Notes to the Condensed Consolidated Financial Statements
(Unaudited)
|
1.
|
Formation and Business of the Company
|
Sientra, Inc. (“Sientra”, the “Company,” “we,” “our” or “us”), was incorporated in the State of Delaware on August 29, 2003 under the name Juliet Medical, Inc. and subsequently changed its name to Sientra, Inc. in April 2007. The Company acquired substantially all the assets of Silimed, Inc. on April 4, 2007. The purpose of the acquisition was to acquire the rights to the silicone breast implant clinical trials, related product specifications and pre-market approval, or PMA, assets. Following this acquisition, the Company focused on completing the clinical trials to gain FDA approval to offer its silicone gel breast implants in the United States.
In March 2012, the Company announced it had received approval from the FDA for its portfolio of silicone gel breast implants, and in the second quarter of 2012 the Company began commercialization efforts to sell its products in the United States. The Company, based in Santa Barbara, California, is a medical aesthetics company that focuses on serving board-certified plastic surgeons and offers a portfolio of silicone shaped and round breast implants, scar management, tissue expanders, and body contouring products.
In November 2014, the Company completed an initial public offering, or IPO, and its common stock is listed on the Nasdaq Stock Exchange under the symbol “SIEN.”
|
|
b.
|
Regulatory Review of Vesta Manufacturing
|
The Company has engaged Vesta Intermediate Funding, Inc., or Vesta, a Lubrizol Lifesciences company, for the manufacture and supply of the Company’s breast implants. On March 14, 2017, the Company announced it had submitted a site-change pre-market approval, or PMA, supplement to the FDA for the manufacture of the Company’s PMA-approved breast implants at the Vesta manufacturing facility. On January 30, 2018, the Company announced the FDA has granted approval of the site-change supplement for the Company’s contract manufacturer, Vesta, to manufacture its silicone gel breast implants. In support of the move to the Vesta manufacturing facility, the Company also implemented new manufacturing process improvements which, in consultation with the FDA, required three (3) additional PMA submissions. In addition to approving the manufacturing site-change PMA supplement, the FDA approved the Company’s three (3) process enhancement submissions on January 10, 2018, January 19, 2018 and April 17, 2018.
On May 7, 2018, the Company completed an underwritten follow-on public offering of 7,407,408 shares of its common stock at $13.50 per share, as well as 1,111,111 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters. Net proceeds to the Company were approximately $107.6 million after deducting underwriting discounts and commissions of $6.9 million and offering expenses of approximately $0.5 million.
On June 7, 2019, the Company completed an underwritten follow-on public offering of 17,391,305 shares of its common stock at $5.75 per share, as well as 2,608,695 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters. Net proceeds to the Company were approximately $107.7 million after deducting underwriting discounts and commissions of $6.9 million and offering expenses of approximately $0.4 million.
5
|
2.
|
Summary of Significant Accounting Policies
|
The accompanying unaudited condensed consolidated financial statements 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, 2018 filed with the SEC on March 14, 2019, or the Annual Report. The results for the three and nine months ended September 30, 2019 are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period.
Since the Company’s inception, it has incurred significant net operating losses and the Company anticipates that losses will continue in the near term. The Company expects its operating expenses will continue to grow as they expand operations. The Company will need to generate significant net sales to achieve profitability. To date, the Company has funded operations primarily with proceeds from the sales of preferred stock, borrowings under term loans, sales of products since 2012, and the proceeds from the sale of common stock in public offerings.
The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which implies the Company will continue to realize its assets and discharge its liabilities in the normal course of business. As of September 30, 2019, the Company had cash and cash equivalents of $120.9 million. Since inception, the Company has incurred recurring losses from operations and cash outflows from operating activities. The continuation of the Company as a going concern is dependent upon many factors including liquidity and the ability to raise capital. The Company received FDA approval of their PMA supplement on April 17, 2018 and was then able to access a $10.0 million term loan pursuant to an amendment to the credit agreement with MidCap Financial Trust, or MidCap. In addition, in February 2018, the Company entered into an At-The-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, as sales agent pursuant to which the Company may sell, from time to time, through Stifel, shares of our common stock having an aggregate gross offering price of up to $50.0 million. As of September 30, 2019, the Company has not sold any common stock pursuant to the sales agreement. Further, on May 7, 2018 and June 7, 2019, the Company completed public offerings of its common stock, raising approximately $107.6 million and $107.7 million, respectively, in net proceeds after deducting underwriting discounts and commissions and other offering expenses.
On July 1, 2019, the Company entered into certain credit agreements with Midcap Financial Trust pursuant to which the Company repaid its existing indebtedness under its Loan Agreement and the outstanding commitment fee was cancelled. See Note 10 – Long-Term Debt and Revolving Loan for further discussion.
The Company believes that its cash and cash equivalents will be sufficient to fund its operations for at least the next 12 months. To fund ongoing operating and capital needs, the Company may need to raise additional capital in the future through the sale of equity securities and incremental debt financing.
