Sientra, Inc. - Quarter Report: 2022 September (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 001-36709

SIENTRA, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

(State or Other Jurisdiction of

Incorporation or Organization)

20-5551000

(I.R.S. Employer

Identification No.)

420 South Fairview Avenue, Suite 200

Santa Barbara, California

(Address of Principal Executive Offices)

93117

(Zip Code)

(805) 562-3500

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.01 per share

SIEN

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 10, 2022, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was 100,995,909.

SIENTRA, INC.

FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2022

TABLE OF CONTENTS


		Page

Part I — Financial Information		3

Item 1. Condensed Consolidated Financial Statements - Unaudited		3
Condensed Consolidated Balance Sheets		3
Condensed Consolidated Statements of Operations		4
Condensed Consolidated Statements of Stockholders' Equity (Deficit)		5
Condensed Consolidated Statements of Cash Flows		6
Notes to the Condensed Consolidated Financial Statements		7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		27
Item 3. Quantitative and Qualitative Disclosures About Market Risk		37
Item 4. Controls and Procedures		37

Part II — Other Information		38

Item 1. Legal Proceedings		38
Item 1A. Risk Factors		38
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds		41
Item 3. Defaults Upon Senior Securities		41
Item 4. Mine Safety Disclosures		41
Item 5. Other Information		41
Item 6. Exhibits		42

“Sientra”, “Sientra Platinum20”, “Sientra Full Circle”, “Sientra Smooth”, “Sientra Teardrop”, “Allox”, “Allox2”, “Anatomical Controlled”, “BIOCORNEUM”, “Curve”, “Dermaspan”, “Luxe”, “Softspan”, “Silishield”, “AuraGen”, “AuraGen 1-2-3”, “AuraSorb” and “AuraClens” are trademarks of our company. Our logo and our other trade names, trademarks and service marks appearing in this document are our property. Other trade names, trademarks and service marks appearing in this document are the property of their respective owners. Solely for convenience, our trademarks and trade names referred to in this document appear without the TM or the (R) symbol, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the rights of the applicable licensor to these trademarks and trade names.

PART I — FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

SIENTRA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except per share and share amounts)

(Unaudited)


	September 30,			December 31,
	2022			2021
Assets
Current assets:
Cash and cash equivalents	$	18,975		$	51,772
Accounts receivable, net of allowance for doubtful accounts of $2,741 and $2,278 at September 30, 2022 and December 31, 2021, respectively		34,360			33,105
Inventories, net		51,640			52,914
Prepaid expenses and other current assets		3,557			2,979
Current assets of discontinued operations		4			4
Total current assets		108,536			140,774
Property and equipment, net		14,059			13,998
Goodwill		9,202			9,202
Other intangible assets, net		26,361			28,765
Right of use assets, net		6,894			6,565
Other assets		881			600
Total assets	$	165,933		$	199,904
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Current portion of long-term debt		—		$	2,237
Accounts payable		7,352			7,402
Accrued and other current liabilities		18,320			21,298
Customer deposits		43,013			35,182
Sales return liability		12,016			13,399
Current liabilities of discontinued operations		500			500
Total current liabilities		81,201			80,018
Long-term debt		70,064			62,434
Deferred and contingent consideration		5,837			5,872
Warranty reserve		2,675			2,505
Lease liabilities		6,999			5,604
Other liabilities		3,488			2,614
Total liabilities		170,264			159,047
Commitments and contingencies (Note 11)
Stockholders’ (deficit) equity:
Preferred stock, $0.01 par value – Authorized 10,000,000 shares; none issued or outstanding		—			—
Common stock, $0.01 par value — Authorized 200,000,000 shares; issued 63,054,802 and 62,242,090 and outstanding 62,982,075 and 62,169,363 shares at September 30, 2022 and December 31, 2021, respectively		630			622
Additional paid-in capital		667,969			661,839
Treasury stock, at cost (72,727 shares at September 30, 2022 and December 31, 2021)		(260	)		(260	)
Accumulated deficit		(672,670	)		(621,344	)
Total stockholders’ (deficit) equity		(4,331	)		40,857
Total liabilities and stockholders’ (deficit) equity	$	165,933		$	199,904

See accompanying notes to unaudited condensed consolidated financial statements.

SIENTRA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share and share amounts)

(Unaudited)


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2022			2021			2022			2021
Net sales	$	22,570		$	19,620		$	65,481		$	58,035
Cost of goods sold		9,794			9,030			27,118			26,027
Gross profit		12,776			10,590			38,363			32,008
Operating expenses:
Sales and marketing		12,290			12,052			41,542			34,348
Research and development		3,720			2,367			9,823			6,962
General and administrative		9,324			7,865			31,589			23,321
Total operating expenses		25,334			22,284			82,954			64,631
Loss from operations		(12,558	)		(11,694	)		(44,591	)		(32,623	)
Other (expense) income, net:
Interest income		41			1			58			4
Interest expense		(2,364	)		(2,026	)		(6,584	)		(6,143	)
Change in fair value of derivative liability		—			35,550			—			(14,460	)
Other (expense) income, net		(6	)		6,672			(1	)		6,575
Total other (expense) income, net		(2,329	)		40,197			(6,527	)		(14,024	)
(Loss) Income from continuing operations before income taxes		(14,887	)		28,503			(51,118	)		(46,647	)
Income tax expense		—			—			—			—
(Loss) Income from continuing operations		(14,887	)		28,503			(51,118	)		(46,647	)
(Loss) Income from discontinued operations, net of income taxes		(94	)		(93	)		(208	)		233
Net (loss) income	$	(14,981	)	$	28,410		$	(51,326	)	$	(46,414	)
Basic (loss) earnings per share:
Continuing operations	$	(0.24	)	$	0.49		$	(0.82	)	$	(0.82	)
Discontinued operations		(0.00	)		0.00			(0.00	)		0.00
Basic (loss) earnings per share	$	(0.24	)	$	0.49		$	(0.82	)	$	(0.82	)
Diluted loss per share:
Continuing operations	$	(0.24	)	$	(0.08	)	$	(0.82	)	$	(0.82	)
Discontinued operations		(0.00	)		(0.00	)		(0.00	)		(0.00	)
Diluted loss per share	$	(0.24	)	$	(0.08	)	$	(0.82	)	$	(0.82	)
Weighted average outstanding common shares used for net (loss) income per share attributable to common stockholders:
Basic		62,848,172			58,005,784			62,613,501			56,680,594
Diluted		62,848,172			72,639,930			62,613,501			56,680,594

See accompanying notes to unaudited condensed consolidated financial statements.

SIENTRA, INC.

Condensed Consolidated Statements of Stockholders' Equity (Deficit)

(In thousands, except share amounts)

(Unaudited)


																Additional						Total
	Preferred stock				Common stock						Treasury stock					paid-in			Accumulated			stockholders'
	Shares		Amount		Shares			Amount			Shares		Amount			capital			deficit			equity
Balances at December 31, 2020		—	$	—		50,712,151		$	506			72,727	$	(260	)	$	558,059		$	(558,862	)	$	(557	)
Proceeds from follow-on offering, net of costs		—		—		6,222,222			62			—		—			39,164			—			39,226
Stock-based compensation		—		—		—			—			—		—			3,163			—			3,163
Stock option exercises		—		—		12,727			—			—		—			51			—			51
Employee stock purchase program (ESPP)		—		—		95,919			1			—		—			322			—			323
Vested restricted stock		—		—		554,896			6			—		—			752			—			758
Shares withheld for tax obligations on vested RSUs		—		—		(82,830	)		(1	)		—		—			(1,214	)		—			(1,215	)
Net loss		—		—		—			—			—		—			—			(54,690	)		(54,690	)
Balances at March 31, 2021		—	$	—		57,515,085		$	574			72,727	$	(260	)	$	600,297		$	(613,552	)	$	(12,941	)
Stock-based compensation		—		—		—			—			—		—			2,584			—			2,584
Stock option exercises		—		—		23,636			1			—		—			94			—			95
Vested restricted stock		—		—		471,759			5			—		—			242			—			247
Shares withheld for tax obligations on vested RSUs		—		—		(81,386	)		(1	)		—		—			(726	)		—			(727	)
Net loss		—		—		—			—			—		—			—			(20,134	)		(20,134	)
Balances at June 30, 2021		—	$	—		57,929,094		$	579			72,727	$	(260	)	$	602,491		$	(633,686	)	$	(30,876	)
Stock-based compensation		—		—		—			—			—		—			2,326			—			2,326
Employee stock purchase program (ESPP)		—		—		103,152			1			—		—			349			—			350
Vested restricted stock		—		—		148,098			1			—		—			(1	)		—			—
Shares withheld for tax obligations on vested RSUs		—		—		(50,755	)		—			—		—			(478	)		—			(478	)
Reclassification of derivative liability to equity		—		—		—			—			—		—			41,030			—			41,030
Net Income		—		—		—			—			—		—			—			28,410			28,410
Balances at September 30, 2021		—	$	—		58,129,589		$	581			72,727	$	(260	)	$	645,717		$	(605,276	)	$	40,762

																Additional						Total
	Preferred stock				Common stock						Treasury stock					paid-in			Accumulated			stockholders'
	Shares		Amount		Shares			Amount			Shares		Amount			capital			deficit			equity (Deficit)
Balances at December 31, 2021		—	$	—		62,242,090		$	622			72,727	$	(260	)	$	661,839		$	(621,344	)	$	40,857
Stock-based compensation		—		—		—			—			—		—			2,196			—			2,196
Employee stock purchase program (ESPP)		—		—		139,574			1			—		—			328			—			329
Vested restricted stock		—		—		265,331			3			—		—			(3	)		—			—
Shares withheld for tax obligations on vested RSUs		—		—		(94,068	)		(1	)		—		—			(254	)		—			(255	)
Net loss		—		—		—			—			—		—			—			(18,041	)		(18,041	)
Balances at March 31, 2022		—	$	—		62,552,927		$	625			72,727	$	(260	)	$	664,106		$	(639,385	)	$	25,086
Stock-based compensation		—		—		—			—			—		—			2,062			—			2,062
Vested restricted stock		—		—		330,770			3			—		—			(3	)		—			—
Shares withheld for tax obligations on vested RSUs		—		—		(87,493	)		(1	)		—		—			(174	)		—			(175	)
Net loss		—		—		—			—			—		—			—			(18,304	)		(18,304	)
Balances at June 30, 2022		—	$	—		62,796,204		$	627			72,727	$	(260	)	$	665,991		$	(657,689	)	$	8,669
Stock-based compensation		—		—		—			—			—		—			1,855			—			1,855
Employee stock purchase program (ESPP)		—		—		203,131			2			—		—			142			—			144
Vested restricted stock		—		—		76,019			1			—		—			(1	)		—			—
Shares withheld for tax obligations on vested RSUs		—		—		(20,552	)		—			—		—			(18	)		—			(18	)
Net loss		—		—		—			—			—		—			—			(14,981	)		(14,981	)
Balances at September 30, 2022		—	$	—		63,054,802		$	630			72,727	$	(260	)	$	667,969		$	(672,670	)	$	(4,331	)

See accompanying notes to unaudited condensed consolidated financial statements.

