash inflows, which is dependent upon continued growth in our Plastic Surgery segment and the launch of new products and partnerships. Additionally, we are evaluating various funding alternatives to improve liquidity and may seek to raise additional equity or debt capital, refinance our debt obligations or obtain waivers, and/or scale back or freeze our organic growth plans to manage our liquidity and capital resources. As the Company seeks additional sources of financing, there can be no assurance that such financing would be available to the Company on favorable terms or at all. The Company’s ability to obtain additional financing in the equity capital markets is subject to several factors, including market and economic conditions, the Company’s performance and investor sentiment with respect to the Company and its industry.
During 2022, to fund ongoing operating and capital needs, the Company raised additional capital through the sale of equity securities and incremental debt financing. See Note 7 to the condensed consolidated financial statements for further details.
Financial Covenants
The Company was not in compliance with its financial covenants related to minimum revenue under the Amended and Restated Facility Agreement (“Restated Agreement”) with Deerfield at September 30, 2023. Under the terms of the Restated Agreement, the breach of the minimum revenue financial covenant is deemed an event of default. Under the Restated Agreement, in the event of default, Deerfield may elect that Default Interest of 2.0% shall be payable in cash on demand in addition to the applicable interest rate then in effect. Without a waiver or other relief under the Restated Agreement, one of the remedies that Deerfield has available to it, amongst others, is the ability to accelerate repayment of the debt, which the Company would not be able to immediately repay. The potential acceleration of the debt by Deerfield resulted in the reclassification of debt from a long-term liability to a current liability as of September 30, 2023.
On October 30, 2023, the Company entered into a Temporary Waiver and Exchange Agreement (the "Temporary Waiver and Exchange Agreement”) with Deerfield, which provides for a temporary waiver of the event of default through January 15, 2024. For further details, see Note 12 Subsequent Events.
c. Recent Accounting Pronouncements
Recently Adopted Accounting Standards
In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. The amendment eliminates certain accounting models and simplifies the accounting for convertible instruments and enhances disclosures for convertible instruments and earnings per share. The amendments are effective for public entities excluding smaller reporting companies for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023 including interim periods within those fiscal years and early adoption is permitted. The Company adopted this guidance effective January 1, 2023 under the modified retrospective adoption approach and there was no material impact on its consolidated financial statements from the adoption.
Recently Issued Accounting Standards
In December 2022, the FASB issued ASU 2022-06, Deferral of the Sunset Date of Topic 848 that extends the period of time preparers can utilize the reference rate reform relief guidance. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. To ensure the relief in Topic 848 covers the period of time during which a significant number of modifications may take place, the ASU defers the sunset date of Topic 848 from December 31, 2022, to December 31, 2024, after which entities will no longer be permitted to apply the relief in Topic 848. The Company is currently evaluating the impact the election of the optional expedient will have on the consolidated financial statements. d. Risks and Uncertainties
The COVID-19 pandemic continues to have a lingering effect on our business and results of operations, although to a lesser extent than in prior years. At the height of the pandemic and as an aesthetics company, the surgical procedures involving our breast products were susceptible to local and national government restrictions. The inability or limited ability to perform non-emergency procedures significantly harmed our revenues starting in the second quarter of 2020 and lasting through the first quarter of 2022. While restrictions on non-emergency procedures have been removed, there is still substantial uncertainty as to when, if at all, the aesthetic procedures that the Company’s products are sold into will return to pre-pandemic levels.
In addition, the global economy, including the financial and credit markets, has recently experienced extreme volatility and disruptions, including increases to inflation rates, rising interest rates, declines in consumer confidence, declines in economic growth, and uncertainty about economic stability. The severity and duration of the impact of these conditions on our business cannot be predicted.
The estimates used for, but not limited to, determining the collectability of accounts receivable, fair value of long-lived assets and goodwill, and sales returns liability required could be impacted by the factors described above. While the full impact and duration of the factors noted above is unknown at this time, the Company has made appropriate estimates based on the facts and circumstances available as of the reporting date. These estimates may change as new events occur and additional information is obtained. |
Discontinued Operations |
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| Discontinued Operations and Disposal Groups [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Discontinued Operations | 2. Discontinued Operations
On June 10, 2021, the Company completed the sale of its miraDry business (the “Sale”) to miraDry Acquisition Company, Inc., a Delaware corporation (“Buyer”), an entity affiliated with 1315 Capital II, LP, as a result of the Company’s strategic decision to focus investment on its core Plastic Surgery segment. The Sale was made pursuant to the terms and conditions of the Asset Purchase Agreement (the “Purchase Agreement”), dated May 11, 2021, among the Company and certain of its subsidiaries, Buyer, and, solely for purposes of Section 8.14 of the Purchase Agreement, 1315 Capital II, LP. The aggregate purchase price was $10.0 million, which after certain adjustments for agreed upon changes in the estimated net asset value amount of purchased assets and assumed liabilities resulted in net cash proceeds of $11.3 million to the Company on the date of close. In October 2021, the Company finalized the transaction and paid $3.2 million to the Buyer in accordance with the agreed upon post close changes in the net asset value and recognized a loss on sale of $2.5 million.
In accordance with the Purchase Agreement, assumed liabilities did not include product liabilities, environmental, and employee claims arising prior to the closing date. The Purchase Agreement also included customary representations and warranties, as well as certain covenants, including, among other things, that: (i) the Company will abide by certain non-solicitation, exclusivity, and non-competition covenants, and (ii) the Company would enter into a transition services agreement (“TSA”) to provide certain transition services related to the business.
Under the TSA, the Company provided certain post-closing services to the Buyer related to the miraDry business for a period of six months, including accounting, accounts receivable support, customer service, IT, regulatory, quality assurance, and clinical support. As consideration for these services, the Buyer reimbursed the Company for direct and certain indirect costs, as well as certain overhead or administrative expenses related to operating the business. The Company recognized $0.2 million of TSA fees and cost reimbursements in operating expenses from continuing operations in the condensed consolidated statement of operations for the nine months ended September 30, 2022. Since the closing date, the Company has received $0.3 million relating to the TSA services and has recorded a receivable of $0.1 million within other current assets in the condensed consolidated balance sheets. In connection with the accounts receivable support under the TSA, since the closing date the Company received $2.3 million in customer payments and has remitted $2.3 million to the Buyer. As of September 30, 2023, the Company does not have a payable to the Buyer on the condensed consolidated balance sheets.
Additionally, the Company and the Buyer entered into a sublease agreement whereby the Buyer subleased the miraDry office space in Santa Clara, CA. The sublease term was for an initial period of six months, with subsequent option periods for up to a total of twenty-four months. Following the initial period, the Buyer exercised an additional period of six months, and an extension of twelve months thereafter. The sublease expired in March 2023. During the three and nine months ended September 30, 2023, the Company recognized $0.0 million and $0.4 million, respectively of sublease income in general and administrative expenses in the condensed consolidated statements of operations. The Sale met the discontinued operations criteria given that the business is a component and represented a strategic shift. The following table presents the aggregate carrying amounts of major classes of assets and liabilities of discontinued operations (in thousands):
The results of operations for the miraDry business were included in loss from discontinued operations on the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2022. The following table provides information regarding the results of discontinued operations (in thousands):
The results of the miraDry business, including the results of operations, cashflows, and related assets and liabilities are reported in continuing operations for the three and nine months ended September 30, 2023. |
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Revenue |
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| Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Revenue | 3. Revenue The Company generates revenue primarily through the sale and delivery of promised goods or services to customers. Sales prices are documented in the executed sales contract, purchase order or order acknowledgement prior to the transfer of control to the customer. Typical payment terms are 30 days. Revenue contracts may include multiple products or services, each of which is considered a separate performance obligation. Performance obligations typically include the delivery of promised products, such as breast implants, tissue expanders, BIOCORNEUM, Viality, and SimpliDerm, along with service-type warranties. Other deliverables are sometimes promised but are ancillary and insignificant in the context of the contract as a whole. Revenue is allocated to each performance obligation based on its relative standalone selling price. The Company determines standalone selling prices based on observable prices for all performance obligations except for the service-type warranty under the Platinum20 Limited Warranty Program, or "Platinum20". The Company introduced Platinum20 in May 2018 on all breast implants implanted in the United States or Puerto Rico on or after May 1, 2018. Additionally, Platinum20 Program applies to all breast implants that are implanted in Canada on or after March 23, 2022. Platinum20 provides for financial assistance for revision surgeries and no-charge contralateral replacement implants upon the occurrence of certain qualifying events. The Company considers Platinum20 to have an assurance warranty component and a service warranty component. The assurance component is recorded as a warranty liability at the time of sale. The Company considers the service warranty component as an additional performance obligation and defers revenue at the time of sale using the expected cost plus a margin approach for the performance obligation. Inputs into the expected cost plus a margin approach include historical incidence rates, estimated replacement costs, estimated financial assistance payouts and an estimated margin. The liability for unsatisfied performance obligations under the service warranty as of September 30, 2023 was as follows (in thousands):
The liability for the short-term portion is included in “Accrued and other current liabilities” and the long-term portion is included in “Other liabilities” in the condensed consolidated balance sheets.