The preparation of the condensed consolidated financial statements, in conformity with GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
6
|
|
d.
|
Recent Accounting Pronouncements
|
Recently Adopted Accounting Standards
In February 2016, the FASB issued Accounting Standards Update, or ASU, 2016-02, Leases (Topic 842). This ASU requires a company to recognize lease assets and liabilities arising from operating leases in the statement of financial position. This ASU does not significantly change the previous lease guidance for how a lessee should recognize the recognition, measurement, and presentation of expenses and cash flows arising from a lease. Additionally, the criteria for classifying a finance lease versus an operating lease are substantially the same as the previous guidance. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption was permitted. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842) Targeted Improvements, amending certain aspects of the new leasing standard. The amendment allowed an additional optional transition method whereby an entity records a cumulative effect adjustment to opening retained earnings in the year of adoption without restating prior periods. The Company adopted Topic 842 on January 1, 2019 electing the package of practical expedients permitted under the transition guidance, which allowed the Company to carry forward the historical lease classification, the assessment on whether a contract is or contains a lease, and the initial direct costs for any leases that exist prior to adoption of the new standard. The Company has not restated prior periods under the optional transition method. The adoption of ASU 2016-02 on January 1, 2019 resulted in the recognition of right-of-use assets of approximately $22.7 million, lease liabilities of approximately $22.9 million and no cumulative-effect adjustment on retained earnings on its Condensed Consolidated Balance Sheets. Refer to Note 9 - Leases for further details.
In February 2018, the FASB issued ASU 2018-02, Income Taxes (Topic 740), which allows for an entity to elect to reclassify the income tax effects on items within accumulated other comprehensive income resulting from U.S. Tax Cuts and Jobs Act to retained earnings. The guidance is effective for fiscal years beginning after December 15, 2018 with early adoption permitted, including interim periods within those years. The Company adopted ASC 2018-02 and elected to not reclassify the income tax effects under ASU 2018-02, as it does not have a material impact on the condensed consolidated financial statements.
Certain reclassifications have been made to prior year amounts to conform to the current year presentation.
Revenue Recognition
The Company generates revenue primarily through the sale and delivery of promised goods or services to customers and recognizes revenue when control is transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for the goods or services. Performance obligations typically include the delivery of promised products, such as breast implants, tissue expanders, BIOCORNEUM, miraDry Systems and bioTips, along with service-type warranties and deliverables under certain marketing programs. Other deliverables are sometimes promised, but are ancillary and insignificant in the context of the contract as a whole. Sales prices are documented in the executed sales contract, purchase order or order acknowledgement prior to the transfer of control to the customer. Customers may enter into a separate extended service agreement to purchase an extended warranty for miraDry products from the Company whereby the payment is due at the inception of the agreement. Typical payment terms are 30 days for Breast Products and direct sales of consumable miraDry products, and tend to be longer for capital sales of miraDry Systems and sales to miraDry distributors, but do not extend beyond one year. 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. Revenue for extended service agreements are recognized ratably over the term of the agreements.
7
For Breast Products, 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. Reserves are established for anticipated sales returns based on the expected amount calculated with historical experience, recent gross sales and any notification of pending returns. The estimated sales return is 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 Company has established an allowance for sales returns of $7.6 million and $6.0 million as of September 30, 2019 and December 31, 2018 respectively, recorded as “sales return liability” on the condensed consolidated balance sheets.
The following table provides a rollforward of the sales return liability (in thousands):
|
|
|
Sales return liability
|
|
|
Balance as of December 31, 2018
|
|
$
|
6,048
|
|
|
Addition to reserve for sales activity
|
|
|
74,621
|
|
|
Actual returns
|
|
|
(73,815
|
)
|
|
Change in estimate of sales returns
|
|
|
709
|
|
|
Balance as of September 30, 2019
|
|
$
|
7,563
|
|
For Breast Products, a portion of the Company’s revenue is generated from the sale of consigned inventory of breast implants 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 implanted, not when the consigned products are delivered to the customer’s location.
For miraDry, in addition to domestic and international direct sales, the Company leverages a distributor network for selling the miraDry System internationally. The Company recognizes revenue when control of the goods or services is transferred to the distributors. Standard terms in both direct sales agreements (domestic and international), and international distributor agreements do not allow for trial periods, right of return, refunds, payment contingent on obtaining financing or other terms that could impact the customer’s payment obligation.
Arrangements with Multiple Performance Obligations
The Company has determined that the delivery of each unit of product in the Company’s revenue contracts with customers is a separate performance obligation. The Company’s revenue contracts may include multiple products or services, each of which is considered a separate performance obligation. For such arrangements, the Company allocates revenue to each performance obligation based on its relative standalone selling price. The Company generally determines standalone selling prices based on observable prices or using an expected cost plus margin approach when an observable price is not available. The Company invoices customers once products are shipped or delivered to customers depending on the negotiated shipping terms.