SIENTRA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)


	Nine Months Ended September 30,
	2022			2021
Cash flows from operating activities:
Net loss	$	(51,326	)	$	(46,414	)
(Loss) income from discontinued operations, net of income taxes		(208	)		233
Loss from continuing operations, net of income taxes		(51,118	)		(46,647	)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization		4,947			3,149
Provision for doubtful accounts		1,086			875
Provision for warranties		583			684
Provision for inventory		607			638
Fair value adjustments to derivative liability		—			14,460
Fair value adjustments of other liabilities held at fair value		(88	)		49
Amortization of debt discount and issuance costs		3,029			2,632
Gain on extinguishment of debt		—			(6,652	)
Stock-based compensation expense		6,113			8,073
Payments of contingent consideration liability in excess of acquisition-date fair value		—			(2,419	)
Other non-cash adjustments		135			584
Changes in operating assets and liabilities:
Accounts receivable		(2,341	)		(7,558	)
Inventories		667			(12,999	)
Prepaid expenses, other current assets and other assets		1,997			(205	)
Accounts payable, accrued, and other liabilities		(5,514	)		1,279
Customer deposits		7,830			12,381
Sales return liability		(1,383	)		3,113
Net cash flow used in operating activities - continuing operations		(33,450	)		(28,563	)
Net cash flow used in operating activities - discontinued operations		(208	)		(989	)
Net cash used in operating activities		(33,658	)		(29,552	)
Cash flows from investing activities:
Purchase of property and equipment		(1,856	)		(4,882	)
Net cash flow used in investing activities - continuing operations		(1,856	)		(4,882	)
Net cash flow used in investing activities - discontinued operations		—			11,314
Net cash (used in) provided by investing activities		(1,856	)		6,432
Cash flows from financing activities:
Proceeds from issuance of common stock for employee stock-based plans		475			1,824
Net proceeds from issuance of common stock		—			39,226
Tax payments related to shares withheld for vested restricted stock units (RSUs)		(448	)		(2,420	)
Gross borrowings under the Term Loan		5,000			1,000
Gross borrowings under the Revolving Loan		5,440			—
Repayment of the Revolving Loan		(7,678	)		—
Payments of contingent consideration up to acquisition-date fair value		—			(4,550	)
Payments for debt financing fees		(73	)		(800	)
Net cash provided by financing activities		2,716			34,280
Net (decrease) increase in cash, cash equivalents and restricted cash		(32,798	)		11,160
Cash, cash equivalents and restricted cash at:
Beginning of period		52,068			55,300
End of period	$	19,270		$	66,460

Reconciliation of cash, cash equivalents, and restricted cash to the condensed consolidated balance sheets
Cash and cash equivalents		18,975			66,127
Restricted cash included in other assets		295			333
Total cash, cash equivalents and restricted cash	$	19,270		$	66,460

Supplemental disclosure of cash flow information:
Interest paid	$	3,385		$	3,133
Supplemental disclosure of non-cash investing and financing activities:
Property and equipment in accounts payable and accrued liabilities		1,242			323
Reclassification of derivative liability to equity		—			41,030
Deferred financing costs in accounts payable and accrued liabilities		250			—

See accompanying notes unaudited to condensed consolidated financial statements.

SIENTRA, INC.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

Summary of Significant Accounting Policies

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 accounting principles generally accepted in the United States of America, or GAAP, and the rules and regulations of the U.S. Securities and Exchange Commission, or SEC. Accordingly, they do not include certain footnotes and financial presentations normally required under accounting principles generally accepted in the United States of America 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, 2021 filed with the SEC on March 31, 2022, or the Annual Report. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period.

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

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 generally accepted accounting principles in the United States of America. 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.

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, 2022, the Company incurred net losses of $51.3 million and used $33.5 million of cash in continuing operations. As of September 30, 2022, the Company had cash and cash equivalents of $19.0 million. These conditions raise substantial doubt about

the Company's 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.

In an effort to alleviate these conditions, management is currently evaluating various funding alternatives to improve liquidity and may seek to raise additional capital from the sale of equity securities and incremental debt financing. 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 debt and 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. These unaudited condensed financial statements do not include any adjustments relating to the carrying amounts and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

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. The amendment provides optional expedients and exceptions for contract modifications that replace a reference rate affected by reference rate reform. The amendments are effective for all entities as of March 12, 2020 through December 31, 2022, and entities may elect to apply by Topic as of any date from the beginning of an interim period that includes or is subsequent to March 12, 2020, or prospectively from a date within an interim period that includes or is subsequent to March 12, 2020, up to the date that the financial statements are available to be issued. The Company adopted the applicable amendments within ASU 2020-04 prospectively in the second quarter of 2022 and there was no material impact on its condensed consolidated financial statements from the adoption.

Recently Issued 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 is currently evaluating the impact that adoption of the standard will have on the condensed consolidated financial statements.

Risks and Uncertainties

As an aesthetics company, surgical procedures involving the Company’s breast products are susceptible to local and national government restrictions, such as social distancing, vaccination requirements, “shelter in place” orders and business closures. In addition, some treatment facilities have reduced staffing and postponed certain non-emergency procedures in response to COVID-19 or diverted resources to treat those patients with COVID-19. The Company anticipates that the continuing shortage in staff, especially nurses, at hospitals across the U.S. due to the impact of COVID-19 may also lower number of non-emergency procedures performed. The inability or limited ability to perform such non-emergency procedures and patients electing to postpone elective aesthetics procedures due to the pandemic significantly harmed the Company’s revenues since the second quarter of 2020 and continued to harm the Company’s revenues during the nine months ended September 30, 2022. While many states have lifted certain restrictions on non-emergency procedures and procedural volume rates for non-emergency procedures have been recovering, the Company will likely continue to experience future harm to its revenues while existing or new restrictions remain in place. It is not possible to accurately predict the length or severity of the COVID-19 pandemic or the impact on the Company’s business, including the timing for a broad and sustained ability to perform non-emergency procedures involving the Company’s products. The Company continues to monitor and assess new information related to the COVID-19 pandemic, the actions taken to contain or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets.

Further, the spread of COVID-19 has caused the Company to modify workforce practices, and the Company may take further actions determined to be in the best interests of the Company’s employees or as required by governments. The continued spread of COVID-19, or another infectious disease, and other geopolitical conditions, could also result in delays or disruptions in the Company’s supply chain (for example, sourcing of medical-grade silicone) or adversely affect the Company’s manufacturing facilities and personnel. Further, trade and/or national security protection policies may be adjusted as a result of the COVID-19 pandemic, such as actions by governments that limit, restrict or prevent the movement of certain goods into a country and/or region, and current U.S./China trade relations may be further exacerbated by the pandemic.

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 pandemic. While the full impact and duration of COVID-19 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.

Reclassifications

Certain reclassifications have been made to prior year amounts to conform to the current year presentation, including those related to discontinued operations following the sale of the miraDry business.

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, 2022, 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 additional extension of six months thereafter. During the three and nine months ended September 30, 2022, the Company recognized $0.3 million and $0.8 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):


	September 30,		December 31,
	2022		2021
Assets of discontinued operations:
Prepaid expenses and other current assets	$	4	$	4
Current assets of discontinued operations		4		4
Total assets of discontinued operations	$	4	$	4
Liabilities of discontinued operations:
Accounts payable	$	6	$	6
Accrued and other current liabilities		494		494
Total liabilities of discontinued operations	$	500	$	500

The results of operations for the miraDry business were included in income (loss) from discontinued operations on the accompanying condensed consolidated statements of operations. The following table provides information regarding the results of discontinued operations (in thousands):


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2022			2021			2022			2021
Net sales	$	—		$	—		$	—		$	9,347
Cost of goods sold		—			—			—			4,805
Gross profit		—			—			—			4,542
Operating expenses		94			57			208			1,744
(Loss) income from operations of discontinued operations		(94	)		(57	)		(208	)		2,798
Other income (expense), net		—			—			—			(77	)
(loss) income from discontinued operations before income taxes		(94	)		(57	)		(208	)		2,721
Loss on sale of discontinued operations before income taxes		—			(36	)		—			(2,488	)
Total (loss) income from discontinued operations before income taxes		(94	)		(93	)		(208	)		233
Income tax expense (benefit)		—			—			—			—
(Loss) income from discontinued operations, net of income taxes	$	(94	)	$	(93	)	$	(208	)	$	233

The results of the miraDry business, including the results of operations, cashflows, and related assets and liabilities are reported as discontinued operations for all periods presented herein.