Revenue from service warranties are recognized ratably over the term of the agreement. Specifically for Platinum20, the performance obligations are satisfied at the time that the benefits are provided and are expected to be satisfied ratably over the 3 to 24 month period following sale of the product for financial assistance and 20 years for product replacement.
For delivery of promised products, control transfers and revenue is recognized upon shipment, unless the contractual arrangement requires transfer of control when products reach their destination, for which revenue is recognized once the product arrives at its destination. A portion of the Company’s revenue is generated from the sale of consigned inventory maintained at doctor, hospital, and clinic locations. For these products, revenue is recognized at the time the Company is notified by the customer that the product has been used, not when the consigned products are delivered to the customer’s location.
Sales Return Liability
With the exception of the Company’s BIOCORNEUM scar management products, Viality, inventory held on consignment, and products sold to international customers, the Company allows for the return of products from customers within six months after the original sale, which is accounted for as variable consideration. A sales return liability is established based on estimated returns using relevant historical experience taking into consideration recent gross sales and notifications of pending returns, as adjusted for changes in recent industry events and trends. Estimated future sales returns for the current and prior periods are recorded as a reduction of revenue and as a sales return liability in the current period. Actual sales returns for current and prior periods, in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the current or subsequent period would be recorded and noted separately as a change in estimate. The following table provides a rollforward of the sales return liability (in thousands):
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Fair Value of Financial Instruments |
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| Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value of Financial Instruments | 4. Fair Value of Financial Instruments
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, customer deposits and sales return liability are reasonable estimates of their fair value because of the short maturity of these items. The fair value of the contingent consideration related to past acquisitions, and the fair value attributable to the Convertible Note and 2022 Note (the "Convertible Notes") convertible features and contingent interest features are discussed in Note 5. As discussed in Note 5, the fair value of the Convertible Notes' conversion features was reclassified to equity in the current year and the contingent interest features that were not previously recorded by the Company has been measured at fair value for the period ended September 30, 2023. The Convertible Notes are carried at amortized cost on the condensed consolidated balance sheet.
The fair value of the debt is based on the amount of future cash flows associated with the instrument discounted using the Company’s market rate. As of September 30, 2023 and December 31, 2022, the carrying value and fair value of the Convertible Notes were as follows (in thousands):
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Balance Sheet Components |
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| Balance Sheet Related Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance Sheet Components | 5. Balance Sheet Components a. Inventories Inventories consist of the following (in thousands):
b. Property and Equipment, net Property and equipment, net consist of the following (in thousands):
Depreciation expense for the three months ended September 30, 2023 and 2022 was $0.9 million and $0.6 million, respectively. Depreciation expense for the nine months ended September 30, 2023 and 2022 was $2.8 million and $2.2 million, respectively. There were no impairments recorded during the nine months ended September 30, 2023 and 2022.
c. Goodwill and Other Intangible Assets, net Following the sale of the miraDry business, the Company has one reporting unit, Plastic Surgery, formerly known as Breast Products. The Company evaluates goodwill for impairment at least annually on October 1st and whenever circumstances suggest that goodwill may be impaired. The carrying amount of goodwill is $9.2 million for the years ended September 30, 2023 and December 31, 2022.
The components of the Company’s other intangible assets consist of the following (in thousands):
Amortization expense for the three months ended September 30, 2023 and 2022 was $1.0 and $0.9 million, respectively. Amortization expense for both the nine months ended September 30, 2023 and 2022 was $2.8 million. Amortization expense is recorded in general and administrative expense in the condensed consolidated statement of operations, with the exception of manufacturing know-how and developed technology, which is recorded in cost of goods sold. The following table summarizes the future estimated amortization expense relating to the Company's definite-lived intangible assets as of September 30, 2023 (in thousands):
d. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following (in thousands):
e. Warranty Reserve The following table provides a rollforward of the accrued assurance-type warranties (in thousands):
As of September 30, 2023 and 2022, the liability for the long-term balance is included in “Warranty reserve,” and the short-term portion is included in “Accrued and other current liabilities."
f. Liabilities measured at fair value Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 — Quoted prices in active markets for identical assets or liabilities. • Level 2 — Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. Contingent consideration The contingent consideration balance consists of milestone payments related to the acquisition of Viality and future royalty payments related to the acquisition of BIOCORNEUM. The Company assessed the fair value of all contingent consideration using a Monte-Carlo simulation model. The contingent consideration related to Viality is based on the achievement of certain clinical endpoints following the completion of a study measuring retention rates using the fat transfer products. The significant assumptions utilized in the fair value measurement was risk-free rate, the probable retention rate based on historical data and the Company's equity volatility of 95.0%. Any subsequent changes to the fair value of contingent consideration will be recorded as an adjustment to the carrying value of the assets acquired. The contingent consideration related to the acquisition of BIOCORNEUM consists of royalty obligations based on future net sales for a defined term, beginning in 2024. The significant assumption utilized in the fair value measurement was the discount rate, which was 24.0%. As these inputs are not observable, the overall fair value measurement of the contingent consideration is classified as Level 3.
Derivative liability
The Company identified embedded derivatives related to the Convertible Notes' conversion option features. Refer to Note 7 to the unaudited condensed consolidated financial statements for further details on the Convertible Notes. The conversion option features associated with the Convertible Notes were deemed embedded derivatives requiring bifurcation. In accordance with ASC 815-40, Derivatives and Hedging Activities, the conversion option features were accounted for as derivative liabilities at the date of issuance with changes in the fair value due to remeasurement recorded each reporting period.
On January 19, 2023, the Company effected a Reverse Stock Split, and upon the effectiveness of the Reverse Stock Split, the Company deemed it appropriate to reassess the conversion features of its Convertible Notes. As noted above, the conversion features were separately bifurcated and accounted for as embedded derivatives. Based on the Company’s reassessment, it has concluded that the conversion features meet the criteria for equity classification and has reclassified the fair value of the bifurcated conversion features to “Additional paid in capital” on the condensed consolidated balance sheet.
The Company was not in compliance with the minimum revenue financial covenant under the Restated Agreement with Deerfield at September 30, 2023.
Under the terms of the Restated Agreement with Deerfield, a breach of a financial covenant is deemed an event of default and, at the election of Deerfield, a default interest of 2.0% can be charged in addition to the applicable interest rate in effect (“contingent interest feature”). The contingent interest feature was identified as an embedded derivative requiring bifurcation at the date of issuance, however the fair value of the embedded derivative was deemed insignificant as an event of default was deemed unlikely and would continue to be insignificant until an event of default occurred. As of September 30, 2023, in connection with the breach of the minimum revenue financial covenant, the Company has recognized a derivative liability related to the contingent interest feature. The contingent interest feature embedded derivative is required to be remeasured at fair value each reporting period with changes in fair value recorded in the condensed consolidated statement of operations.
The Company utilized a binomial lattice model to calculate the fair value of the conversion option features embedded derivative. Significant observable and unobservable inputs include, conversion price, stock price, dividend rate, expected volatility, risk-free rate, and the probability of conversion to common shares at the Base Conversion Rate in the event of a major transaction (e.g., a change in control).
The fair value of the contingent interest feature is calculated as the present value of the expected payments, using significant observable and unobservable inputs, including credit market yields of 20.67% and 24.12%, risk-adjusted discount rates and a probability of default event of 100% for the Convertible Notes.
The binomial lattice and discounted cash flow models are a Level 3 valuation technique because they require the development of significant internal assumptions in addition to observable market indicators. The following tables present information about the Company’s liabilities that are measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):
The following table provides a rollforward of the aggregate fair values of the Company’s liabilities for which fair value is determined by Level 3 inputs (in thousands):
The liability for the current portion of contingent consideration is included in “Accrued and other current liabilities” and the long-term portion is included in “Deferred and contingent consideration” in the condensed consolidated balance sheets.
The liability for the embedded derivative is recorded as “Derivative liability” in the condensed consolidated balance sheets.
The Company recognizes changes in the fair value of the derivative liability as “Change in fair value of derivative liability” in the condensed consolidated statement of operations and changes in the contingent consideration are recognized in “General and administrative” expense in the condensed consolidated statement of operations. |
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Leases |
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| Leases [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases | 6. Leases
Components of lease expense were as follows:
Short-term lease expense for the three and nine months ended September 30, 2023 and 2022 was not material.