The Company introduced its Platinum20 Limited Warranty Program, or Platinum20, in May 2018 on all OPUS breast implants implanted in the United States or Puerto Rico on or after May 1, 2018. Platinum20 provides for financial assistance for revision surgeries and no-charge contralateral replacement implants upon the occurrence of certain qualifying events. The Company considers Platinum20 to have an assurance warranty component and a service warranty component. The assurance component is recorded as a warranty liability at the time of sale (as discussed in Note 6). The Company considers the service warranty component as an additional performance obligation and defers revenue at the time of sale based on the relative estimated selling price, by estimating a standalone selling price using the expected cost plus margin approach for the performance obligation. 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, 2019 and December 31, 2018 was $0.9 million and $0.4 million respectively. The short-term obligation related to the service warranty was $0.4 million and $0.2 million as of September 30, 2019 and December 31, 2018, respectively, and is included in “accrued and other current liabilities” on the condensed consolidated balance sheets. The long-term obligation related to the service warranty was $0.5 million and $0.3 million as of September 30, 2019 and December 31, 2018, respectively, and is included in “warranty reserve and other long-term liabilities” on the condensed consolidated balance sheets. The performance obligation is satisfied at the time that Platinum20 benefits are provided and are expected to be satisfied over the following 6 to 24 month period for financial assistance and 20 years for product replacement. Revenue recognized for the service warranty performance obligations for the three and nine months ended September 30, 2019 was immaterial.
8
Practical Expedients and Policy Election
The Company generally expenses sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within sales and marketing expenses.
The Company does not adjust accounts receivable for the effects of any significant financing components as customer payment terms are shorter than one year.
The Company has elected to account for shipping and handling activities performed after a customer obtains control of the products as activities to fulfill the promise to transfer the products to the customer. Shipping and handling activities are largely provided to customers free of charge for the Breast Products segment. The associated costs were $1.4 million and $0.9 million for the nine months ended September 30, 2019 and 2018 respectively. The associated costs were $0.5 million and $0.3 million for the three months ended September 30, 2019 and 2018 respectively. These costs are viewed as part of the Company’s sales and marketing programs and are recorded as a component of sales and marketing expense in the condensed consolidated statement of operations as an accounting policy election. For the miraDry segment, shipping and handling charges are typically billed to customers and recorded as revenue. The shipping and handling costs incurred are recorded as a component of cost of goods sold in the condensed consolidated statement of operations. The associated costs were $0.6 million and $0.2 million for the nine months ended September 30, 2019 and 2018 respectively. The associated costs were $0.3 million and $0.1 million for the three months ended September 30, 2019 and 2018 respectively.
|
4.
|
Fair Value of Financial Instruments
|
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, customer deposits and sales return liability are reasonable estimates of their fair value because of the short maturity of these items. The fair value of the common stock warrant liability and contingent consideration are discussed in Note 5. The fair value of the debt is based on the amount of future cash flows associated with the instrument discounted using the Company’s estimated market rate. As of September 30, 2019, the carrying value of the long-term debt was not materially different from the fair value.
|
5.
|
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.
|
9
The Company’s common stock warrant liabilities are carried at fair value determined according to the fair value hierarchy described above. The Company has utilized an option pricing valuation model to determine the fair value of its outstanding common stock warrant liabilities. The inputs to the model include fair value of the common stock related to the warrant, exercise price of the warrant, expected term, expected volatility, risk-free interest rate and dividend yield. The warrants are valued using the fair value of common stock as of the measurement date. The Company estimates its expected stock volatility based on company-specific historical and implied volatility information of its stock. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company has estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared dividends. As several significant inputs are not observable, the overall fair value measurement of the warrants is classified as Level 3.
The Company assessed the fair value of the contingent consideration for future royalty payments related to the acquisition of BIOCORNEUM and the contingent consideration for the future milestone payments related to the acquisition of miraDry using a Monte-Carlo simulation model. Significant assumptions used in the measurement include future net sales for a defined term and the risk-adjusted discount rate associated with the business. As the 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, 2019 and December 31, 2018 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):
|
|
|
Fair Value Measurements as of
|
|
|
|
|
September 30, 2019 Using:
|
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability for common stock warrants
|
|
$
|
—
|
|
|
|
—
|
|
|
|
3
|
|
|
|
3
|
|
|
Liability for contingent consideration
|
|
|
—
|
|
|
|
—
|
|
|
|
6,437
|
|
|
|
6,437
|
|
|
|
|
$
|
—
|
|
|
|
—
|
|
|
|
6,440
|
|
|
|
6,440
|
|
|
|
|
Fair Value Measurements as of
|
|
|
|
|
December 31, 2018 Using:
|
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability for common stock warrants
|
|
$
|
—
|
|
|
|
—
|
|
|
|
113
|
|
|
|
113
|
|
|
Liability for contingent consideration
|
|
|
—
|
|
|
|
—
|
|
|
|
13,847
|
|
|
|
13,847
|
|
|
|
|
$
|
—
|
|
|
|
—
|
|
|
|
13,960
|
|
|
|
13,960
|
|
The liability for common stock warrants and the current portion of contingent consideration is included in “accrued and other current liabilities” and the long-term liabilities for the contingent consideration are included in “deferred and contingent consideration” in the condensed consolidated balance sheet. The following table provides a rollforward of the aggregate fair values of the Company’s common stock warrants and contingent consideration for which fair value is determined by Level 3 inputs (in thousands):
|
Warrant Liability
|
|
|
|
|
|
Balance, December 31, 2018
|
|
$
|
113
|
|
|
Change in fair value of warrant liability
|
|
|
(110
|
)
|
|
Balance, September 30, 2019
|
|
$
|
3
|
|
|
Contingent Consideration Liability
|
|
|
|
|
|
Balance, December 31, 2018
|
|
$
|
13,847
|
|
|
Settlements of contingent consideration
|
|
|
(8,000
|
)
|
|
Change in fair value of contingent consideration
|
|
|
590
|
|
|
Balance, September 30, 2019
|
|
$
|
6,437
|
|
10
The Company recognizes changes in the fair value of the warrants in “other income (expense), net” in the condensed consolidated statement of operations and changes in contingent consideration are recognized in “general and administrative” expense in the condensed consolidated statement of operations.