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, and BIOCORNEUM, 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 with the exception of the service-type warranty under the Platinum20

Limited Warranty Program, or Platinum20, which is based on the expected cost plus margin approach. Inputs into the expected cost plus 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, 2022 were as follows:


	Nine Months Ended September 30,
	2022
Balance as of December 31, 2021	$	3,237
Additions and adjustments		1,607
Revenue recognized		(582	)
Balance as of September 30, 2022	$	4,262
Less short-term portion		(774	)
Long-term portion	$	3,488

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 for service warranties are recognized ratably over the term of the agreements. Specifically for Platinum20, the performance obligation is satisfied at the time that the benefits are provided and are expected to be satisfied over the following 3 to 24 month period 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 of breast implants and tissue expanders 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, 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. The estimated sales returns are recorded as a reduction of revenue and as a sales return liability in the same period revenue is recognized. Actual sales returns 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. The following table provides a rollforward of the sales return liability (in thousands):


	Nine Months Ended September 30,
	2022			2021
Beginning balance	$	13,399		$	9,192
Addition to reserve for sales activity		131,281			115,374
Actual returns		(132,351	)		(110,996	)
Change in estimate of sales returns		(313	)		(1,265	)
Ending balance	$	12,016		$	12,305

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 is discussed in Note 5. The fair value of the long-term 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, 2022, the carrying value of the long-term debt was not materially different from the fair value. As of September 30, 2022, the carrying value and fair value of the convertible note were as follows (in thousands):


	September 30,		December 31,
	2022		2021
Carrying value	$	49,674	$	47,477
Fair value	$	45,383	$	42,029

Balance Sheet Components

Inventories

Inventories, net consist of the following (in thousands):


	September 30,		December 31,
	2022		2021
Raw materials	$	1,754	$	2,109
Work in progress		4,279		4,796
Finished goods		45,607		46,009
	$	51,640	$	52,914

Property and Equipment

Property and equipment, net consist of the following (in thousands):


	September 30,			December 31,
	2022			2021
Leasehold improvements	$	4,902		$	2,734
Manufacturing equipment and tooling		10,759			9,922
Computer equipment		1,700			1,672
Software		6,385			6,379
Furniture and fixtures		1,291			1,542
		25,037			22,249
Less accumulated depreciation		(10,978	)		(8,251	)
	$	14,059		$	13,998

Depreciation expense for the three months ended September 30, 2022 and 2021 was $0.6 million and $0.7 million, respectively. Depreciation expense for both the nine months ended September 30, 2022 and 2021 was $2.2 million.

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 as of September 30, 2022 and December 31, 2021 were as follows (in thousands):


	Plastic Surgery
Balances as of December 31, 2021
Goodwill		23,480
Accumulated impairment losses		(14,278	)
Goodwill, net	$	9,202
Balances as of September 30, 2022
Goodwill		23,480
Accumulated impairment losses		(14,278	)
Goodwill, net	$	9,202

The components of the Company’s other intangible assets consist of the following (in thousands):


	Average
	Amortization		September 30, 2022
	Period		Gross Carrying		Accumulated			Intangible
	(in years)		Amount		Amortization			Assets, net
Intangibles with definite lives
Customer relationships		10	$	4,940	$	(4,426	)	$	514
Trade names - finite life		12		800		(439	)		361
Manufacturing know-how		19		8,240		(2,272	)		5,968
Developed technology		8		20,954		(1,886	)		19,068
Total definite-lived intangible assets			$	34,934	$	(9,023	)	$	25,911
Intangibles with indefinite lives
Total trade names - indefinite-lived				450		—			450
Total definite and indefinite-lived intangibles			$	35,384	$	(9,023	)	$	26,361


	Average
	Amortization		December 31, 2021
	Period		Gross Carrying		Accumulated			Intangible
	(in years)		Amount		Amortization			Assets, net
Intangibles with definite lives
Customer relationships		10	$	4,940	$	(4,224	)	$	716
Trade names - finite life		12		800		(389	)		411
Manufacturing know-how		19		8,240		(1,652	)		6,588
Developed technology		8		20,600		—			20,600
Total definite-lived intangible assets			$	34,580	$	(6,265	)	$	28,315
Intangibles with indefinite lives
Total trade names - indefinite-lived				450		—			450
Total definite and indefinite-lived intangibles			$	35,030	$	(6,265	)	$	28,765

Amortization expense for the three months ended September 30, 2022 and 2021 were $0.9 million and $0.3 million, respectively. Amortization expense for the nine months ended September 30, 2022 and 2021 was $2.8 million and $0.9 million, respectively. Amortization expense related to developed technology is recorded in research and development and manufacturing know-how is recorded to cost of goods sold in the Consolidated Statements of Operations. The following table summarizes the future estimated amortization expense relating to the Company's definite-lived intangible assets as of September 30, 2022 (in thousands):


	Amortization
Period	Expense
2022	$	2,136
2023		3,552
2024		3,408
2025		3,265
2026		3,092
Thereafter		10,458
	$	25,911

Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following (in thousands):


	September 30,		December 31,
	2022		2021
Payroll and related expenses	$	1,938	$	1,975
Accrued severance		949		248
Accrued commissions		2,027		4,329
Accrued bonuses		1,824		3,213
Deferred and contingent consideration, current portion		2,867		2,431
Lease liabilities		1,705		1,666
Other		7,010		7,436
	$	18,320	$	21,298

Accrued warranties

The following table provides a rollforward of the accrued assurance-type warranties (in thousands):


	Nine Months Ended September 30,
	2022			2021
Balance as of January 1	$	2,505		$	1,934
Warranty costs incurred during the period		(413	)		(270	)
Changes in accrual related to warranties issued during the period		633			673
Changes in accrual related to pre-existing warranties		(50	)		11
Balance as of September 30	$	2,675		$	2,348

As of September 30, 2022 and 2021, both balances are included in “Warranty reserve” on the condensed consolidated balance sheets.

Fair Value Measurements

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 AuraGen 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 AuraGen is based on the achievement of certain clinical endpoints following the completion of a study measuring retention rates using the fat grafting products. The significant assumptions utilized in the fair value measurement was the probable retention rate based on historical data and the Company's equity volatility of 98%. 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 20.0%.

As these inputs are not observable, the overall fair value measurement of the contingent consideration is classified as Level 3.

The following tables present information about the Company’s liabilities that are measured at fair value on a recurring basis as of September 30, 2022 and December 31,2021 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):


	Fair Value Measurements as of
	September 30, 2022 Using:
	Level 1		Level 2		Level 3		Total
Liabilities:
Liability for contingent consideration	$	—	$	—	$	2,944	$	2,944
	$	—	$	—	$	2,944	$	2,944


	Fair Value Measurements as of
	December 31, 2021 Using:
	Level 1		Level 2		Level 3		Total
Liabilities:
Liability for contingent consideration	$	—	$	—	$	3,114	$	3,114
	$	—	$	—	$	3,114	$	3,114

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):


	Contingent consideration liability
Balance, December 31, 2021	$	3,114
Change in fair value		(170	)
Balance, September 30, 2022	$	2,944

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.

Leases

Components of lease expense were as follows:


		Three Months Ended September 30,						Nine Months Ended September 30,
Lease Cost	Classification	2022			2021			2022			2021
Operating lease cost	Operating expenses	$	578		$	405		$	1,429		$	1,239
Operating lease cost	Inventory		102			154			323			377
Sublease income	Operating expenses		(287	)		(233	)		(826	)		(301	)
Total operating lease cost		$	393		$	326		$	926		$	1,315
Finance lease cost
Amortization of right-of-use assets	Operating expenses	$	—		$	8		$	3		$	26
Amortization of right-of-use assets	Inventory		13			12			36			35
Interest on lease liabilities	Other income (expense), net		1			2			3			6
Total finance lease cost		$	14		$	22		$	42		$	67
Total lease cost		$	407		$	348		$	968		$	1,382

As mentioned above in Note 2, as part of the sale of the miraDry business the Company entered into a sublease agreement whereby the Buyer subleased the miraDry office space in Santa Clara, CA. Further, in January 2022 the Company entered into a sublease agreement to sublease a part of the office space in Santa Barbara, CA for a term of three years. For both the three and nine months ended September 30, 2022 and 2021, sublease income was recognized in general and administrative expenses in the condensed consolidated statements of operations.

Short-term lease expense for the three and nine months ended September 30, 2022 and 2021 was not material.

Supplemental cash flow information related to operating and finance leases for the nine months ended September 30, 2022 was as follows (in thousands):


	2022		2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash outflows from operating leases	$	1,277	$	1,261
Operating cash outflows from finance leases		40		56
Right-of-use assets obtained in exchange for lease obligations:
Operating leases, net of tenant improvement allowances of $1.1 million	$	1,542	$	572

Supplemental balance sheet information related to operating and finance leases was as follows (in thousands, except lease term and discount rate):


	September 30,			December 31,
	2022			2021
Reported as:
Right of use assets, net
Operating lease right-of-use assets	$	6,855		$	6,488
Finance lease right-of-use assets		39			77
Total right-of use assets	$	6,894		$	6,565
Accrued and other current liabilities
Operating lease liabilities	$	1,677		$	1,595
Finance lease liabilities		28			71
Lease liabilities
Operating lease liabilities		6,994			5,576
Finance lease liabilities		5			28
Total lease liabilities	$	8,704		$	7,270
Weighted average remaining lease term (years)
Operating leases		5			4
Finance leases		1			2
Weighted average discount rate
Operating leases		9.18	%		8.16	%
Finance leases		6.90	%		6.90	%

As of September 30, 2022, maturities of the Company’s operating and finance lease liabilities and sublease income are as follows (in thousands):


Period	Operating leases		Finance leases		Total		Sublease income
2022	$	559	$	10	$	569	$	(465	)
2023		2,628		23		2,651		(224	)
2024		2,369		1		2,370		(231	)
2025		1,467		—		1,467		(39	)
2026		1,438		—		1,438		—
2027 and thereafter		2,689		—		2,689		—
Total lease payments (receipts)	$	11,150	$	34	$	11,184	$	(959	)
Less imputed interest		2,479		1		2,480
Total lease liabilities	$	8,671	$	33	$	8,704

Debt

Term Loan and Revolving Loan

On March 30, 2022 (the “Effective Date”), the Company entered into a Third Amendment (the “Third Amendment”) to the Term Loan Agreement, with certain of the Company’s wholly owned subsidiaries, the lenders party thereto and MidCap, in order to provide the Company an additional tranche of funding and allow the Company to draw the fourth tranche. The Third Amendment provided that the fourth tranche of $5,000,000 was to be drawn on March 31, 2022. Additionally, the Third Amendment provides the Company with a sixth tranche pursuant to which the Company may draw $9,000,000 any time after January 1, 2023 until March 31, 2023. The Third Amendment also eliminated the minimum unrestricted cash requirement and reset the minimum Net Revenue (as defined therein) requirements based on the Company’s 12-month trailing Net Revenue. Finally, the Third Amendment increased the prepayment fee by 0.5% until following the third anniversary of the Effective Date, at which point no prepayment fee shall apply.