Supplemental cash flow information related to operating and finance leases for the nine months ended September 30, 2023 was as follows (in thousands):
Supplemental balance sheet information related to operating and finance leases was as follows (in thousands, except lease term and discount rate):
As of September 30, 2023, maturities of the Company’s operating and finance lease liabilities and sublease income are as follows (in thousands):
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Debt |
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| Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Debt | 7. Debt
*2022 Note includes exit fees of $0.45 million – included in principal and unamortized debt discount and issuance costs
Convertible and 2022 Note
On October 12, 2022, the Company, entered into the “Restated Agreement” that amends and restates the Existing Agreement with Deerfield. In connection with the Restated Agreement, the Company and Deerfield entered into an Exchange Agreement pursuant to which Deerfield exchanged $10.0 million of principal under the Original Note for securities of the Company, reducing the outstanding principal amount of the original convertible note to $50.0 million. Additionally, on the date of the Restated Agreement and pursuant to the terms thereof, the Company issued and sold an additional senior secured convertible note in a principal amount of $23.0 million (the “2022 Note” and, together with the Original Note, the “Convertible Notes”).
Pursuant to the Convertible Notes, Deerfield has the option to demand repayment of all outstanding principal, and any unpaid interest accrued thereon and any other amounts payable under the Restated Agreement (including the Exit Fee (in the case of the 2022 Note) and any make whole amounts), in connection with a Major Transaction (as defined in the Convertible Notes), which shall include, among others, any acquisition or other change of control of the Company; the sale or transfer of assets of the Company equal to more than 50% of the Enterprise Value (as defined in the Convertible Notes) of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time shares of the Company’s common stock are not listed on an Eligible Market (as defined in the Convertible Notes). The Convertible Notes are subject to specified events of default, the occurrence of which would entitle Deerfield to immediately demand repayment of all outstanding principal and accrued interest on the Convertible Note. Such events of default include, among others, failure to make any payment under the Convertible Note when due, failure to observe or perform any covenant under the Restated Agreement or the other transaction documents related thereto (subject to a standard cure period), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgment levied against the Company and a material default by the Company under the Convertible Note.
On the payment, repayment, dischargement, redemption or prepayment of the 2022 Note or upon a Successor Major Transaction Conversion (as defined in the 2022 Note), the Company will pay a non-refundable exit fee equal to 1.95% of the 2022 Note so paid, repaid, discharged, redeemed or prepaid, as the case may be.
The Company used the proceeds from the new 2022 Note to repay in full the outstanding amounts under its Second Amended and Restated Credit and Security Agreement (Term Loan), dated December 31, 2021, by and among the Company, certain of its wholly owned subsidiaries, the lenders party thereto and MidCap Financial Trust, as administrative agent and collateral agent (as amended, amended and restated, supplemented or otherwise modified prior to the date hereof, the “MidCap Term Credit Agreement”) and repay in full the outstanding amounts, and terminate the outstanding commitments, under that certain Amended and Restated Credit and Security Agreement (Revolving Loan), dated as of July 1, 2019, by and among the Company, certain of its wholly owned subsidiaries, the lenders party thereto and MidCap Funding IV Trust, as administrative and collateral agent (as amended, amended and restated, supplemented or otherwise modified prior to the date hereof, the “MidCap Revolving Credit Agreement”).
The Restated Agreement also provides for the issuance of warrants to purchase Common Stock (the “Warrants”) to the extent that the obligations under Restated Agreement and the Convertible Notes are prepaid. If issued, the Warrants will be exercisable on a cash or cashless (net exercise) basis with an initial exercise price equal to the conversion price of the Original Note and 2022 Note, respectively, for the number of Conversion Shares (as defined in the Convertible Notes) which the repaid amount would have been convertible into and will be subject to the Beneficial Ownership Cap, as well as certain other customary anti-dilution adjustments upon the occurrence of certain events such as stock splits, subdivisions, reclassifications or combinations of Common Stock consistent with those included in the Convertible Notes. The Warrants will also provide, at the election of each holder thereof, for the payment of the exercise price therefor by reduction of the principal amount of any outstanding Convertible Notes held by such holder. Upon the consummation of a “Major Transaction” (as defined in the Warrants and consistent with the term as used in the Convertible Notes), holders of the Warrants may elect to (i) have their Warrants redeemed by the Company for an amount equal to the Black-Scholes value of such Warrant, in cash or, if applicable, in the form of the consideration paid to the Company’s stockholders in a Major Transaction, or (ii) have such Warrants be assumed by the successor to the Company in a Major Transaction, if applicable. Holders of the Warrants are also entitled to participate in any dividends or distributions to holders of Common Stock at the time such dividends or distributions are paid to such stockholders. All Warrants under the Exchange Agreement with Deerfield, in connection with the Restated Agreement were exercised as of March 31, 2023. See Note 8 for additional details.
The Company may redeem all or any portion of the principal amount of the Convertible Notes for cash. Upon redemption of any Convertible Notes, the Company will issue Warrants covering the same number of shares of Common Stock underlying, and at an exercise price equal to the conversion price of, the redeemed Convertible Notes. The Convertible Notes provide for the optional redemption of the Convertible Notes without issuance of any Warrants or payment of any additional make whole amount (unless such Convertible Note is converted following receipt of an optional redemption notice but prior to payment of the redemption amount) provided that each of the following is greater than 130% of the conversion price then in effect: (1) the volume weighted average price of the Common Stock on each of any twenty (20) trading days during the period of thirty (30) consecutive trading days ending on the date on which the Company delivers an optional redemption notice, (2) the volume weighted average price of the Common Stock on the last trading day of such period and (3) the closing price of the Common Stock on the last trading day of such period. The Company may not effect any optional redemption during a delisting event or unless all conversion shares and warrant shares are freely tradable.
As of September 30, 2023, there was $73.5 million of outstanding principal, reduced by unamortized debt discount and issuance costs of $14.6 million related to the convertible note included in “Current portion of long-term debt” on the condensed consolidated balance sheets. The Company amortizes the debt discount and debt issuance costs under the effective interest method over the term of the Note, at a resulting effective interest rate of approximately 12%. For the nine months ended September 30, 2023 and 2022, the amortization of the convertible debt discount and issuance costs were $3.6 million and $2.5 million, respectively. Both were included in interest expense in the condensed consolidated statements of operations. The Company is subject to a number of affirmative and restrictive covenants, including covenants regarding compliance with applicable laws and regulations, maintenance of property, payment of taxes, maintenance of insurance, business combinations, incurrence of additional indebtedness, prepayments of other unsecured indebtedness and transactions with affiliates, among other covenants. As of September 30, 2023, the Company was not in compliance with the minimum revenue financial covenant. In the event of default under the Restated Agreement, one of the remedies that Deerfield has available is the ability to accelerate repayment of the debt, which the Company would not be able to immediately repay. Additionally, Deerfield may elect that Default Interest of 2.0% shall be payable in cash on demand in addition to the applicable interest rate then in effect. On October 30, 2023, the Company entered into the Temporary Waiver and Exchange Agreement with Deerfield, which provides for a temporary waiver of the event of default through January 15, 2024. Under the Temporary Waiver, the Company continues to be deemed in default and the uncertainty of the final resolution is unknown. For further details, see Note 12 Subsequent Events. As a result of the above, the Company reclassified the Convertible Notes, net of unamortized debt discount and issuance costs, from a long-term liability to a current liability as of September 30, 2023. Any additional amendments or waiver under the Restated Agreement may result in increased interest rates or premiums and more restrictive covenants and other terms less advantageous to the Company and may require the payment of a fee for such amendments, or waiver. Term Loan and Revolving Loan
As noted above, the Company used the proceeds from the new 2022 Note to repay in full the outstanding amounts under its Term Loan and Revolving loan.
Accordingly, for the current year there was no amount outstanding under the Term Loan and the Revolving Loan and no unamortized debt issuance costs related to the Term Loan and the Revolving Loan.
The amortization of debt issuance costs on the term loan and the revolving loan was $0.2 million for both three months and nine months ended September 30, 2022, and was included in interest expense in the condensed consolidated statements of operations.
Future Principal Payments of Debt
The future principal payments for all outstanding debt as of September 30, 2023 are as follows (in thousands):
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Stockholders' Equity |
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| Share-Based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stockholders' Equity | 8. Stockholders’ Equity (a) Authorized Stock The Company’s Amended and Restated Certificate of Incorporation authorizes the Company to issue 210,000,000 shares of common and preferred stock, consisting of 200,000,000 shares of common stock with $0.01 par value and 10,000,000 shares of preferred stock with $0.01 par value. As of September 30, 2023 and December 31, 2022, the Company had no preferred stock issued or outstanding.
(b) Issuance of Common Stock
2022 Follow-on Public Offering
In October 2022, the Company completed a follow-on public offering of 1,778,500 shares of common stock and pre-funded warrants to purchase up to 2,221,499 shares of common stock and warrants to purchase 3,999,999 shares of common stock, at an offering price of $3.80 per share of common stock and warrant and $3.70 per pre-funded warrant and warrant, before underwriting discounts and commissions. Net proceeds were approximately $14.1 million, after deducting underwriting discounts, debt issuance cost, commissions and estimated expenses payable by the Company. As of September 30, 2023 and December 31, 2022, there were 4,657,799 warrants outstanding related to the follow-on public offering.