The Company offers a product replacement and limited warranty program for the Company’s silicone gel breast implants, and a product warranty for the Company’s miraDry Systems and consumable bioTips. For silicone gel breast implant surgeries occurring prior to May 1, 2018, the Company provides lifetime replacement implants and up to $3,600 in financial assistance for revision surgeries, for covered rupture events that occur within ten years of the surgery date. The Company introduced its Platinum20 Limited Warranty Program in May 2018, covering OPUS silicone gel breast implants implanted in the United States or Puerto Rico on or after May 1, 2018. The Company considers the program to have an assurance warranty component and a service warranty component. The service warranty component is discussed in Note 3 above. The assurance component is related to the lifetime no-charge contralateral replacement implants and up to $5,000 in financial assistance for revision surgeries, for covered rupture events that occur within twenty years of the surgery date. Under the miraDry warranty, the Company provides a standard product warranty for the miraDry System and bioTips, which the Company considers an assurance-type warranty.
The following table provides a rollforward of the accrued warranties (in thousands):
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Balance as of January 1
|
|
$
|
1,395
|
|
|
$
|
1,642
|
|
|
Warranty costs incurred during the period
|
|
|
(492
|
)
|
|
|
(395
|
)
|
|
Changes in accrual related to warranties issued during the period
|
|
|
820
|
|
|
|
639
|
|
|
Changes in accrual related to pre-existing warranties
|
|
|
23
|
|
|
|
(637
|
)
|
|
Balance as of September 30
|
|
$
|
1,746
|
|
|
$
|
1,249
|
|
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 common 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 common shares consist of shares issuable upon the exercise of stock options and warrants (using the treasury stock method). 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,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
Net loss (in thousands)
|
|
$
|
|
(22,433
|
)
|
|
$
|
|
(20,545
|
)
|
|
$
|
(86,571
|
)
|
|
$
|
(57,996
|
)
|
|
Weighted average common shares outstanding, basic
and diluted
|
|
|
|
49,401,094
|
|
|
|
|
28,462,975
|
|
|
|
37,671,215
|
|
|
|
24,312,300
|
|
|
Net loss per share attributable to common stockholders
|
|
$
|
|
(0.45
|
)
|
|
$
|
|
(0.72
|
)
|
|
$
|
(2.30
|
)
|
|
$
|
(2.39
|
)
|
The Company excluded the following potentially dilutive securities, outstanding as of September 30, 2019 and 2018, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2019 and 2018 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.
|
|
|
September 30,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Stock options to purchase common stock
|
|
|
924,097
|
|
|
|
1,926,835
|
|
|
Warrants for the purchase of common stock
|
|
|
47,710
|
|
|
|
47,710
|
|
|
|
|
|
971,807
|
|
|
|
1,974,545
|
|
11
|
8.
|
Balance Sheet Components
|
|
|
a.
|
Allowance for Doubtful Accounts
|
The Company has established an allowance for doubtful accounts of $3.3 million and $2.4 million as of September 30, 2019 and December 31, 2018, respectively, recorded net against accounts receivable in the balance sheet.
Inventories, net consist of the following (in thousands):
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Raw materials
|
|
$
|
3,777
|
|
|
$
|
2,147
|
|
|
Work in progress
|
|
|
1,837
|
|
|
|
2,110
|
|
|
Finished goods
|
|
|
22,869
|
|
|
|
18,335
|
|
|
Finished goods - right of return
|
|
|
1,891
|
|
|
|
1,493
|
|
|
|
|
$
|
30,374
|
|
|
$
|
24,085
|
|
|
|
c.
|
Property and Equipment
|
Property and equipment, net consist of the following (in thousands):
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Leasehold improvements
|
|
$
|
408
|
|
|
$
|
402
|
|
|
Manufacturing equipment and toolings
|
|
|
3,384
|
|
|
|
1,928
|
|
|
Computer equipment
|
|
|
908
|
|
|
|
682
|
|
|
Software
|
|
|
1,441
|
|
|
|
1,039
|
|
|
Office equipment
|
|
|
111
|
|
|
|
156
|
|
|
Furniture and fixtures
|
|
|
1,031
|
|
|
|
826
|
|
|
|
|
|
7,283
|
|
|
|
5,033
|
|
|
Less accumulated depreciation
|
|
|
(3,303
|
)
|
|
|
(2,497
|
)
|
|
|
|
$
|
3,980
|
|
|
$
|
2,536
|
|
Depreciation expense for the three months ended September 30, 2019 and 2018 was $0.3 million and $0.2 million, respectively. Depreciation expense for both the nine months ended September 30, 2019 and 2018 was $0.9 million.