As of September 30, 2022, there was $21.0 million of outstanding principal and $0.3 million of an exit fee payable related to the term loans, reduced by unamortized debt issuance costs of $0.7 million included in "Current portion of long-term debt" and $0.2 million included in “Long-term debt” on the condensed consolidated balance sheets.

Also on March 30, 2022, the Company entered into a Sixth Amendment (the “Sixth Amendment”) to the Revolving Loan Agreement, with certain of the Company’s wholly owned subsidiaries, the lenders party thereto and MidCap. The Sixth Amendment modified the Net Revenue (as defined therein) requirement in a manner consistent with the modification under the Restated Term Loan Agreement. In addition, the Sixth Amendment made other conforming changes to the Restated Term Loan Agreement.

As of September 30, 2022, there was no amount outstanding under the Revolving Loan. As of September 30, 2022, the unamortized debt issuance costs related to the revolving loan was approximately $32,000 and was included in “Other assets” on the condensed consolidated balance sheets.

The amortization of debt issuance costs on the term loan and the revolving loan for both the three months ended September 30, 2022 and 2021 were $0.2 million and $0.1 million, respectively and was included in interest expense in the condensed consolidated statements of operations. The amortization of debt issuance costs on the term loan and the revolving loan for both the nine months ended September 30, 2022 and 2021 were $0.5 million and $0.4 million respectively, and was included in interest expense in the condensed consolidated statements of operations.

The Term Loan and Revolving Loan Agreements include customary affirmative and restrictive covenants and representations and warranties, including a financial covenant for minimum revenues, a financial covenant for minimum cash requirements, a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens, investments, distributions, collateral, mergers or acquisitions, taxes, and deposit accounts. Upon the occurrence of an event of default, a default interest rate of an additional 5.0% may be applied to any outstanding principal balances, and MidCap may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Credit Agreements. The Company’s obligations under the Credit Agreements are secured by a security interest in substantially all of the Company’s assets. See Note 12, Subsequent Events, for additional details regarding the Term Loan and Revolving Loan.

Convertible Note

As of September 30, 2022, there was $60.0 million of outstanding principal, reduced by unamortized debt discount and issuance costs of $10.3 million related to the convertible note included in “Long-term debt” on the condensed consolidated balance sheet. 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 three months ended September 30, 2022 and 2021, the amortization of the convertible debt discount and issuance costs were $0.9 million and $0.8 million, respectively. For the nine months ended September 30, 2022 and 2021, the amortization of the convertible debt discount and issuance costs were $2.5 million and $2.2 million, respectively. Both were included in interest expense in the condensed consolidated statements of operations. See Note 12, Subsequent Events, for additional details regarding the Convertible Note.

Stockholders’ Equity

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, 2022 and December 31, 2021, the Company had no preferred stock issued or outstanding.

b. Stock Option Plans

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.

As of September 30, 2022, a total of 1,808,507 shares of the Company’s common stock were available for issuance under the 2014 Plan. As of September 30, 2022, inducement grants for 3,524,922 shares of common stock have been awarded, and no shares of common stock were available for future issuance under the Inducement Plan.

Options under 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 not be 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. Additionally, options have been granted to certain key executives that vest upon achievement of performance conditions based on performance targets as defined by the board of directors, which have included net sales targets and defined corporate objectives over the performance period with possible payout ranging from 0% to 100% of the target 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:


				Weighted		Weighted average
				average		remaining
	Option			exercise		contractual
	Shares			price		term (year)
Balances at December 31, 2021		1,703,963		$	4.75		5.41
Granted		150,000
Forfeited		(77,034	)		5.05
Balances at September 30, 2022		1,776,929		$	4.34		5.27

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 the three months ended September 30, 2022 and 2021 was $0.2 million and $0.1 million, respectively. Stock-based compensation expense related to stock options for the nine months ended September 30, 2022 and 2021 was $0.5 million and $0.4 million, respectively.

c. 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:


				Weighted average
	Number			grant date
	of shares			fair value
Balances at December 31, 2021		2,799,552		$	8.11
Granted		4,601,848			1.85
Vested		(670,824	)		5.57
Forfeited		(242,363	)		-
Balances at September 30, 2022		6,488,213		$	4.23

Stock-based compensation expense for RSUs for the three months ended September 30, 2022 and 2021 was $1.5 million and $2.1 million, respectively. Stock-based compensation expense for RSUs for the nine months ended September 30, 2022 and 2021 was $5.2 million and $7.3 million, respectively. As of September 30, 2022, there was $10.5 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 1.96 years.

d. 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, 2022, employees purchased 342,705 shares of common stock at a weighted average price of $1.38 per share. As of September 30, 2022, the number of shares of common stock available for future issuance for the ESPP was 1,532,603.

The Company estimated the fair value of employee stock purchase rights using the Black-Scholes model. Stock-based compensation expense related to the ESPP was $0.1 million for both the three months ended September 30, 2022 and 2021. Stock-based compensation expense related to the ESPP was $0.4 million for both the nine months ended September 30, 2022 and 2021.

Net (Loss) Income 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.


	Three Months Ended September 30,								Nine Months Ended September 30,
	2022				2021				2022			2021
(Loss) income from continuing operations		$	(14,887	)		$	28,503		$	(51,118	)	$	(46,647	)
(Loss) Income from discontinued operations, net of income taxes			(94	)			(93	)		(208	)		233
Net (loss) income		$	(14,981	)		$	28,410		$	(51,326	)	$	(46,414	)
Expenses attributable to the convertible note		$	-			$	(34,158	)	$	-		$	-
Losses attributable to common shares		$	(14,981	)		$	(5,748	)	$	(51,326	)	$	(46,414	)
Weighted average common shares outstanding, basic			62,848,172				58,005,784			62,613,501			56,680,594
Weighted average common shares outstanding, diluted			62,848,172				72,639,930			62,613,501			56,680,594
Basic (loss) earnings per share:
Continuing operations		$	(0.24	)		$	0.49		$	(0.82	)	$	(0.82	)
Discontinued operations			(0.00	)			0.00			(0.00	)		0.00
Basic net (loss) income per share		$	(0.24	)		$	0.49		$	(0.82	)	$	(0.82	)
Diluted loss per share:
Continuing operations		$	(0.24	)		$	(0.08	)	$	(0.82	)	$	(0.82	)
Discontinued operations			(0.00	)			(0.00	)		(0.00	)		(0.00	)
Diluted net loss income per share		$	(0.24	)		$	(0.08	)	$	(0.82	)	$	(0.82	)

The Company excluded the following weighted average potentially dilutive securities, outstanding for the three and nine months ended September 30, 2022 and 2021, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2022 and 2021 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Stock issuable upon conversion of convertible note		14,634,146		—		14,634,146		14,634,146
Stock options to purchase common stock		—		1,582,901		1,659		1,629,493
Unvested RSUs		4,763,225		2,322,816		3,675,495		2,049,832
		19,397,371		3,905,717		18,311,300		18,313,471

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, 2022 and 2021.

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. A second amended complaint was filed on November 19, 2021. On December 3, 2021 the Company filed a renewed motion for demurrer as to all plaintiffs based on the recent FDA labelling updates on BIA-ALCL warnings. On January 5, 2022 the Company filed a demurrer to the second amended complaint as to plaintiff Craft and otherwise filed an Answer denying the remaining plaintiff's claims and asserting affirmative defenses. The Company's renewed demurrer as to all plaintiffs, and demurrer as to Craft is scheduled for oral argument on September 20, 2022. 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. As a result of these developments, the Company determined a probable loss had been incurred and recorded $1.6 million of legal settlement expenses within general and administrative expense in the condensed consolidated statement of operations for the nine months ended September 30, 2022.

On September 23, 2020, a lawsuit was filed in the Eastern District of Tennessee against the Company. 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 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 plaintiff filed a motion for reconsideration of the Court’s order. The Company opposed that motion on April 11, 2022.

12. Subsequent Events

Amended and Restated Facility Agreement

On October 12, 2022, the Company entered into an Amended and Restated Facility Agreement (the “Restated Agreement”) by and among the Company as borrower, certain of the Company’s subsidiaries from time to time party thereto as guarantors and Deerfield Partners, L.P., as agent and lender (“Deerfield”). The Restated Agreement amends and restates the Company’s existing Facility Agreement with Deerfield, dated March 11, 2020 (the “Existing Agreement”), pursuant to which the Company issued and sold to Deerfield an unsecured and subordinated convertible note in a principal amount of $60.0 million (the “Original Note”). In connection with the Restated Agreement, on October 12, 2022, 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 as further described below, reducing the outstanding principal amount of the Original Note to $50.0 million.

Pursuant to the Restated Agreement, the maturity date of the Original Note was extended until March 11, 2026, and the initial conversion price was reduced to $2.75, representing a 272% premium over the Company’s closing stock price of $0.7401 on October 11, 2022. 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 “New Note” and, together with the Original Note, the “Convertible Notes”). The New Note matures on the fifth anniversary of the issuance date and is convertible into shares of the Company’s common stock, par value $0.01 (the “Common Stock”), at an initial conversion price of $1.00, representing a 35% premium over the Company’s closing stock price of $0.7401 on October 11, 2022. On the payment, repayment, dischargement, redemption or prepayment of the New Note or upon a Successor Major Transaction Conversion (as defined in the New Note), the Company will pay a non-refundable exit fee equal to 1.95% of the New Note so paid, repaid, discharged, redeemed or prepaid, as the case may be. The New Note was sold in a private placement to Deerfield pursuant to an exemption for transactions by an issuer not involving a public offering under Section 4(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506(b) of Regulation D promulgated under the Securities Act (“Regulation D”). The Company made this determination based on the representations of Deerfield in the Restated Agreement, including that Deerfield is an “accredited investor” within the meaning of Rule 501 of Regulation D. In connection with the Restated Agreement and the Convertible Notes issued thereunder, all of the Company’s operating subsidiaries (each a “Guarantor” and, collectively, the “Guarantors”) entered into a Guaranty and Security Agreement, dated as of October 12, 2022 (the “Guaranty and Security Agreement”), whereby the Guarantors agreed to guarantee the obligations and liabilities of the Company under the Restated Agreement and the Convertible Notes.