Exchange Agreement with Deerfield
In October 2022, the Company entered into an Exchange Agreement with Deerfield, in connection with the Restated Agreement, pursuant to which Deerfield exchanged $10.0 million of principal under the Original Note for 296,774 shares of our common stock and a pre-funded warrant to purchase 1,054,395 shares of our common stock (the "Exchange Warrants"), reducing the outstanding principal amount of the Original Note to $50.0 million. The Exchange Warrants are immediately exercisable, have an exercise price of $0.001 per share, and may be exercised on a cash or cashless basis at any time until all of the Exchange Warrants are exercised in full. Under the terms of the Exchange Warrants, a holder will not be entitled to exercise any portion of any such warrant, if, upon giving effect to such exercise, the aggregate number of shares of Common Stock beneficially owned by the holder (together with its affiliates, any other persons acting as a group together with the holder or any of the holder’s affiliates, and any other persons whose beneficial ownership of Common Stock would or could be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Securities Exchange Act of 1934, as amended) would exceed 4.985% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise.
The Exchange Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, other obligations of the parties, and termination provisions.
As of September 30, 2023 and December 31, 2022, there were 0 and 303,804 warrants outstanding, respectively, related to the Exchange Agreement.
On October 30, 2023, the Company entered into the Temporary Waiver and Exchange Agreement with Deerfield, which provides for the exchange by Deerfield of $1.2 million of principal amount of the Convertible Notes into pre-funded warrants (“Pre-Funded Warrants”) to purchase shares of the Company’s stock, par value $0.01 per share (“Common Stock”). For further details, refer to Note 12 Subsequent Events. (c) Stock Option Plans
In April 2007, the Company adopted the 2007 Equity Incentive Plan, or 2007 Plan. The 2007 Plan provides for the granting of stock options to employees, directors and consultants of the Company. A total of 169,045 shares of the Company’s common stock were reserved for issuance under the 2007 Plan. The Company’s board of directors adopted the 2014 Equity Incentive Plan, or 2014 Plan, in July 2014, and the stockholders approved the 2014 Plan in October 2014. The 2014 Plan became effective upon completion of the IPO on November 3, 2014, at which time the Company ceased granting awards under the 2007 Plan. A total of 102,750 shares of common stock were initially reserved for issuance under the 2014 Plan, subject to certain annual increases.
Pursuant to a board-approved Inducement Plan, the Company may issue NSOs and restricted stock unit awards which may only be granted to new employees of the Company and their affiliates in accordance with NASDAQ Stock Market Rule 5635(c)(4) as an inducement material to such individuals entering into employment with the Company. As of September 30, 2023, a total of 285,137 shares of the Company’s common stock were available for issuance under the 2014 Plan. As of September 30, 2023, inducement grants for 528,221 shares of common stock have been awarded, and 311,961 shares of common stock were reserved for future issuance under the Inducement Plan.
On June 22, 2023, the Company registered an additional 511,128 shares of the Registrant’s common stock to be issued pursuant to the Registrant’s 2016 Equity Inducement Plan.
On April 17, 2023, the Company registered an additional 428,098 shares of the Registrant’s common stock to be issued pursuant to the Registrant’s 2014 Equity Incentive Plan.
Options under the 2007 Plan and the 2014 Plan may be granted for periods of up to ten years as determined by the Company’s board of directors, provided, however, that (i) the exercise price of an ISO shall not be less than 100% of the estimated fair value of the shares on the date of grant, and (ii) the exercise price of an ISO granted to a more than 10% shareholder shall not be less than 110% of the estimated fair value of the shares on the date of grant. An NSO has no such exercise price limitations. NSOs under the Inducement Plan may be granted for periods of up to ten years as determined by the board of directors, provided, the exercise price will be not less than 100% of the estimated fair value of the shares on the date of grant. Options generally vest with 25% of the grant vesting on the first anniversary and the balance vesting monthly on a straight-lined basis over the requisite service period of three additional years for the award. Compensation expense is recognized on a straight-lined basis over the vesting term of one year based upon the probable performance target that will be met. The vesting provisions of individual options may vary but provide for vesting of at least 25% per year. The following summarizes all option activity under the 2007 Plan, 2014 Plan and Inducement Plan:
For stock-based awards the Company recognizes compensation expense based on the grant date fair value using the Black-Scholes option valuation model. Stock-based compensation expense related to stock options for both the three months ended September 30, 2023 and 2022 was $0.2 million. Stock-based compensation expense related to stock options for both the nine months ended September 30, 2023 and 2022 was $0.5 million . (d) Restricted Stock Units The Company has issued restricted stock unit awards, or RSUs, under the 2014 Plan and the Inducement Plan. The RSUs issued to employees generally vest on a straight-line basis annually over a 3-year requisite service period. RSUs issued to non-employees generally vest either monthly or annually over the service term. Activity related to RSUs is set forth below:
Stock-based compensation expense for RSUs for the three months ended September 30, 2023 and 2022 was $0.9 million and $1.5 million, respectively. Stock-based compensation expense for RSUs for the nine months ended September 30, 2023 and 2022 was $3.4 million and $5.2 million, respectively. As of September 30, 2023, there was $4.5 million of total unrecognized compensation costs related to non-vested RSU awards. The cost is expected to be recognized over a weighted average period of approximately 1.33 years. (e) Employee Stock Purchase Plan The Company’s board of directors adopted the 2014 Employee Stock Purchase Plan, or ESPP, in July 2014, and the stockholders approved the ESPP in October 2014. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides for offering periods not to exceed 27 months, and each offering period will include purchase periods, which will be the approximately six-month period commencing with one exercise date and ending with the next exercise date. Employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the purchase date. A total of 255,500 shares of common stock were initially reserved for issuance under the ESPP, subject to certain annual increases. During the nine months ended September 30, 2023, employees purchased 244,726 shares of common stock at a weighted average price of $1.75 per share. As of September 30, 2023, the number of shares of common stock available for future issuance for the ESPP was 15,558. On April 17, 2023, the Company registered an additional 107,024 shares of the Registrant’s common stock to be issued pursuant to the Registrant’s 2014 Employee Stock Purchase Plan. The Company estimated the fair value of employee stock purchase rights using the Black-Scholes model. Stock-based compensation expense related to the ESPP for both the three months ended September 30, 2023 and 2022 was $0.1 million. Stock-based compensation expense related to the ESPP was $0.4 million for both the nine months ended September 30, 2023 and 2022. |
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Net Loss Per Share |
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| Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss Per Share | 9. Net Loss Per Share Basic net loss per share attributable to common stockholders is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted net loss per share is computed by dividing net loss available to common stockholders by the weighted average number of common shares and dilutive potential common share equivalents then outstanding, to the extent they are dilutive. Potential dilutive shares consist of shares that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Dilutive net loss per share is the same as basic net loss per share for all periods presented because the effects of potentially dilutive items were anti-dilutive (in thousands, except per share and share amounts).
The Company excluded the following weighted average potentially dilutive securities, outstanding for the three and nine months ended September 30, 2023 and 2022, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2023 and 2022 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.
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Income Taxes |
9 Months Ended |
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Sep. 30, 2023 | |
| Income Tax Disclosure [Abstract] | |
| Income Taxes | 10. Income Taxes The Company operates in several tax jurisdictions and is subject to taxes in each jurisdiction in which it conducts business. To date, the Company has incurred cumulative net losses and maintains a full valuation allowance on its net deferred tax assets due to the uncertainty surrounding realization of such assets. The Company had no tax expense for both the three and nine months ended September 30, 2023 and 2022. |
Commitments and Contingencies |
9 Months Ended |
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Sep. 30, 2023 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies | 11. Commitments and Contingencies The Company is subject to claims and assessment from time to time in the ordinary course of 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. Product Liability Litigation
On October 7, 2019, a lawsuit was filed in the Superior Court of the State of California against the Company and Silimed Industria de Implantes Ltda. (the Company’s former contract manufacturer). The lawsuit alleges that the Company’s textured breast implants caused certain of the plaintiffs to develop a condition known as breast implant associated anaplastic large cell lymphoma (“BIA-ALCL”), and that the Company is liable to the plaintiffs based on claims for strict liability (failure to warn), strict liability (defective manufacture), negligence and loss of consortium. On January 21, 2020, the Company filed a demurrer to the plaintiff’s complaint, which demurrer the Court granted in a tentative ruling dated March 9, 2021 with leave to replead. The Plaintiffs filed an amended complaint on April 6, 2021 and the Company filed a demurrer to that complaint on May 6, 2021. On October 25, 2021, the Court issued a ruling granting the Company’s demurrer in-part and denying it in-part, and gave plaintiffs twenty days to file an amendment complaint. On August 3, 2022, the Company entered into confidential settlement agreements with the plaintiffs resolving all disputes between them and dismissing the plaintiffs’ claims with prejudice. The Court granted the dismissal with prejudice on August 4, 2022.