Under the terms of the manufacturing agreement with Vesta, upon the commencement of Contract Year One (as defined in the agreement) which occurred following FDA-approval of all submissions related to the site-change PMA supplement for the Vesta manufacturing facility, Vesta was obligated to purchase the manufacturing equipment and tooling that Sientra had originally purchased for the manufacture of Sientra’s breast implant inventory at Vesta’s manufacturing facility. Vesta repurchased the equipment with a net book value of $2.7 million in the third quarter of 2018 through a reduction in the Company’s accounts payable balance owed to Vesta.
|
|
d.
|
Goodwill and Other Intangible Assets, net
|
The Company has determined that it has two reporting units, Breast Products and miraDry, and evaluates goodwill for impairment at least annually on October 1st and whenever circumstances suggest that goodwill may be impaired. As of September 30, 2019 and December 31, 2018 the miraDry reporting unit had a negative carrying value.
12
The changes in the carrying amount of goodwill during the nine months ended September 30, 2019 were as follows (in thousands):
|
|
|
Breast Products
|
|
|
miraDry
|
|
|
Total
|
|
|
Balances as of December 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
$
|
19,156
|
|
|
$
|
7,629
|
|
|
$
|
26,785
|
|
|
Accumulated impairment losses
|
|
|
(14,278
|
)
|
|
|
—
|
|
|
|
(14,278
|
)
|
|
Goodwill, net
|
|
$
|
4,878
|
|
|
$
|
7,629
|
|
|
$
|
12,507
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances as of September 30, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
$
|
19,156
|
|
|
$
|
7,629
|
|
|
$
|
26,785
|
|
|
Accumulated impairment losses
|
|
|
(14,278
|
)
|
|
|
(7,629
|
)
|
|
|
(21,907
|
)
|
|
Goodwill, net
|
|
$
|
4,878
|
|
|
$
|
—
|
|
|
$
|
4,878
|
|
In the second quarter of 2019, the Company noted a decline in actual and forecasted earnings for the miraDry reporting unit in comparison to forecasted earnings determined in prior periods. Based on this evaluation, the Company determined that the carrying value of the miraDry reporting unit more likely than not exceeded its estimated fair value. As a result, the Company performed a quantitative analysis to compare the fair value of the reporting unit to its carrying amount.
The Company’s fair value analysis of goodwill utilizes the income approach, which requires the use of estimates about a reporting unit’s future revenues and free cash flows, discount rates, terminal value and enterprise value to determine the estimated fair value. The Company’s future revenues and free cash flow assumptions are determined based upon actual results giving effect to management’s expected changes in operating results in future years. The enterprise value, discount rates and terminal value are based upon market participant assumptions using a defined peer group.
After performing the impairment test as of June 30, 2019 the Company determined that the carrying value of its miraDry reporting unit exceeded its estimated fair value using the income approach, as described above, by an amount that indicated a full impairment of the carrying value of goodwill. Consequently, the Company recorded a non-cash goodwill impairment charge of $7.6 million during the second quarter ended June 30, 2019, which is reflected in the accompanying condensed consolidated statement of operations for the nine months ended September 30, 2019.