The Company used the proceeds from the New 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 New Note bears interest at Term SOFR plus 5.75% per annum, payable quarterly on the last business day of each calendar quarter commencing with the calendar quarter ending December 31, 2022. The New Note is convertible at any time at the option of Deerfield, provided that Deerfield is prohibited from converting the New Note into shares of Common Stock if, upon such conversion, the Holder (together with certain affiliates and “group” members) would beneficially own more than 4.985% of the total number of shares of Common Stock then issued and outstanding. Pursuant to the New Note, 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 New 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 judgement levied against the Company and a material default by the Company under the Convertible Note. The New Note will be secured by (i) a security interest in substantially all of the assets of the Company and its subsidiaries and (ii) a pledge of the equity interests of the Company’s direct and indirect subsidiaries (the foregoing, the “Collateral”). In addition, pursuant to the Guaranty and Security Agreement the Company and the Guarantors granted a security interest in the Collateral securing the Original Note on a pari passu basis with the New Note.

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 New 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.

If issued, the Warrants and the shares of Common Stock issuable upon their exercise will be issued in a private placement pursuant to Section 3(a)(9) under the Securities Act as an exchange with existing security holders (in the case of a cashless exercise of the Warrants or, in the case of a cash exercise, Section 4(a)(2) of the Securities Act in transactions not involving a public offering).

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.

The Company is subject to a number of affirmative and restrictive covenants pursuant to the Restated Agreement, 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. In addition, the Company is required to seek stockholder approval for either a reverse split of its common stock or an increase in the number of authorized shares of Common Stock, with such split or increase to take effect by not later than December 26, 2022. If the Company does not receive approve for such a split or increase, then the Convertible Notes and Warrants, if any, will be settleable is cash and the Company will be in default under the Convertible Notes. The Restated Agreement also includes a covenant that the Company will seek to raise capital in an equity transaction of at least $20,000,000, which the Company intends to pursue following the closing of the Restated Agreement. The Company is also restricted from paying dividends or making other distributions or payments on its capital stock, subject to limited exceptions.

Exchange Agreement

On October 12, 2022, the Company entered into an Exchange Agreement with Deerfield pursuant to which Deerfield agreed to exchange $10 million of principal amount under the Original Note for 2,967,742 shares of Common Stock (the “Exchange Shares”) and a pre-funded warrant to purchase 10,543,946 shares of Common Stock (the “Exchange Warrants”), reflecting a price per share of Common Stock equal to $0.7401, the closing price on October 11, 2022. The Exchange Shares, the Exchange Warrants and the shares of Common Stock issuable upon exercise of the Exchange Warrants (the “Exchange Warrant Shares”) were issued (or, in the case of the Exchange Warrant Shares, will be issued”) in a private placement pursuant to Section 3(a)(9) under the Securities Act as an exchange with existing security holders).

The Exchange Warrants are immediately exercisable, have an exercise price of $0.0001 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.

The foregoing description of the Exchange Agreement and the Exchange Warrants does not purport to be complete and is qualified in its entirety by reference to the Exchange Agreement and the Form of Exchange Warrant, copies of each of which are filed herewith as Exhibit 10.2 and Exhibit 4.4, respectively, and incorporated herein by reference.

Registration Rights Agreement

In connection with the Restated Agreement, on October 12, 2022, the Company and Deerfield entered into an Amended and Restated Registration Rights Agreement (the “Registration Rights Agreement”), which amends and restated the existing Registration Rights Agreement entered into on March 11, 2022. Pursuant to the Registration Rights Agreement, the Company has agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a Registration Statement on Form S-3, or such other form as required to effect a registration of the Common Stock issued or issuable upon conversion of or pursuant to the Convertible Notes, the Warrants or the Exchange Warrants (the “Registrable Securities”), covering the resale of the Registrable Securities and such indeterminate number of additional shares of Common Stock as may become issuable upon conversion of or otherwise pursuant to the Registrable Securities to prevent dilution resulting from certain corporate actions. Such Registration Statement must be filed within 30 calendar days following the date of the Registration Rights Agreement. In the event the SEC does not permit all of the Registrable Securities to be included in the Registration Statement or if the Registrable Securities are not otherwise included in the Registration Statement filed pursuant to the Registration Rights Agreement, the Company has agreed to file an additional Registration Statement covering the resale of all Registrable Securities not already covered by an existing and effective Registration Statement for an offering to be made on a continuous basis pursuant to Rule 415 of the Securities Act as promptly as allowed by the SEC or the SEC Guidance provided to the Company. Following effectiveness of the Registration Statement, the Company will file a combined prospectus supplement under the Registration Statement and the Company’s existing Registration Statement on Form S-3 (No. 333-237636) registering for resale the shares issuable under the Original Note. The Registration Rights Agreement also provides for piggy-back registration, subject to the terms and conditions of the Registration Rights Agreement. The Company will also file a prospectus supplement to the Existing Registration Statement within two days following the date of the Restated Agreement to reflect the amendment to the Original Note.

U.S. Department of Justice

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 U.S. Securities and Exchange Commission (the “SEC”) has subpoenaed documents and testimony from each of the Company and its General Counsel. 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. The Company intends to cooperate with DOJ and the SEC. The Company is, at this time, unable to predict what action, if any, might be taken in the future by DOJ or the SEC as a result of the matters that are the subject of the subpoenas and investigation.

Equity Financing

On October 25, 2022, the Company completed a follow on public offering pursuant to an Underwriting Agreement (the “Underwriting Agreement”), dated October 21, 2022, with Craig-Hallum Capital Group LLC, acting as the

underwriter named therein (the “Underwriter”) pursuant to which the Company issued and sold 17,785,000 shares of the Company’s Common Stock, including 5,217,390 shares issued pursuant to the Underwriter’s exercise of its option to purchase additional shares, pre-funded warrants to purchase 22,214,990 shares of Common Stock and warrants to purchase 39,999,990 shares of Common Stock, including 5,217,390 shares issued pursuant to the Underwriter’s exercise of its option to purchase additional warrants (the “Offering”). The price to the public in the Offering was $0.38 per share of common stock and warrant and $0.37 per pre-funded warrant and warrant, before underwriting discounts and commissions. The net proceeds to the Company from the Offering was approximately $13.7 million, after deducting underwriting discounts and commissions and estimated Offering expenses payable by the Company.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2021 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations are contained in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 31, 2022, or the Annual Report. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Sientra,” “the Company,” “we,” “us” and “our” refer to Sientra, Inc. and its consolidated subsidiaries.

Forward-Looking Statements

The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning our strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management, and the impact of global economic conditions and public health crises and epidemics, such as the COVID-19 pandemic, on our business and industry. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q, the risks set forth in Part I, Item 1A, in the Annual Report, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements.

Overview

We are a medical aesthetics company uniquely focused on becoming the leader of transformative treatments and technologies focused on progressing the art of plastic surgery. We were founded to provide greater choices to board-certified plastic surgeons and patients in need of medical aesthetics products. We have developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. We sell our breast implants in the U.S. for augmentation procedures exclusively to board-certified and board-admissible plastic surgeons and tailor our customer service offerings to their specific needs, which we believe helps secure their loyalty and confidence. In 2020, we also began to sell our breast implants in Japan through a distributor partner. We sell our breast tissue expanders for reconstruction procedures predominantly to hospitals and surgery centers, and our BIOCORNEUM scar management products to plastic surgeons, dermatologists and other specialties.

We completed the sale of the miraDry business on June 10, 2021, and as a result the miraDry business met the criteria to be reported as discontinued operations. Therefore, we are 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 unaudited condensed consolidated financial statements have all been revised to reflect continuing operations only. Following the Sale, we have one operating segment in continuing operations named Plastic Surgery, formerly known as Breast Products.

Our Plastic Surgery segment focuses on sales of our breast implants, tissue expanders and scar management products. We currently sell our products in the U.S. through a direct sales organization. Our international sales channel leverages a network of distribution partners.

Recent developments

Saudi Arabia Approval

On September 20, 2022, we received approval from the Saudi Food & Drug Authority to market the Company’s line of smooth surface, High-Strength Cohesive silicone gel breast implants in the Kingdom of Saudi Arabia (KSA). Following this approval, we began commercialization in KSA through our distribution partner, Rose Aljazera.

Health Canada Approval

On March 23, 2022, we received approval from Health Canada to begin commercialization of its smooth round HSC and HSC+ silicone gel breast implants in Canada. Following this approval, we began commercialization in Canada with our distribution partner, Kai Aesthetics, Inc.

COVID-19 Pandemic

As an aesthetics company, surgical procedures involving our breast products are susceptible to local and national government restrictions, such as social distancing, vaccination requirements, “shelter in place” orders and business closures, due to the economic and logistical impacts these measures have on consumer demand as well as the practitioners’ ability to administer such procedures. Hospitals across the U.S. have experienced periodic shortages of staff and postponement of certain non-emergency procedures due to the impact of COVID-19. The inability or limited ability to perform such non-emergency procedures and patients electing to postpone elective aesthetics procedures due to the pandemic significantly harmed our revenues since the second quarter of 2020 and the effects of the pandemic continue to impact our market through the nine months ended September 30, 2022. We may continue to experience future harm to our revenues while existing or new restrictions remain in place. It is not possible to accurately predict the length or severity of the COVID-19 pandemic or the impact on our business. We continue to monitor and assess new information related to the COVID-19 pandemic, the actions taken to contain or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets.

Further, the spread of COVID-19 has caused us to modify our workforce practices, and we may take further actions that we determine are in the best interests of our employees or as required by governments. The continued spread of COVID-19, or another infectious disease, and other geopolitical conditions, could also result in delays or disruptions in our supply chain (for example, sourcing of medical-grade silicone) or adversely affect our manufacturing facilities and personnel.

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 pandemic. While the full impact and duration of COVID-19 is unknown at this time, we have 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.