On September 23, 2020, a lawsuit was filed in the Eastern District of Tennessee against the Company. The lawsuit also alleges that the Company’s textured breast implants caused certain of the plaintiffs to develop BIA-ALCL, and that the Company is liable to the plaintiffs based on claims for negligence, strict liability (manufacturing defects), strict liability (failure to warn), breach of express and implied warranties, and punitive damages. The Company filed a motion to dismiss the complaint on December 7, 2020. On February 28, 2022 the Court granted the Company’s motion, and dismissed the plaintiff’s complaint with prejudice. On March 28, 2022, the plaintiffs filed a motion to alter or amend the judgment. The Company opposed that motion on April 11, 2022. On March 31, 2023 the Court denied plaintiffs motion, and the plaintiffs have not filed any timely appeal from the Court’s denial of their motion.
Grand Jury and SEC Subpoenas
The Company received a grand jury subpoena dated September 30, 2022 from the U.S. Department of Justice (“DOJ”) requesting the production of materials concerning the trading activities of a former Chief Executive Officer of the Company in 2019 and 2020, including all documents and communications with the General Counsel regarding such activities. In addition, the SEC has subpoenaed documents and testimony from each of the Company and its General Counsel, as reported by the Company in its Form 8-K filing dated October 11, 2022. Each of the SEC subpoenas is captioned “In the Matter of Trading in the Securities of Sientra, Inc.” The SEC subpoenas request, among other things, documents and communications relating to trading activities by each of the aforementioned individuals. The investigation by the SEC does not mean that the SEC has concluded that anyone has violated the law. Also, the investigation does not mean that the SEC has a negative opinion of any person, entity or security. On April 13, 2023, the DOJ informed the Company that the DOJ did not intend to pursue prosecutions relating to the subpoena and was closing its file with respect to the Company. On August 15, 2023, the SEC informed the Company that the SEC did not intend to recommend enforcement actions against the Company or its General Counsel. |
Subsequent Events |
9 Months Ended |
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Sep. 30, 2023 | |
| Subsequent Events [Abstract] | |
| Subsequent Events | 12. Subsequent Events
On October 30, 2023 (the “Effective Date”), in connection with our non-compliance with the minimum revenue financial covenant of the Restated Agreement, the Company entered into the Temporary Waiver and Exchange Agreement under the Restated Agreement.
The Temporary Waiver and Exchange Agreement, among other matters, provides: (i) for a temporary waiver of the event of default that has occurred and is continuing under Section 7.1(b) of the Restated Agreement as a result of the Company’s failure to satisfy the minimum revenue financial covenant for the fiscal quarter ending September 30, 2023 (the “Specified Event of Default”) set forth in Section 6.10 of the Restated Agreement until the earliest to occur of (A) the first date following the Effective Date on which an Event of Default (as defined in the Restated Agreement) has occurred, other than the Specified Event of Default, (B) the failure of the Company, or the failure of the Company’s subsidiaries party to the Restated Agreement, to comply with any term, condition or covenant set forth in the Temporary Waiver and Exchange Agreement and (C) January 15, 2024 (the “Waiver Period”); (ii) for the exchange by Deerfield of $1.2 million of principal amount of the Note into a pre-funded warrant (a “Pre-Funded Warrant”) to purchase 886,635 shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”), based upon 105.75% of the aggregate principal amount of the Note exchanged, plus the amount of accrued and unpaid interest thereon at an exchange rate equal to the Nasdaq official closing price of the Common Stock as of the Effective Date; and (iii) on or before January 15, 2024, Deerfield may (in its sole discretion) elect for the Company to convert up to an additional $18.8 million in aggregate of the principal amount of the Note into one or more Pre-Funded Warrants to purchase additional shares of the Company’s Common Stock, based upon 105.75% of the aggregate principal amount of the Note to be converted, plus the amount of accrued and unpaid interest thereon at an conversion rate equal to the Nasdaq official closing price of the Common Stock as of the Effective Date.
The Pre-Funded Warrants have an exercise price of $0.01 per share and are exercisable at any time after issuance until such Pre-Funded Warrants have been fully exercised in accordance with their terms. The Pre-Funded Warrants are subject to a limitation on the ability to exercise if Deerfield’s beneficial ownership of Common Stock (together with its affiliates and certain attribution parties) would exceed 4.985% of the outstanding Common Stock.
In addition, during the Waiver Period, for purposes of determining whether or not certain actions are permitted to be taken by or on behalf of the Company or any other loan party upon the satisfaction of any term, condition or requirement in the Restated Agreement or any other Facility Document (as defined in the Restated Agreement) that a default or event of default shall not have occurred and be continuing, the Specified Event of Default shall be deemed to have occurred and be continuing in respect of any such term, condition or requirement, except as set forth in the Temporary Waiver and Exchange Agreement. |
Summary of Significant Accounting Policies (Policies) |
9 Months Ended |
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Sep. 30, 2023 | |
| Accounting Policies [Abstract] | |
| Basis of Presentation | a. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of Sientra, Inc. (“Sientra”, the “Company”, “we”, “our”, or “us”) in this Quarterly Report on Form 10-Q have been prepared in accordance with U.S. generally accepted accounting principles, or "GAAP", and the rules and regulations of the U.S. Securities and Exchange Commission, or the "SEC". Accordingly, they do not include certain notes and financial presentations normally required under GAAP for complete financial reporting. The interim financial information is unaudited, but reflects all normal adjustments and accruals which are, in the opinion of management, considered necessary to provide a fair presentation for the interim periods presented. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on April 18, 2023, or the Annual Report. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period.
Reverse Stock Split
On January 19, 2023, the Company effected a 1-for-10 reverse stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding common stock, par value $0.01 per share (the “Common Stock”) by the filing of a Certificate of Amendment (the “Certificate”) with the Secretary of State of the State of Delaware pursuant to the Delaware General Corporation Law. The Reverse Stock Split became effective on January 19, 2023.
As a result of the Reverse Stock Split, every 10 shares of Common Stock issued and outstanding were automatically reclassified into one new share of common stock. The Reverse Stock Split did not modify any rights or preferences of the shares of Common Stock. Proportionate adjustments were made to the exercise or conversion prices and the number of shares underlying the Company’s outstanding equity awards, convertible securities and warrants, as well as to the number of shares issued and issuable under the Company’s equity incentive plans. The Common Stock issued pursuant to the Reverse Stock Split remained fully paid and non-assessable. The Reverse Stock Split did not affect the number of authorized shares of Common Stock or the par value of the Common Stock. All share information in the accompanying financial statements has been adjusted to reflect the results of the Reverse Stock Split.
Discontinued Operations of miraDry As a result of the miraDry sale discussed in Note 2, the miraDry business met the criteria to be reported as discontinued operations. Therefore, the Company is reporting the historical results of miraDry, including the results of operations, cash flows, and related assets and liabilities, as discontinued operations for all periods presented herein through the date of the Sale. Unless otherwise noted, the accompanying notes to the unaudited condensed consolidated financial statements have all been revised to reflect continuing operations only. Following the sale the Company has one operating segment in continuing operations named Plastic Surgery, formerly known as Breast Products. |
| Liquidity and Going Concern | b. Liquidity and Going Concern
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared assuming the Company will continue as a going concern and in accordance with GAAP. The going concern basis of presentation assumes that the Company will continue in operation one year after the date these financial statements are issued and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.
Pursuant to the requirements of the Financial Accounting Standards Board’s Accounting Standards Codification (“ASC”) Topic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date these condensed consolidated financial statements are issued. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the condensed consolidated financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.
Recurring Operating Losses
Since the Company’s inception, it has incurred recurring losses and cash outflows from operations and the Company anticipates that losses will continue in the near term. During the nine months ended September 30, 2023, the Company incurred net losses of $37.1 million and used $10.2 million of cash in operating activities. As of September 30, 2023, the Company had cash and cash equivalents of $15.0 million. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern for a period of at least one year from the date of issuance of these unaudited condensed consolidated financial statements. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
To alleviate these conditions, management is currently evaluating various cost-saving measures to reduce operating expenses and cash outflows. However, the Company will need to generate a significant increase in net sales to further improve profitability and cash inflows, which is dependent upon continued growth in our Plastic Surgery segment and the launch of new products and partnerships. Additionally, we are evaluating various funding alternatives to improve liquidity and may seek to raise additional equity or debt capital, refinance our debt obligations or obtain waivers, and/or scale back or freeze our organic growth plans to manage our liquidity and capital resources. As the Company seeks additional sources of financing, there can be no assurance that such financing would be available to the Company on favorable terms or at all. The Company’s ability to obtain additional financing in the equity capital markets is subject to several factors, including market and economic conditions, the Company’s performance and investor sentiment with respect to the Company and its industry.