The components of the Company’s other intangible assets consist of the following (in thousands):
|
|
|
Average
|
|
|
|
|
|
|
|
Amortization
|
|
|
September 30, 2019
|
|
|
|
|
Period
|
|
|
Gross Carrying
|
|
|
Accumulated
|
|
|
Intangible
|
|
|
|
|
(in years)
|
|
|
Amount
|
|
|
Amortization
|
|
|
Assets, net
|
|
|
Intangibles with definite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Customer relationships
|
|
|
11
|
|
|
$
|
9,540
|
|
|
$
|
(3,412
|
)
|
|
$
|
6,128
|
|
|
Trade names - finite life
|
|
|
14
|
|
|
|
2,000
|
|
|
|
(257
|
)
|
|
|
1,743
|
|
|
Developed technology
|
|
|
13
|
|
|
|
1,500
|
|
|
|
(42
|
)
|
|
|
1,458
|
|
|
Non-compete agreement
|
|
|
2
|
|
|
|
80
|
|
|
|
(80
|
)
|
|
|
—
|
|
|
Regulatory approvals
|
|
|
1
|
|
|
|
670
|
|
|
|
(670
|
)
|
|
|
—
|
|
|
Acquired FDA non-gel product approval
|
|
|
11
|
|
|
|
1,713
|
|
|
|
(1,713
|
)
|
|
|
—
|
|
|
Total definite-lived intangible assets
|
|
|
|
|
|
$
|
15,503
|
|
|
$
|
(6,174
|
)
|
|
$
|
9,329
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangibles with indefinite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade names - indefinite life
|
|
—
|
|
|
|
450
|
|
|
|
—
|
|
|
|
450
|
|
|
Total indefinite-lived intangible assets
|
|
|
|
|
|
$
|
450
|
|
|
$
|
—
|
|
|
$
|
450
|
|
13
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
December 31, 2018
|
|
|
|
|
Period
|
|
|
Gross Carrying
|
|
|
Accumulated
|
|
|
Intangible
|
|
|
|
|
(in years)
|
|
|
Amount
|
|
|
Amortization
|
|
|
Assets, net
|
|
|
Intangibles with definite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Customer relationships
|
|
|
11
|
|
|
$
|
11,240
|
|
|
$
|
(3,486
|
)
|
|
$
|
7,754
|
|
|
Trade names - finite life
|
|
|
14
|
|
|
|
5,800
|
|
|
|
(541
|
)
|
|
|
5,259
|
|
|
Developed technology
|
|
|
15
|
|
|
|
3,000
|
|
|
|
(338
|
)
|
|
|
2,662
|
|
|
Distributor relationships
|
|
|
9
|
|
|
|
500
|
|
|
|
(130
|
)
|
|
|
370
|
|
|
Non-compete agreement
|
|
|
2
|
|
|
|
80
|
|
|
|
(80
|
)
|
|
|
—
|
|
|
Regulatory approvals
|
|
|
1
|
|
|
|
670
|
|
|
|
(670
|
)
|
|
|
—
|
|
|
Acquired FDA non-gel product approval
|
|
|
11
|
|
|
|
1,713
|
|
|
|
(1,713
|
)
|
|
|
—
|
|
|
Total definite-lived intangible assets
|
|
|
|
|
|
$
|
23,003
|
|
|
$
|
(6,958
|
)
|
|
$
|
16,045
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangibles with indefinite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade names - indefinite life
|
|
—
|
|
|
|
450
|
|
|
|
—
|
|
|
|
450
|
|
|
Total indefinite-lived intangible assets
|
|
|
|
|
|
$
|
450
|
|
|
$
|
—
|
|
|
$
|
450
|
|
In connection with the circumstances leading to the impairment of goodwill for the miraDry reporting unit, in the second quarter of 2019 the Company performed a test of recoverability of the intangible assets in the miraDry reporting unit by comparing the carrying amount of the intangible assets to the future undiscounted cash flows the assets are expected to generate. As the future undiscounted cash flows attributable to the intangible assets were less than the carrying value, the Company performed a quantitative analysis to compare the fair value of the intangible assets in the reporting unit to their carrying amount.
The Company’s fair value analysis of intangible assets utilizes methods under various income approaches. The Company values its customer relationships using an excess earnings method, which assumes the value of the asset is the discounted cash flow using estimates of future cash flow derived from existing customers. Similarly, distributor relationships are valued using a distributor method, which assumes the value of the asset is the discounted cash flow using estimates of future cash flow derived from existing distributors. Tradenames and developed technology are valued using a relief from royalty method, which assumes the value of the asset is the discounted cash flows of the amount that would be paid by a hypothetical market participant had they not owned the asset and instead licensed the asset from another company.
After performing the impairment test as of June 30, 2019, the Company determined that the carrying values of all of the intangible assets in the miraDry reporting unit exceeded their estimated fair values. Consequently, the Company recorded non-cash impairment charges of $0.4 million for customer relationships, $0.3 million for distributor relationships, $3.3 million for tradenames, and $1.0 million for developed technology within goodwill and other intangible impairment during the second quarter ended June 30, 2019, which is reflected in the accompanying condensed consolidated statement of operations for the nine months ended September 30, 2019.
As of September 30, 2019 the Company assessed qualitative factors in order to determine whether any events or circumstances existed which indicated that it was more likely than not that the fair value of the intangible assets did not exceed their carrying values and concluded no such events or circumstances existed which would require a quantitative impairment analysis to be performed. As such, the Company did not record impairment charges for the three months ended September 30, 2019.
14
Intangibles amortization expense for the three months ended September 30, 2019 and 2018 were $0.5 million and $0.6 million, respectively. Intangibles amortization expense for both the nine months ended September 30, 2019 and 2018 was $1.7 million. The following table summarizes the estimated amortization expense relating to the Company's definite-lived intangible assets as of September 30, 2019 (in thousands):
|
|
|
Amortization
|
|
|
Period
|
|
Expense
|
|
|
Remainder of 2019
|
|
$
|
511
|
|
|
2020
|
|
|
1,554
|
|
|
2021
|
|
|
1,305
|
|
|
2022
|
|
|
1,122
|
|
|
2023
|
|
|
975
|
|
|
Thereafter
|
|
|
3,862
|
|
|
|
|
$
|
9,329
|
|
|
|
e.