Components of Operating Results

Net Sales

Our net sales include sales of silicone gel breast implants, tissue expanders, BIOCORNEUM, and sizers. We recognize revenue on breast implants and tissue expanders, net of sales discounts and estimated returns, as the customer has a standard six-month window to return purchased breast implants and tissue expanders. We defer the value of our service warranty revenue and recognize it once all performance obligations have been met.

We expect that, in the future, our net sales will fluctuate on a quarterly basis due to a variety of factors, including seasonality of breast augmentation procedures and the impact of the pandemic. We believe that aesthetic procedures are subject to seasonal fluctuation due to patients planning their procedures leading up to the summer season and in the period around the winter holiday season.

Cost of Goods Sold and Gross Margin

Cost of goods sold consists primarily of raw material, labor, overhead, and variable manufacturing costs, reserve for returns, reserve for product assurance warranties, royalty costs, excess and obsolete inventory reserves, and warehouse and other related costs.

With respect to our supplier contracts, all our products and raw materials are manufactured under contracts with fixed unit costs which can increase over time at specified amounts.

We provide an assurance and service warranty on our silicone gel breast implants. The estimated warranty costs are recorded at the time of sale. Costs related to our service warranty are recorded when expense is incurred related to meeting our performance obligations.

We expect our overall gross margin, which is calculated as net sales less cost of goods sold for a given period divided by net sales, to fluctuate in future periods primarily as a result of quantity of units sold, manufacturing price increases, the changing mix of products sold with different gross margins, warranty costs, overhead costs and targeted pricing programs.

Sales and Marketing Expenses

Our sales and marketing expenses primarily consist of salaries, bonuses, benefits, incentive compensation, stock-based compensation, consumer marketing, and travel for our sales, marketing and customer support personnel. Our sales and marketing expenses also include expenses for trade shows, our no‑charge customer shipping program and no-charge product evaluation units, and severance expenses, as well as educational and promotional activities. We expect our sales and marketing expenses to fluctuate in future periods as a result of headcount and timing of our marketing programs.

Research and Development Expenses

Our research and development, or R&D, expenses primarily consist of clinical expenses, product development costs, regulatory expenses, consulting services, outside research activities, quality control and other costs associated with the development of our products and compliance with Good Clinical Practices, or cGCP, requirements. R&D expenses also include related personnel and consultant compensation, stock‑based compensation expense and amortization expense related to developed technology. We expense R&D costs as they are incurred. We expect our R&D expenses to vary as different development projects are initiated, including improvements to our existing products, expansions of our existing product lines, new product acquisitions and our clinical studies.

General and Administrative Expenses

Our general and administrative, or G&A, expenses primarily consist of salaries, bonuses, benefits, incentive compensation and stock-based compensation for our executive, financial, legal, and administrative functions. Other G&A expenses include estimated legal settlement expenses, deferred consideration adjustments, bad debt expense, outside legal counsel and litigation expenses, independent auditors and other outside consultants, corporate insurance, facilities and information technologies expenses, and severance expenses. We expect future G&A expenses to remain consistent with the current period.

Interest Income

Interest income primarily consists of interest earned on our cash and cash equivalents and marketable securities.

Interest Expense

Interest expense primarily consists of interest expense and amortization of issuance costs associated with our Credit Agreements.

Change in Fair Value of Derivative Liability

Change in fair value of derivative reflects the non-cash change in the fair value of derivatives.

Income Taxes

Income tax expense consists of an estimate for income taxes based on the projected income tax expense for the period. We operate in several tax jurisdictions and are subject to taxes in each jurisdiction in which we conduct business. To date, we have incurred cumulative net losses and maintain a full valuation allowance on our net deferred tax assets due to the uncertainty surrounding realization of such assets.

Critical Accounting Policies and Significant Judgments and Estimates

The preparation of our unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and the revenues and expenses incurred during the reported periods. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We discussed accounting policies and assumptions that involve a higher degree of judgment and complexity in Note 1 of the “Notes to Financial Statements” in our audited financial statements included in the Annual Report. There have been no material changes to our critical accounting policies and estimates from those disclosed in the Annual Report.

Recent Accounting Pronouncements

Please refer to Note 1 of the “Notes to Financial Statements” in our audited financial statements included in the Annual Report on Form 10-K for information on recent accounting pronouncements and the expected impact on our unaudited condensed consolidated financial statements.

Results of Operations

Comparison of the Three Months Ended September 30, 2022 and 2021

The following table sets forth our results of operations for the three months ended September 30, 2022 and 2021:


	Three Months Ended
	September 30,
	2022			2021
	(In thousands)
Statement of operations data
Net sales	$	22,570		$	19,620
Cost of goods sold		9,794			9,030
Gross profit		12,776			10,590
Operating expenses
Sales and marketing		12,290			12,052
Research and development		3,720			2,367
General and administrative		9,324			7,865
Total operating expenses		25,334			22,284
Loss from operations		(12,558	)		(11,694	)
Other (expense) income, net
Interest income		41			1
Interest expense		(2,364	)		(2,026	)
Change in fair value of derivative liability		—			35,550
Other income (expense), net		(6	)		6,672
Total other income (expense), net		(2,329	)		40,197
Loss from continuing operations before income taxes		(14,887	)		28,503
Income tax expense		—			—
Loss from continuing operations		(14,887	)		28,503
Loss from discontinued operations, net of income taxes		(94	)		(93	)
Net loss	$	(14,981	)	$	28,410

Net Sales

Net sales increased approximately $3.0 million, or 15.0%, to $22.6 million for the three months ended September 30, 2022 as compared to $19.6 million for the three months ended September 30, 2021. The increase was primarily due to an increase in the volume of domestic and international sales of gel implants and expanders.

Cost of Goods Sold and Gross Margin

Cost of goods sold increased approximately $0.8 million, or 8.5%, to $9.8 million for the three months ended September 30, 2022 as compared to $9.0 million for the three months ended September 30, 2021. The increase was primarily due to an increase in the volume of domestic and international sales of gel implants and expanders, offset by reductions in period distribution and production costs.

The gross margins for the three months ended September 30, 2022 and 2021 were approximately 56.6% and 54.0%, respectively. The increase was primarily due to a decrease in period distribution and production costs.

Sales and Marketing Expenses

Sales and marketing expenses increased approximately $0.2 million, or 2.0%, to $12.3 million for the three months ended September 30, 2022 as compared to $12.1 million for the three months ended September 30, 2021. The increase was primarily due to increases in employee payroll related expenses, travel expenses, and marketing initiatives, slightly offset by a decrease in shipping expenses.

Research and Development Expenses

R&D expenses increased approximately $1.4 million, or 57.2%, to $3.7 million for the three months ended September 30, 2022 as compared to $2.4 million for the three months ended September 30, 2021. The increase was primarily due to increases in costs related to clinical and regulatory activities, and product development expense.

General and Administrative Expenses

G&A expenses increased approximately $1.5 million, or 18.6%, to $9.3 million for the three months ended September 30, 2022 as compared to $7.9 million for the three months ended September 30, 2021. The increase was primarily due to increases in consulting expense, depreciation and amortization expense, and employee related expense, offset by decreases in stock compensation expense.

Other Income (Expense), net

Other income (expense), net for the three months ended September 30, 2022 decreased as compared to the three months ended September 30, 2021 primarily due to a change in the fair value of the derivative liability in the prior period which did not reoccur in the current period, after its reclassification to equity following the amendment in September 2021.

Income Tax Expense

For the three months ended September 30, 2022 and 2021 there was no income tax expense.

Loss from discontinued operations

Loss from discontinued operations for the three months ended September 30, 2022 was relatively unchanged period over period. Loss of discontinued operations is mainly due to the sale of the miraDry business during the second quarter of fiscal year 2021.

Comparison of the Nine Months Ended September 30, 2022 and 2021

The following table sets forth our results of operations for the nine months ended September 30, 2022 and 2021:


	Nine Months Ended
	September 30,
	2022			2021
	(In thousands)
Statement of operations data
Net sales	$	65,481		$	58,035
Cost of goods sold		27,118			26,027
Gross profit		38,363			32,008
Operating expenses
Sales and marketing		41,542			34,348
Research and development		9,823			6,962
General and administrative		31,589			23,321
Total operating expenses		82,954			64,631
Loss from operations		(44,591	)		(32,623	)
Other (expense) income, net
Interest income		58			4
Interest expense		(6,584	)		(6,143	)
Change in fair value of derivative liability		—			(14,460	)
Other (expense) income, net		(1	)		6,575
Total other (expense) income, net		(6,527	)		(14,024	)
Loss from continuing operations before income taxes		(51,118	)		(46,647	)
Income tax expense		—			—
(Loss) Income from continuing operations		(51,118	)		(46,647	)
(Loss) Income from discontinued operations, net of income taxes		(208	)		233
Net loss	$	(51,326	)	$	(46,414	)

Net Sales

Net sales increased approximately $7.4 million, or 12.8%, to $65.5 million for the nine months ended September 30, 2022 as compared to $58.0 million for the nine months ended September 30, 2021. The increase was primarily due to an increase in the volume of domestic sales of gel implants and expanders.

Cost of Goods Sold and Gross Margin

Cost of goods sold increased approximately $1.1 million, or 4.2% to $27.1 million for the nine months ended September 30, 2022 as compared to $26.0 million for the nine months ended September 30, 2021. The increase was primarily due to an increase in the volume of domestic and international sales of gel implants and expanders, offset by reductions in period distribution and production costs.

The gross margins for the nine months ended September 30, 2022 and 2021 were 58.6% and 55.2%, respectively. The increase was primarily due to a decrease in the unit cost of gel implants combined with a decrease in period distribution and production costs.

Sales and Marketing Expenses

Sales and marketing expenses increased approximately $7.2 million, or 20.9%, to $41.5 million for the nine months ended September 30, 2022 as compared to $34.3 million for the nine months ended September 30, 2021. The increase was primarily due to increases in employee payroll related expenses, increased marketing initiatives, shipping expenses associated with the increased volume of sales of products, severance expense, and travel expenses.

Research and Development Expenses

R&D expenses increased approximately $2.9 million, or 41.1%, to $9.8 million for the nine months ended September 30, 2022 as compared to $7.0 million for the nine months ended September 30, 2021. The increase was primarily due to increases in costs related to clinical and regulatory activities, and product development expense.