During 2022, to fund ongoing operating and capital needs, the Company raised additional capital through the sale of equity securities and incremental debt financing. See Note 7 to the condensed consolidated financial statements for further details.
Financial Covenants
The Company was not in compliance with its financial covenants related to minimum revenue under the Amended and Restated Facility Agreement (“Restated Agreement”) with Deerfield at September 30, 2023. Under the terms of the Restated Agreement, the breach of the minimum revenue financial covenant is deemed an event of default. Under the Restated Agreement, in the event of default, Deerfield may elect that Default Interest of 2.0% shall be payable in cash on demand in addition to the applicable interest rate then in effect. Without a waiver or other relief under the Restated Agreement, one of the remedies that Deerfield has available to it, amongst others, is the ability to accelerate repayment of the debt, which the Company would not be able to immediately repay. The potential acceleration of the debt by Deerfield resulted in the reclassification of debt from a long-term liability to a current liability as of September 30, 2023.
On October 30, 2023, the Company entered into a Temporary Waiver and Exchange Agreement (the "Temporary Waiver and Exchange Agreement”) with Deerfield, which provides for a temporary waiver of the event of default through January 15, 2024. For further details, see Note 12 Subsequent Events.
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| Recent Accounting Pronouncements | c. Recent Accounting Pronouncements
Recently Adopted Accounting Standards
In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. The amendment eliminates certain accounting models and simplifies the accounting for convertible instruments and enhances disclosures for convertible instruments and earnings per share. The amendments are effective for public entities excluding smaller reporting companies for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023 including interim periods within those fiscal years and early adoption is permitted. The Company adopted this guidance effective January 1, 2023 under the modified retrospective adoption approach and there was no material impact on its consolidated financial statements from the adoption.
Recently Issued Accounting Standards
In December 2022, the FASB issued ASU 2022-06, Deferral of the Sunset Date of Topic 848 that extends the period of time preparers can utilize the reference rate reform relief guidance. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. To ensure the relief in Topic 848 covers the period of time during which a significant number of modifications may take place, the ASU defers the sunset date of Topic 848 from December 31, 2022, to December 31, 2024, after which entities will no longer be permitted to apply the relief in Topic 848. The Company is currently evaluating the impact the election of the optional expedient will have on the consolidated financial statements. |
| Risks and Uncertainties | d. Risks and Uncertainties
The COVID-19 pandemic continues to have a lingering effect on our business and results of operations, although to a lesser extent than in prior years. At the height of the pandemic and as an aesthetics company, the surgical procedures involving our breast products were susceptible to local and national government restrictions. The inability or limited ability to perform non-emergency procedures significantly harmed our revenues starting in the second quarter of 2020 and lasting through the first quarter of 2022. While restrictions on non-emergency procedures have been removed, there is still substantial uncertainty as to when, if at all, the aesthetic procedures that the Company’s products are sold into will return to pre-pandemic levels.
In addition, the global economy, including the financial and credit markets, has recently experienced extreme volatility and disruptions, including increases to inflation rates, rising interest rates, declines in consumer confidence, declines in economic growth, and uncertainty about economic stability. The severity and duration of the impact of these conditions on our business cannot be predicted.
The estimates used for, but not limited to, determining the collectability of accounts receivable, fair value of long-lived assets and goodwill, and sales returns liability required could be impacted by the factors described above. While the full impact and duration of the factors noted above is unknown at this time, the Company has made appropriate estimates based on the facts and circumstances available as of the reporting date. These estimates may change as new events occur and additional information is obtained. |
Discontinued Operations (Tables) |
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Sep. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Discontinued Operations and Disposal Groups [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Disposal Groups Including Discontinued Operations Balance Sheet and Income Statement | The following table presents the aggregate carrying amounts of major classes of assets and liabilities of discontinued operations (in thousands):
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Revenue (Tables) |
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| Revenue from Contract with Customer [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Rollforward of Sales Return Liability | The liability for unsatisfied performance obligations under the service warranty as of September 30, 2023 was as follows (in thousands):
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| Schedule of Liability for Unsatisfied Performance Obligations Under Service Warranty |
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Fair Value of Financial Instruments (Tables) |
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| Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Carrying Value and Fair Value of Convertible Note | As of September 30, 2023 and December 31, 2022, the carrying value and fair value of the Convertible Notes were as follows (in thousands):
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Balance Sheet Components (Tables) |
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| Balance Sheet Related Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of inventories | Inventories consist of the following (in thousands):
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| Schedule of property and equipment, net | Property and equipment, net consist of the following (in thousands):
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| Schedule of Other Intangible assets | The components of the Company’s other intangible assets consist of the following (in thousands):
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| Schedule of Future Estimated Amortization Expense | The following table summarizes the future estimated amortization expense relating to the Company's definite-lived intangible assets as of September 30, 2023 (in thousands):
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| Schedule of accrued and other current liabilities | Accrued and other current liabilities consist of the following (in thousands):
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| Schedule of rollforward of the accrued assurance-type warranties | The following table provides a rollforward of the accrued assurance-type warranties (in thousands):
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| Schedule of Company's Liabilities that are Measured at Fair Value on a Recurring Basis | The following tables present information about the Company’s liabilities that are measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):
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| Schedule of Aggregate Fair Values of Company's Liabilities for which Fair Value is Determined by Level 3 Inputs | The following table provides a rollforward of the aggregate fair values of the Company’s liabilities for which fair value is determined by Level 3 inputs (in thousands):
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Leases (Tables) |
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| Leases [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Components of Lease Expense | Components of lease expense were as follows:
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| Supplemental Cash Flow Information Related to Operating and Finance Leases | Supplemental cash flow information related to operating and finance leases for the nine months ended September 30, 2023 was as follows (in thousands):
|
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| Supplemental Balance Sheet Information Related to Operating and Finance Leases | Supplemental balance sheet information related to operating and finance leases was as follows (in thousands, except lease term and discount rate):
|
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| Maturities of Operating and Finance Lease Liabilities | As of September 30, 2023, maturities of the Company’s operating and finance lease liabilities and sublease income are as follows (in thousands):
|
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Debt (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Carrying Value of our Long-Term Debt |
*2022 Note includes exit fees of $0.45 million – included in principal and unamortized debt discount and issuance costs |
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| Schedule of Future Principal Payments for Outstanding Debt | The future principal payments for all outstanding debt as of September 30, 2023 are as follows (in thousands):
|
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Stockholders' Equity (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Payment Arrangement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of option activity | The following summarizes all option activity under the 2007 Plan, 2014 Plan and Inducement Plan:
|
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| Summary of RSUs activity | Activity related to RSUs is set forth below:
|
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Net Loss Per Share (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of net loss per share, basic and diluted |
|
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| Schedule of weighted average potentially dilutive securities excluded from the computation of diluted net loss per share attributable to common stockholders | The Company excluded the following weighted average potentially dilutive securities, outstanding for the three and nine months ended September 30, 2023 and 2022, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2023 and 2022 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.