|
Accrued and Other Current Liabilities
|
Accrued and other current liabilities consist of the following (in thousands):
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Payroll and related expenses
|
|
$
|
5,729
|
|
|
$
|
6,466
|
|
|
Accrued commissions
|
|
|
3,750
|
|
|
|
5,321
|
|
|
Accrued equipment
|
|
|
1,107
|
|
|
|
18
|
|
|
Deferred and contingent consideration, current portion
|
|
|
6,361
|
|
|
|
7,645
|
|
|
Audit, consulting and legal fees
|
|
|
585
|
|
|
|
703
|
|
|
Accrued sales and marketing expenses
|
|
|
1,314
|
|
|
|
1,374
|
|
|
Operating lease liabilities
|
|
|
5,008
|
|
|
|
—
|
|
|
Finance lease liabilities
|
|
|
41
|
|
|
|
—
|
|
|
Other
|
|
|
4,846
|
|
|
|
6,170
|
|
|
|
|
$
|
28,741
|
|
|
$
|
27,697
|
|
The Company leases certain office space, warehouses, distribution facilities and office equipment. The Company also has embedded leases of manufacturing facilities and equipment associated with the Company’s manufacturing contracts. The Company determines if an arrangement contains a lease at inception by evaluating whether the arrangement conveys the right to use an identified asset and whether the Company obtains substantially all of the economic benefits from and has the ability to direct the use of the asset.
Operating and finance lease right-of-use, or ROU, assets and lease liabilities are recognized based on the present value of the future lease payments over the lease term at the commencement date. The Company determines its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The ROU assets also include any initial direct costs incurred and any lease payments made at or before the lease commencement date, less lease incentives received. Lease terms may include options to extend or terminate when the Company is reasonably certain that the option will be exercised. During the second quarter of 2019, the Company included a five-year renewal option in the lease term for one operating lease as it was concluded that it is reasonably certain that the Company will exercise the option. The Company elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for short-term leases. The Company’s lease agreements generally do not contain material residual value guarantees or material restrictive covenants.
15
The Company’s leases of office space, warehouses and distribution facilities are treated as operating leases and often contain lease and non-lease components. The Company has elected to account for these lease and non-lease components separately. Non-lease components for these assets are primarily comprised of common-area maintenance, utilities, and real estate taxes that are passed on from the lessor in proportion to the space leased by the Company, and are recognized in operating expenses in the period in which the obligation for those payments was incurred. Lease cost for these operating leases is recognized on a straight-line basis over the lease term in operating expenses.
The Company’s embedded leases of manufacturing facilities and equipment are treated as operating leases and often contain lease and non-lease components. The Company has elected to account for these lease and non-lease components as a single lease component. There may be variability in future lease payments as the amount of the non-lease components is based on the costs of manufacturing and is dependent on the amount and types of units produced. The Company reduces the operating lease liability when the inventory is purchased.
The Company’s leases of office equipment are accounted for as finance leases as they meet one or more of the five finance lease classification criteria. Lease cost for these finance leases is comprised of amortization of the ROU asset and interest expense which are recognized in operating expenses and other income (expense), net.
Components of lease expense were as follows:
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
Lease Cost
|
|
Classification
|
|
2019
|
|
|
2019
|
|
|
Operating lease cost
|
|
Operating expenses
|
|
$
|
389
|
|
|
$
|
1,155
|
|
|
Operating lease cost
|
|
Inventory
|
|
|
1,248
|
|
|
|
3,743
|
|
|
Total operating lease cost
|
|
|
|
|
|
$
|
1,637
|
|
|
$
|
4,898
|
|
|
Finance lease cost
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of right-of-use assets
|
|
Operating expenses
|
|
|
10
|
|
|
|
30
|
|
|
Interest on lease liabilities
|
|
Other income (expense), net
|
|
|
1
|
|
|
|
3
|
|
|
Total finance lease cost
|
|
|
|
|
|
$
|
11
|
|
|
$
|
33
|
|
|
Variable lease cost
|
|
Inventory
|
|
|
3,291
|
|
|
|
7,886
|
|
|
Total lease cost
|
|
|
|
|
|
$
|
4,939
|
|
|
$
|
12,817
|
|
Short-term lease expense for both the three and nine months ended September 30, 2019 was immaterial.