General and Administrative Expenses

G&A expenses increased approximately $8.3 million, or 35.5%, to $31.6 million for the nine months ended September 30, 2022 as compared to $23.3 million for the nine months ended September 30, 2021. The increase was primarily due to increases in depreciation and amortization expense, consulting expense, employee related expenses, legal settlement fees, expenses associated with our information technology systems subsequent to their implementation, including training and data conversion costs, and severance expense, offset by a decrease in stock compensation expense.

Other Income (Expense), net

Other income (expense), net for the nine months ended September 30, 2022 decreased as compared to the nine months ended September 30, 2021 primarily due to a change in the fair value of the derivative liability in the prior period which did not reoccur in the current period, after its reclassification to equity following the amendment in September 2021.

Income Tax Expense

For the nine months ended September 30, 2022 and 2021 there was no income tax expense.

Income (loss) from discontinued operations

Loss from discontinued operations for the nine months ended September 30, 2022 increased $0.4 million due to the sale of the miraDry business during the second quarter of fiscal year 2021.

Liquidity and Capital Resources

Since our inception, we have incurred recurring losses and cash outflows from operations and anticipate that losses will continue in the near term. During the nine months ended September 30, 2022, we incurred net losses of $51.3 and used $33.5 million of cash in continuing operations. As of September 30, 2022, we had cash and cash equivalents of $19.0 million. These conditions raise substantial doubt 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.

In an effort to alleviate these conditions, management is currently evaluating various funding alternatives to improve liquidity and may seek to raise additional capital from the sale of equity securities and incremental debt financing. On October 25, 2022, the Company completed a follow on public offering pursuant to an Underwriting Agreement (the “Underwriting Agreement”), dated October 21, 2022, with Craig-Hallum Capital Group LLC, acting as the underwriter named therein (the “Underwriter”) pursuant to which the Company issued and sold 17,785,000 shares of the Company’s Common Stock, including 5,217,390 shares issued pursuant to the Underwriter’s exercise of its option to purchase additional shares, pre-funded warrants to purchase 22,214,990 shares of Common Stock and warrants to purchase 39,999,990 shares of Common Stock, including 5,217,390 shares issued pursuant to the Underwriter’s exercise of its option to purchase additional warrants (the “Offering”). The price to the public in the Offering was

$0.38 per share of common stock and warrant and $0.37 per pre-funded warrant and warrant, before underwriting discounts and commissions. The net proceeds to the Company from the Offering was approximately $13.7 million, after deducting underwriting discounts and commissions and estimated Offering expenses payable by the Company.

As we seek additional sources of financing, there can be no assurance that such financing would be available to us on favorable terms or at all. Our ability to obtain additional financing in the debt and equity capital markets is subject to several factors, including market and economic conditions, our performance and investor sentiment with respect to us and our industry. These unaudited condensed financial statements do not include any adjustments relating to the carrying amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. See Note 12, Subsequent Events, for additional details regarding the Term Loan and Revolving Loan.

Debt financing – recent developments

Refer to Note 7 and Note 12, Subsequent events to the condensed consolidated financial statements for a full description and updates to all of our long-term debt, revolving line of credit, and convertible note.

Cash Flows

The following table shows a summary of our cash flows (used in) provided by operating, investing and financing activities from continuing operations, as well as from discontinued operations for the periods indicated (in thousands):


	Nine Months Ended September 30,
	2022			2021
Net cash (used in) provided by:
Operating activities - continuing operations	$	(33,450	)	$	(28,563	)
Investing activities - continuing operations		(1,856	)		(4,882	)
Financing activities - continuing operations		2,716			34,280
Net change in cash, cash equivalents and restricted cash from continuing operations		(32,590	)		835
Net cash provided by (used in) discontinued operations		(208	)		10,325
Net change in cash, cash equivalents and restricted cash	$	(32,798	)	$	11,160

Cash flow from operating activities of continuing operations

Net cash used in operating activities was $33.5 million during the nine months ended September 30, 2022 as compared to $28.6 million during the nine months ended September 30, 2021. The increase in cash used in operating activities between the nine months ended September 30, 2022 and 2021 was the result of the increase in net loss from continuing operations. Increase in use of cash was offset by favorable working capital improvements mostly due to inventory initiatives to decrease inventory levels and align production with demand.

Cash flow from investing activities of continuing operations

Net cash used in investing activities was $1.9 million during the nine months ended September 30, 2022 as compared to $4.9 million used during the nine months ended September 30, 2021. The decrease in cash used in investing activities was due to a decrease in cash outflows associated with our information technology system implementation in the prior period which did not reoccur in the current period.

Cash flow from financing activities of continuing operations

Net cash provided by financing activities was $2.7 million during the nine months ended September 30, 2022 as compared to $34.3 million during the nine months ended September 30,2021. The decrease in cash provided by financing activities was primarily due to an increase in proceeds from issuance of common stock in the prior period which did not reoccur in the current period and repayment of the Revolving Loan in the current year which was mostly offset by borrowings under the Term Loan and Revolving Loan.

Cash flow from discontinued operations

Net cash used by discontinued operations was $0.2 million during the nine months ended September 30, 2022 as compared to $10.3 million provided during the nine months ended September 30, 2021. The change in cash flows was primarily driven by the prior period an increase in cash provided by investing activities resulting from the proceeds of the sale of the miraDry which did not reoccur in the current period.

Our liquidity position and capital requirements are subject to a number of factors. For example, our cash inflow and outflow may be impacted by the following:

•

the ability of our implant manufacturing facility in Franklin, Wisconsin, to meet capacity to meet customer requirements and maintain unit costs that will drive gross margin;

•

the ability of our third-party tissue expander manufacturing facility operated by SiMatrix to meet capacity to meet customer requirements;

•

net sales generated and any other future products that we may develop and commercialize;

•

the scope and duration of the COVID-19 pandemic and its effect on our operations;

•

costs associated with expanding our sales force and marketing programs;

•

cost associated with developing and commercializing our proposed products or technologies;

•

expenses we incur in connection with potential litigation or governmental investigations;

•

cost of obtaining and maintaining regulatory clearance or approval for our current or future products;

•

cost of ongoing compliance with regulatory requirements, including compliance with Sarbanes-Oxley;

•

anticipated or unanticipated capital expenditures; and

•

unanticipated G&A expenses.

Our primary short-term capital needs, which are subject to change, include expenditures related to:

•

support of our sales and marketing efforts related to our current and future products;

•

new product acquisition and development efforts;

•

facilities expansion needs; and

•

investment in inventory required to meet customer demands.

Although we believe the foregoing items reflect our most likely uses of cash in the short-term, we cannot predict with certainty all of our particular short-term cash uses or the timing or amount of cash used. If cash generated from operations is insufficient to satisfy our working capital and capital expenditure requirements, we may be required to sell additional equity or debt securities or obtain credit facilities. Additional capital, if needed, may not be available on satisfactory terms, if at all. Furthermore, any additional equity financing may be dilutive to stockholders, and debt financing, if available, may include restrictive covenants. For a discussion of other factors that may impact our future liquidity and capital funding requirements, see “Risk Factors — Risks Related to Our Financial Results” in our Annual Report on Form 10-K.

Off-Balance Sheet Arrangements

During the periods presented we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.

ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Under SEC rules and regulations, as a smaller reporting company we are not required to provide the information required by this item.

ITEM 4: CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. GAAP. We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, as appropriate, to allow timely decisions regarding required disclosure.

As of September 30, 2022, we carried out an evaluation, under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, the CEO and CFO concluded that the Company’s disclosure controls and procedures were effective as of such date.

Changes in Internal Control over Financial Reporting

There have been no changes in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

From time to time, we are involved in legal proceedings and regulatory proceedings arising out of our operations. We establish reserves for specific liabilities in connection with legal actions that we deem to be probable and estimable. The ability to predict the ultimate outcome of such matters involves judgments, estimates, and inherent uncertainties. The actual outcome of such matters could differ materially from management’s estimates. Information regarding certain legal proceedings is provided in this Quarterly Report in Note 11 of the condensed consolidated financial statements.

ITEM 1A. RISK FACTORS

Except as set forth below, there have been no material changes from the risk factors disclosed in Part I, Item 1A, of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which are incorporated herein by reference.

Contracting with any third-party manufacturer and supplier involves inherent risks and various factors outside our direct control that may adversely affect the manufacturing and supply of our products.

Our reliance on any third-party manufacturer, including NuSil, which supplies our silicone materials, Formulated Solutions, LLC, or Formulated Solutions, which supplies our BIOCORNEUM scar management products, SiMatrix, a Vesta subsidiary that supplies our tissue expanders or any other third-party manufacturer we procure and qualify for the manufacture of our breast products involves a number of risks. Changes that our manufacturers may make outside the purview of our direct control, or other mistakes and mishandling of our products, can have an impact on our processes and quality, as well as the successful delivery of our products. Additionally, if any third-party manufacturer becomes unable or unwilling to supply our products, we may not be able to find an alternate supplier in a timely manner. For example, there are only a few suppliers of medical-grade silicone available, and if these suppliers become unable or unwilling to supply medical-grade silicone to Formulated Solutions, SiMatrix or any other manufacturer that we may engage with, an alternate supply of medical-grade silicone may not be able to be found in a timely manner.

Additionally, recent events may result in a global supply shortage of medical-grade silicone. In December 2021, the United States adopted the Uyghur Forced Labor Prevention Act (“UFLPA”) which creates a rebuttable presumption that any goods, wares, articles, and merchandise mined, produced, or manufactured in whole or in part in the Xinjiang Uyghur Administrative Region of China or that are produced by certain entities are prohibited from importation into the United States and are not entitled to entry. These import restrictions came into effect on June 21, 2022. Further, in early 2022, in response to actions taken by the Russia against Ukraine, the United States and other countries around the world undertook rapidly evolving and escalating campaigns targeting Russia and Belarus, and Russian and Belarussian entities and persons, with significant new economic sanctions designations and embargoes, financial restrictions, trade controls and other government restrictions. These regions make up a large portion of the global supply of medical-grade silicone. While we are not presently aware of any direct impacts these restrictions have had on our suppliers’ supply chains, disruptions resulting from the conflict in Ukraine and the UFLPA may materially and negatively impact our suppliers’ ability to obtain a sufficient supply of medical-grade silicone necessary to meet the quantity and/or timing of our product demands.