|
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Discontinued Operations - Summary of Aggregate Carrying Amounts of Major Classes of Assets and Liabilities of Discontinued Operations (Details) $ in Thousands |
Sep. 30, 2023
USD ($)
|
|---|---|
| Assets of discontinued operations: | |
| Prepaid expenses and other current assets | $ 4 |
| Total assets of discontinued operations | 4 |
| Liabilities of discontinued operations: | |
| Accounts payable | 6 |
| Accrued and other current liabilities | 209 |
| Total liabilities of discontinued operations | $ 215 |
Discontinued Operations - Summary of Information Regarding the Results of Discontinued Operations (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended |
|---|---|---|
Sep. 30, 2022 |
Sep. 30, 2022 |
|
| Discontinued Operation, Income (Loss) from Discontinued Operation Disclosures [Abstract] | ||
| Net sales | $ 0 | $ 0 |
| Cost of goods sold | 0 | 0 |
| Gross profit | 0 | 0 |
| Operating expenses | 94 | 208 |
| Loss from operations of discontinued operations | (94) | (208) |
| Other income (expense), net | 0 | 0 |
| Loss from discontinued operations before income taxes | (94) | (208) |
| Loss on sale of discontinued operations before income taxes | 0 | 0 |
| Total loss from discontinued operations before income taxes | (94) | (208) |
| Income tax expense (benefit) | 0 | 0 |
| Loss from discontinued operations, net of income taxes | $ (94) | $ (208) |
Revenue (Details 1) - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-04-01 |
Sep. 30, 2023 |
|---|---|
| Product Replacement | |
| Revenue From Contracts With Customers [Line Items] | |
| Performance obligation satisfying period | 20 years |
| Breast Products and Consumable miraDry products | |
| Revenue From Contracts With Customers [Line Items] | |
| Performance obligation satisfying period | 30 days |
| Maximum | Financial Assistance | |
| Revenue From Contracts With Customers [Line Items] | |
| Performance obligation satisfying period | 24 months |
| Minimum | Financial Assistance | |
| Revenue From Contracts With Customers [Line Items] | |
| Performance obligation satisfying period | 3 months |
Revenue (Details) |
9 Months Ended |
|---|---|
Sep. 30, 2023 | |
| Change in Contract with Customer, Liability [Abstract] | |
| Period for sales return | 6 months |
Revenue - Schedule of Liability for Unsatisfied Performance Obligations Under Service Warranty and Deliverables Under Certain Marketing Programs (Details) $ in Thousands |
9 Months Ended |
|---|---|
|
Sep. 30, 2023
USD ($)
| |
| Change in Contract with Customer, Liability [Abstract] | |
| Balance as of December 31, 2022 | $ 3,508 |
| Additions and adjustments, net | 107 |
| Revenue recognized | (1,119) |
| Balance as of September 30, 2023 | 2,496 |
| Less short-term portion | (498) |
| Long-term portion | $ 1,998 |
Revenue - Schedule of Rollforward of Sales Return Liability (Details) - USD ($) $ in Thousands |
9 Months Ended | |
|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Revenue Recognition [Abstract] | ||
| Beginning balance | $ 15,773 | $ 13,399 |
| Addition to reserve for sales activity | 139,129 | 130,968 |
| Actual returns | (141,157) | (132,351) |
| Ending balance | $ 13,745 | $ 12,016 |
Fair Value of Financial Instruments - Schedule of Carrying Value and Fair Value of Convertible Note (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Convertible Note | ||
| Debt Instrument [Line Items] | ||
| Carrying Value | $ 42,219 | $ 40,423 |
| Fair Value | 35,802 | 33,794 |
| 2022 Note | ||
| Debt Instrument [Line Items] | ||
| Carrying Value | 16,591 | 15,396 |
| Fair Value | $ 18,152 | $ 16,495 |
Balance Sheet Components (Inventories) (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Balance Sheet Related Disclosures [Abstract] | ||
| Raw materials | $ 3,488 | $ 2,765 |
| Work in progress | 2,997 | 4,245 |
| Finished goods | 29,486 | 31,438 |
| Finished goods - right of return | 3,297 | 4,244 |
| Inventories | $ 39,268 | $ 42,692 |
Balance Sheet Components - Goodwill and Other Intangible Assets, net (Details) $ in Thousands |
3 Months Ended | 9 Months Ended | |||
|---|---|---|---|---|---|
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
ReportingUnit
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
|
| Finite-Lived Intangible Assets [Line Items] | |||||
| Number of reporting units | ReportingUnit | 1 | ||||
| Goodwill | $ 9,202 | $ 9,202 | $ 9,202 | ||
| Other intangible assets | |||||
| Amortization expense | 1,000 | $ 900 | 2,800 | $ 2,800 | |
| Plastic Surgery | |||||
| Finite-Lived Intangible Assets [Line Items] | |||||
| Goodwill | $ 9,200 | $ 9,200 | $ 9,200 | ||
Balance Sheet Components - Schedule of Future Estimated Amortization Expense (Details) $ in Thousands |
Sep. 30, 2023
USD ($)
|
|---|---|
| Estimated amortization expense | |
| 2023 | $ 999 |
| 2024 | 3,851 |
| 2025 | 3,708 |
| 2026 | 3,535 |
| 2027 | 3,454 |
| Thereafter | 8,335 |
| Total amortization | $ 23,882 |
Balance Sheet Components (Accrued liabilities) (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Accrued and other current liabilities | ||
| Accrued payroll and bonuses | $ 5,630 | $ 4,962 |
| Accrued severance | 720 | 1,232 |
| Accrued commissions | 670 | 3,017 |
| Deferred and contingent consideration, current portion | 5,795 | 3,030 |
| Lease liabilities | 1,839 | 1,823 |
| Other | 6,001 | 8,535 |
| Total | $ 20,655 | $ 22,599 |
Balance Sheet Components - Schedule of rollforward of the accrued assurance-type warranties (Details) - USD ($) $ in Thousands |
9 Months Ended | |
|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
| Balance as of January 1 | $ 8,828 | $ 2,505 |
| Warranty costs incurred during the period | (797) | (413) |
| Changes in accrual related to warranties issued during the period | 1,152 | 633 |
| Changes in accrual related to warranties issued during prior periods | 357 | (50) |
| Balance as of September 30 | 9,540 | 2,675 |
| Less short-term portion | (782) | 0 |
| Long-term portion | $ 8,758 | $ 2,675 |
Balance Sheet Components (Liabilities measured at fair value) (Details) |
9 Months Ended |
|---|---|
Sep. 30, 2023 | |
| Measurement Input, Discount Rate | BIOCORNEUM | Future Royalty Payments | |
| Fair Value Measurements | |
| Fair value measurement discount rate | 24.00% |
| Monte-Carlo Simulation Model | Measurement Input, Volatility Rate | |
| Fair Value Measurements | |
| Fair value measurement, volatility rate | 95.00% |
Balance Sheet Components - Schedule of Company's Liabilities that are Measured at Fair Value on a Recurring Basis (Details) - Recurring - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Fair Value Measurements | ||
| Fair value liability | $ 7,474 | $ 3,695 |
| Embedded Derivative Liability | ||
| Fair Value Measurements | ||
| Fair value liability | 3,153 | 880 |
| Contingent Consideration Liability | ||
| Fair Value Measurements | ||
| Fair value liability | 4,321 | 2,815 |
| Level 3 | ||
| Fair Value Measurements | ||
| Fair value liability | 7,474 | 3,695 |
| Level 3 | Embedded Derivative Liability | ||
| Fair Value Measurements | ||
| Fair value liability | 3,153 | 880 |
| Level 3 | Contingent Consideration Liability | ||
| Fair Value Measurements | ||
| Fair value liability | $ 4,321 | $ 2,815 |
Balance Sheet Components - Schedule of Aggregate Fair Values of Company's Liabilities for which Fair Value is Determined by Level 3 Inputs (Details) - Level 3 - Fair Value, Recurring $ in Thousands |
9 Months Ended |
|---|---|
|
Sep. 30, 2023
USD ($)
| |
| Fair Value Measurements | |
| Balance at beginning of the period | $ 3,695 |
| Balance at the end of the period | 7,474 |
| Embedded Derivative Liability | |
| Fair Value Measurements | |
| Reclassification to equity | (880) |
| Change in fair value | 3,153 |
| Contingent Consideration Liability | |
| Fair Value Measurements | |
| Change in fair value | $ 1,506 |
Leases - Components of Lease Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Lessee Lease Description [Line Items] | ||||
| Total operating lease cost | $ 578 | $ 393 | $ 1,339 | $ 926 |
| Finance lease cost | ||||
| Total finance lease cost | 4 | 14 | 22 | 42 |
| Total lease cost | 582 | 407 | 1,361 | 968 |
| Operating Expenses | ||||
| Lessee Lease Description [Line Items] | ||||
| Total operating lease cost | 508 | 578 | 1,439 | 1,429 |
| Sublease income | (28) | (287) | (393) | (826) |
| Finance lease cost | ||||
| Amortization of right-of-use assets | 0 | 0 | 4 | 3 |
| Other Income (Expense), Net | ||||
| Finance lease cost | ||||
| Interest on lease liabilities | 0 | 1 | 1 | 3 |
| Cost of goods sold | ||||
| Lessee Lease Description [Line Items] | ||||
| Total operating lease cost | 98 | 102 | 293 | 323 |
| Finance lease cost | ||||
| Amortization of right-of-use assets | $ 4 | $ 13 | $ 17 | $ 36 |
Leases - Supplemental Cash Flow Information Related to Operating and Finance Leases (Details) - USD ($) $ in Thousands |
9 Months Ended | |
|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash outflows from operating leases | $ 1,810 | $ 1,277 |
| Operating cash outflows from finance leases | 23 | 40 |
| Right-of-use assets obtained in exchange for lease obligations: | ||
| Operating leases | $ 0 | $ 1,542 |
Leases - Supplemental Cash Flow Information Related to Operating and Finance Leases (Parenthetical) (Details) - USD ($) |
9 Months Ended | |
|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Lessee Disclosure [Abstract] | ||