Our existing manufacturing contracts will also expire, and there can be no assurance that our contracting counterparties will agree to continue to manufacture and supply our products or they may impose increased pricing terms if the contract is renegotiated or renewed.

Some of the additional risks with relying on third-party manufacturers and suppliers include:

•

our products may not be manufactured in accordance with agreed upon specifications or in compliance with regulatory requirements or cGMP, or the manufacturing facilities may not be able to maintain compliance with regulatory requirements or cGMP, which could negatively affect the safety or efficacy of our products or cause delays in shipments of our products;

•

we may not be able to timely respond to unanticipated changes in customer orders, and if orders do not match forecasts, we may have excess or inadequate inventory of materials and components;

•

our products may be mishandled while in production or in preparation for transit;

•

we are subject to transportation and import and export risk, particularly given the global nature of our supply chain;

•

the third-party manufacturer may discontinue manufacturing and supplying products to us for risk management reasons;

•

the third-party manufacturer may lose access to critical services and components, resulting in an interruption in the manufacturing or shipment of our products;

•

the third-party manufacturer may encounter financial or other hardships unrelated to us and our demand for products, which could inhibit our ability to fulfill our orders;

•

there may be delays in analytical results or failure of analytical techniques that we depend on for quality control and release of products;

•

natural disasters, disease pandemics impacting the supply chain (such as the recent Coronavirus outbreak), wars or other conflicts (including the ongoing conflict in the Ukraine), labor disputes, financial distress, lack of raw material supply, issues with facilities and equipment or other forms of disruption to business operations affecting our manufacturer or its suppliers may occur;

•

latent defects may become apparent after products have been released and which may result in a recall of such products; and

•

there are inherent risks if we contract with manufacturers located outside of the United States, including the risks of economic change, recession, labor strikes or disruptions, political turmoil, new or changing tariffs or trade barriers, new or different restrictions on importing or exporting, civil unrest, infrastructure failure, cultural differences in doing business, lack of contract enforceability, lack of protection for intellectual property, war and terrorism.

The materialization of any of these risks and limitations inherent in a third-party manufacturing contractual relationship could significantly increase our costs, impair our ability to generate net sales, and adversely affect market acceptance of our products and customers may instead purchase or use our competitors’ products, which could materially adversely and severely affect our business, financial condition and results of operations.

There are numerous risks in relying on sole suppliers to manufacture our products, which, individually or in the aggregate, could have a material adverse and severe effect on our business, financial condition and results of operations.

We may be unable to obtain stockholder approval for a reverse stock split or increase in our authorized shares of common stock as required by the Restated Facility Agreement.

The Restated Facility Agreement requires, among other things, that we use our reasonable best efforts to obtain stockholder approval for either a reverse split of its common stock or an increase in the number of authorized shares of Common Stock as soon as possible but in any event by not later than December 26, 2022. If we are unable to obtain stockholder approval for such increase or reverse split by April 12, 2023, we will be in default under the Restated Facility Agreement and Deerfield will be entitled to the rights and remedies thereunder including, but not limited to, declaring all amounts owed under the Restated Facility Agreement immediately due and payable. If we are unable to pay those amounts if and when owed, Deerfield could proceed against the collateral granted to it pursuant to the Restated Facility Agreement. Further, if we are unable to repay our indebtedness and Deerfield institutes foreclosure proceedings against our assets, we could be forced into bankruptcy or liquidation and equity holders may lose the entire value of their investment. In any such bankruptcy or liquidation scenario, the value that we receive for our assets could be significantly lower than the values reflected in our financial statements.

We are not in compliance with the continued listing requirements of Nasdaq and may be subject to delisting.

Our common stock is currently listed for trading on the Nasdaq Global Select Market under the symbol “SIEN.” The continued listing of our common stock on Nasdaq is subject to our compliance with a number of listing standards. On September 29, 2022, we received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC, or Nasdaq, indicating that for the last 30 consecutive business days, the closing bid price of our common stock was below $1.00 per share, which is the minimum required closing bid price for continued listing on the Nasdaq Global Select Market pursuant to Listing Rule 5450(a)(1). We have 180 calendar days, or until March 28, 2023, to regain compliance. To regain compliance, the closing bid price of our common stock must be at least $1.00 per share for a minimum of ten consecutive business days. There can be no assurance that we will be able to regain compliance with these requirements or that our common stock will continue to be listed on Nasdaq.

If we are unable to regain compliance by March 28, 2023, we may be eligible for an additional 180 calendar day compliance period if it elects (and meets the listing standards) to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required, among other things, to meet the continued listing requirement for market value of publicly held shares as well as all other standards for initial listing on The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. There can be no assurance that, if we were to effect a reverse stock split after obtaining the required approvals and intending to regain compliance, the reverse stock split would cause our common stock to meet the bid price requirement. If we fail to regain compliance with the Nasdaq continued listing standards, Nasdaq will provide notice that our common stock will be subject to delisting.

Such a delisting or even notification of failure to comply with such requirements would have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In addition, the delisting of our common stock could lead to a number of other negative implications such as a loss of media and analyst coverage, a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and likely result in a reduced level of trading activity in the secondary trading market for our securities, and materially adversely impact our ability to raise capital on acceptable terms or at all. Delisting from Nasdaq could also have other negative results, including the potential loss of confidence by our current or prospective third-party providers and collaboration partners, the loss of institutional investor interest, and fewer licensing and partnering opportunities. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

If our common stock were no longer listed on Nasdaq, investors might only be able to trade on one of the over-the-counter markets. There is no assurance, however, that prices for our common stock would be quoted on one of these other trading systems or that an active trading market for our common stock would exist, which would materially and adversely impact the market value of our common stock and your ability to sell our common stock.

We received subpoenas by the Department of Justice and the SEC Division of Enforcement relating to the trading in our securities, which may require us to expend significant financial and legal resources. The resolution of those investigations may have a material adverse effect on our business, financial condition, results of operations and cash flows.

We 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 U.S. Securities and Exchange Commission (the “SEC”) has subpoenaed documents and testimony from each of the Company and our General Counsel. 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. We intend to cooperate with DOJ and the SEC. We are, at this

time, unable to predict what action, if any, might be taken in the future by DOJ or the SEC as a result of the matters that are the subject of the subpoenas and investigation. The resolution of those investigations may have a material adverse effect on our business, financial condition, results of operations and cash flows.

Our debt obligations could impair our financial condition and limit our operating flexibility.

Our indebtedness under our Restated Facility Agreement and Convertible Notes with Deerfield and our other financial obligations could:

•

impair our ability to obtain financing or additional debt in the future for working capital, capital expenditures, acquisitions or general corporate purposes;

•

impair our ability to access capital and credit markets on terms that are favorable to us;

•

have a material adverse effect on us if we fail to comply with financial and affirmative and restrictive covenants in our Restated Facility Agreement and an event of default occurs as a result of a failure that is not cured or waived;

•

require us to dedicate a portion of our cash flow for interest payments on our indebtedness and other financial obligations, thereby reducing the availability of our cash flow to fund working capital and capital expenditures; and

•

limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate.

Our financial covenants in the Restated Facility Agreement require us to achieve certain levels of net revenue calculated on a rolling monthly basis. Our revenues were, and may continue to be adversely impacted by the COVID-19 pandemic. If we are unable to achieve certain revenue targets, we may breach certain financial covenants set forth in our Restated Facility Agreement. If we breach these covenants, Deerfield will have the right to accelerate repayment of the outstanding amounts. In the event that any of Deerfield accelerates the repayment of our indebtedness, there can be no assurance that we will have sufficient cash on hand to satisfy such obligations and our business operations may be materially harmed.

Furthermore, there is no guarantee that we will be able to pay the principal and interest under the Restated Facility Agreement and the Convertible Notes issued thereunder or that future working capital, borrowings or equity financing will be available to repay or refinance any amounts outstanding under the Restated Facility Agreement and the Convertible Notes issued thereunder. Our obligations under the Convertible Notes are secured by a perfected security interest in all of our tangible and intangible assets (including our intellectual property assets), except for certain customary excluded property and all of our and our subsidiaries capital stock, with certain limited exceptions. In addition, we may enter into debt agreements in the future that may contain similar or more burdensome terms and covenants, including financial covenants.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS

The following exhibits are filed or furnished as part of this report:


Number		Description
4.1		Form of Original Note (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 12, 2022).

4.2		Form of New Note (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October 12, 2022).

4.3		Form of Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on October 12, 2022).

4.4		Form of Exchange Warrant (incorporated by reference to Exhibit 4.4 to the Company’s Current Report on Form 8-K filed on October 12, 2022).

4.5		Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 27, 2022).

4.6		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October 27, 2022).

10.1		Multi-Tenant Office Lease (FSG), dated June 10, 2022, by and between Sientra, Inc. and LBA IV-PPI, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 15, 2022).

10.2		Exchange Agreement, dated October 12, 2022, by and between Sientra, Inc. and Deerfield Partners, L.P. (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on October 12, 2022).

10.3		Amended and Restated Registration Rights Agreement, by and between Sientra, Inc. and Deerfield Partners, L.P. (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on October 12, 2022).

10.4*		Amendment to Amended and Restated Facility Agreement, dated October 20, 2022, by and between Sientra, Inc. and Deerfield Partners, L.P.

10.5		Underwriting Agreement, dated October 21, 2022, by and between Sientra, Inc. and Craig-Hallum Capital Group LLC (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on October 27, 2022).

31.1*		Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.

31.2*		Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.

32.1*		Certification of Principal Executive Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2*		Certification of Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Instance Document - the instance document does not appear in the interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH		Inline XBRL Taxonomy Extension Schema Document.

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document.


101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	SIENTRA, INC.

November 14, 2022	By:	/s/ Ronald Menezes
		Ronald Menezes
		President and Chief Executive Officer

November 14, 2022	By:	/s/ Andrew C. Schmidt
		Andrew C. Schmidt
		Chief Financial Officer and Treasurer