| Operating leases, net of tenant improvement allowances | $ 1,100 | $ 1,100 |
Debt (Details) - USD ($) |
3 Months Ended | 9 Months Ended | ||||
|---|---|---|---|---|---|---|
Oct. 30, 2023 |
Oct. 12, 2022 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Oct. 30, 2022 |
|
| Line Of Credit Facility [Line Items] | ||||||
| Additional interest (as a percent) | 2.00% | |||||
| Amortization of debt issuance costs and discounts | $ 3,621,000 | $ 3,029,000 | ||||
| Debt Instrument principal amount | $ 10,000,000 | |||||
| Term Loan and Revolving Loan | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Loan amount outstanding | 0 | |||||
| Unamortized debt issuance costs | $ 0 | |||||
| Amortization of debt issuance costs | $ 200,000 | 200,000 | ||||
| Deerfield Facility Agreement | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Additional interest (as a percent) | 2.00% | |||||
| Deerfield Facility Agreement | Convertible Note | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Loan amount outstanding | $ 73,500,000 | |||||
| Term loan credit and security agreement entered date | Oct. 12, 2022 | |||||
| Additional interest (as a percent) | 2.00% | |||||
| Unamortized debt discount and issuance costs | $ 14,600,000 | |||||
| Debt instrument interest rate | 12.00% | |||||
| Amortization of debt issuance costs and discounts | $ 3,600,000 | $ 2,500,000 | ||||
| Debt instrument, call feature | Deerfield has the option to demand repayment of all outstanding principal, and any unpaid interest accrued thereon and any other amounts payable under the Restated Agreement (including the Exit Fee (in the case of the 2022 Note) and any make whole amounts), in connection with a Major Transaction (as defined in the Convertible Notes), which shall include, among others, any acquisition or other change of control of the Company; the sale or transfer of assets of the Company equal to more than 50% of the Enterprise Value (as defined in the Convertible Notes) of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time shares of the Company’s common stock are not listed on an Eligible Market (as defined in the Convertible Notes). The Convertible Notes are subject to specified events of default, the occurrence of which would entitle Deerfield to immediately demand repayment of all outstanding principal and accrued interest on the Convertible Note. Such events of default include, among others, failure to make any payment under the Convertible Note when due, failure to observe or perform any covenant under the Restated Agreement or the other transaction documents related thereto (subject to a standard cure period), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgment levied against the Company and a material default by the Company under the Convertible Note. | |||||
| Percentage of transfer of assets | 50.00% | |||||
| Amended and Restated Facility Agreement | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Debt Instrument principal amount | $ 23,000,000 | |||||
| Exit fee percentage to aggregate amount of all term loans funded | 1.95% | |||||
| Debt conversion, threshold percentage | 130.00% | |||||
| Amended and Restated Facility Agreement | Convertible Note | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Principal debt amount exchanged | $ 10,000,000 | |||||
| Debt Instrument principal amount | $ 50,000,000 | |||||
| Temporary Waiver And Exchange Agreement | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Expiration date of facility agreement | Jan. 15, 2024 | |||||
| Temporary Waiver And Exchange Agreement | Subsequent Event | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Expiration date of facility agreement | Jan. 15, 2024 | |||||
| Temporary Waiver And Exchange Agreement | Convertible Note | Subsequent Event | ||||||
| Line Of Credit Facility [Line Items] | ||||||
| Term loan credit and security agreement entered date | Oct. 30, 2023 | |||||
Debt - Schedule of Carrying Value of our Long-Term Debt (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
||
|---|---|---|---|---|
| Line of Credit Facility [Line Items] | ||||
| Convertible Note | $ 50,000 | $ 50,000 | ||
| 2022 Note | [1] | 23,449 | 23,449 | |
| Total carrying amount | 73,449 | 73,449 | ||
| Unamortized debt discount and issuance costs | (14,639) | (18,043) | ||
| Total - carrying amount, net | $ 58,810 | $ 55,406 | ||
| ||||
Debt - Schedule of Carrying Value of our Long-Term Debt (Parenthetical) (Details) $ in Thousands |
9 Months Ended |
|---|---|
|
Sep. 30, 2023
USD ($)
| |
| Debt Disclosure [Abstract] | |
| Long Term Debt Exit Fees | $ 450 |
Debt - Schedule of Future Principal and Exit Fee Payments of Outstanding Debt (Details) $ in Thousands |
Sep. 30, 2023
USD ($)
|
|---|---|
| Debt Disclosure [Abstract] | |
| 2023 | $ 73,449 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 | 0 |
| 2027 and thereafter | 0 |
| Total | $ 73,449 |
Stockholders' Equity (Details) - $ / shares |
1 Months Ended | |||
|---|---|---|---|---|
Oct. 31, 2022 |
Sep. 30, 2023 |
Jan. 19, 2023 |
Dec. 31, 2022 |
|
| Stock other disclosures | ||||
| Common and preferred stock, shares authorized | 210,000,000 | 210,000,000 | ||
| Common stock, shares authorized | 200,000,000 | 200,000,000 | ||
| Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | |
| Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||
| Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||
| Preferred stock, shares issued | 0 | 0 | ||
| Preferred stock, shares outstanding | 0 | 0 | ||
| 2022 Follow-on Public Offering | Common stock | ||||
| Stock other disclosures | ||||
| Stock issued during period, shares | 1,778,500 | |||
| 2022 Follow-on Public Offering | Stock issuable upon exercise of warrants | ||||
| Stock other disclosures | ||||
| Stock issued during period, shares | 3,999,999 | |||
| 2022 Follow-on Public Offering | Pre-funded Warrant | ||||
| Stock other disclosures | ||||
| Stock issued during period, shares | 2,221,499 |
Stockholders' Equity (Restricted Stock) (Details) - Restricted stock units - 2014 Plan - USD ($) $ / shares in Units, $ in Millions |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
|
| Stockholders' Equity, other disclosures | |||||
| Requisite service period, annually | 3 years | ||||
| Stock-based compensation expense | $ 0.9 | $ 1.5 | $ 3.4 | $ 5.2 | |
| Unrecognized compensation costs (in dollars) | $ 4.5 | $ 4.5 | |||
| Weighted average period over which unrecognized compensation costs are expected to be recognized | 1 year 3 months 29 days | ||||
| Number of shares | |||||
| Balance at beginning of the period | 708,806 | 279,956 | 279,956 | ||
| Granted | 610,630 | 550,229 | |||
| Vested | (168,146) | (88,035) | |||
| Forfeited | (77,040) | (33,344) | |||
| Balance at end of the period | 1,074,250 | 1,074,250 | 708,806 | ||
| Weighted average grant date fair value | |||||
| Balance at beginning of the period | $ 43.86 | $ 81.1 | $ 81.1 | ||
| Granted | 1.75 | 16.49 | |||
| Vested | 25.09 | 6.09 | |||
| Forfeited | 23.12 | 4.67 | |||
| Balance at end of the period | $ 24.35 | $ 24.35 | $ 43.86 | ||
Net Loss Per Share - Schedule of Net Loss Per Share, Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | ||||||
|---|---|---|---|---|---|---|---|---|
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Earnings Per Share [Abstract] | ||||||||
| Loss from continuing operations | $ (14,773) | $ (14,887) | $ (37,142) | $ (51,118) | ||||
| Loss from discontinued operations, net of income taxes | 0 | (94) | 0 | (208) | ||||
| Net loss | $ (14,773) | $ (9,477) | $ (12,892) | $ (14,981) | $ (18,304) | $ (18,041) | $ (37,142) | $ (51,326) |
| Weighted Average Number of Shares Outstanding, Basic | 11,290,699 | 6,284,817 | 11,488,310 | 6,261,350 | ||||
| Weighted Average Number of Shares Outstanding, Diluted | 11,290,699 | 6,284,817 | 11,488,310 | 6,261,350 | ||||
| Continuing operations, Basic | $ (1.31) | $ (2.37) | $ (3.23) | $ (8.16) | ||||
| Continuing operations, Diluted | (1.31) | (2.37) | (3.23) | (8.16) | ||||
| Discontinued operations, Basic | 0 | (0.01) | 0 | (0.03) | ||||
| Discontinued operations, Diluted | 0 | (0.01) | 0 | (0.03) | ||||
| Basic net loss income per share | (1.31) | (2.38) | (3.23) | (8.19) | ||||
| Diluted net loss income per share | $ (1.31) | $ (2.38) | $ (3.23) | $ (8.19) | ||||
Net Loss Per Share - Schedule of Weighted Average Potentially Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - shares |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Potentially dilutive securities | ||||
| Potentially dilutive securities | 8,753,013 | 1,939,738 | 8,527,761 | 1,831,130 |
| Stock issuable upon exercise of warrants | ||||
| Potentially dilutive securities | ||||
| Potentially dilutive securities | 3,999,999 | 0 | 3,999,999 | 0 |
| Stock issuable upon conversion of convertible note | ||||
| Potentially dilutive securities | ||||
| Potentially dilutive securities | 4,118,181 | 1,463,415 | 4,118,181 | 1,463,415 |
| Stock options to purchase common stock | ||||
| Potentially dilutive securities | ||||
| Potentially dilutive securities | 166 | 0 | 1,041 | 166 |
| Unvested RSUs | ||||
| Potentially dilutive securities | ||||
| Potentially dilutive securities | 634,667 | 476,323 | 408,540 | 367,550 |
Income Taxes (Details) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
|
| Income Tax Disclosure [Abstract] | ||||
| Tax expense | $ 0 | $ 0 | $ 0 | $ 0 |