Supplemental cash flow information related to operating and finance leases for the nine months ended September 30, 2019 was as follows (in thousands):
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2019
|
|
|
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
|
|
|
Operating cash outflows from operating leases
|
|
$
|
4,605
|
|
|
Operating cash outflows from finance leases
|
|
|
33
|
|
|
Right-of-use assets obtained in exchange for lease obligations:
|
|
|
|
|
|
Operating leases
|
|
$
|
24,779
|
|
|
Finance leases
|
|
|
117
|
|
16
Supplemental balance sheet information, as of September 30, 2019, related to operating and finance leases was as follows (in thousands, except lease term and discount rate):
|
|
|
September 30,
|
|
|
|
|
2019
|
|
|
Reported as:
|
|
|
|
|
|
Other assets
|
|
|
|
|
|
Operating lease right-of-use assets
|
|
$
|
21,263
|
|
|
Finance lease right-of-use assets
|
|
|
88
|
|
|
Total right-of use assets
|
|
$
|
21,351
|
|
|
Accrued and other current liabilities
|
|
|
|
|
|
Operating lease liabilities
|
|
$
|
5,008
|
|
|
Finance lease liabilities
|
|
|
41
|
|
|
Warranty reserve and other long-term liabilities
|
|
|
|
|
|
Operating lease liabilities
|
|
|
16,752
|
|
|
Finance lease liabilities
|
|
|
45
|
|
|
Total lease liabilities
|
|
$
|
21,846
|
|
|
Weighted average remaining lease term (years)
|
|
|
|
|
|
Operating leases
|
|
|
4
|
|
|
Finance leases
|
|
|
2
|
|
|
Weighted average discount rate
|
|
|
|
|
|
Operating leases
|
|
|
8.08
|
%
|
|
Finance leases
|
|
|
4.12
|
%
|
As of September 30, 2019, maturities of the Company’s operating and finance lease liabilities are as follows (in thousands):
|
Period
|
|
Operating leases
|
|
|
Finance leases
|
|
|
Total
|
|
|
Remainder of 2019
|
|
$
|
1,652
|
|
|
$
|
11
|
|
|
$
|
1,663
|
|
|
2020
|
|
|
6,640
|
|
|
|
43
|
|
|
|
6,683
|
|
|
2021
|
|
|
6,672
|
|
|
|
36
|
|
|
|
6,708
|
|
|
2022
|
|
|
6,405
|
|
|
|
—
|
|
|
|
6,405
|
|
|
2023
|
|
|
3,083
|
|
|
|
—
|
|
|
|
3,083
|
|
|
2024 and thereafter
|
|
|
964
|
|
|
|
—
|
|
|
|
964
|
|
|
Total lease payments
|
|
$
|
25,416
|
|
|
$
|
90
|
|
|
$
|
25,506
|
|
|
Less imputed interest
|
|
|
3,656
|
|
|
|
4
|
|
|
|
3,660
|
|
|
Total operating lease liabilities
|
|
$
|
21,760
|
|
|
$
|
86
|
|
|
$
|
21,846
|
|
As previously reported in our Annual Report on Form 10-K for the year ended December 31, 2018 and under legacy lease accounting (ASC 840), future minimum lease payments under non-cancellable leases as of December 31, 2018 was as follows (in thousands):
|
Year Ended December 31:
|
|
|
|
|
|
2019
|
|
$
|
1,325
|
|
|
2020
|
|
|
1,134
|
|
|
2021
|
|
|
1,060
|
|
|
2022
|
|
|
947
|
|
|
2023 and thereafter
|
|
|
1,557
|
|
|
|
|
$
|
6,023
|
|
17
The table above does not include the minimum purchase obligations of approximately $21.6 million over the five years following December 31, 2018 under the Company’s contracts with its manufacturers which upon adoption of ASU 2016-02 on January 1, 2019 were accounted for as operating lease ROU assets and lease liabilities.
|
10.
|
Long-Term Debt and Revolving Loan
|
On July 25, 2017, the Company entered into a Credit and Security Agreement, or the Existing Term Loan Credit Agreement, and a Credit and Security Agreement, or the Existing Revolving Credit Agreement with MidCap Financial Trust, which replaced the Company’s prior Silicon Valley Bank Loan Agreement, or the SVB Loan Agreement. On July 1, 2019 the Company entered into a Restated Term Loan Credit Agreement with MidCap Financial Trust as the agent and lender, and additional lenders thereto from time to time, or the Restated Term Loan Agreement, which restated the Existing Term Loan Agreement. Also on July 1, 2019, the Company entered into an Amended and Restated Credit and Security Agreement (Revolving Loan), by and among the Company, the lenders party thereto from time to time, and MidCap Financial Trust, or the Restated Revolving Credit Agreement and, together with the Restated Term Loan Agreement, the Credit Agreements, which restated the Existing Revolving Credit Agreement.
The Restated Term Loan Agreement provided for (i) a $35 million term loan facility drawn at signing, (ii) a $5 million term loan facility drawn at signing, (iii) at any time after September 30, 2020 to December 31, 2020, a $10.0 million term loan facility (subject to the satisfaction of certain conditions, including evidence that the Company’s Net Revenue for the past 12 months was greater than or equal to $100.0 million), and (iv) until December 31, 2020 and upon the consent of Agent and the lenders following a request from the Company, an additional $15.0 million term loan facility, or altogether, the Restated Term Loan. The Restated Term Loan matures on July 1, 2024 and carries an interest rate of LIBOR plus 7.50%. The Company will make monthly payments of accrued interest under the Restated Term Loan from the funding date of the Restated Term Loan, until July 31, 2021, to be followed by monthly installments of principal and interest through the Maturity Date of July 1, 2024. The Company may prepay all of the Restated Term Loan prior to its maturity date provided the Company pays MidCap a prepayment fee. Net proceeds from the Restated Term Loan were used to repay the $35 million outstanding balance related to the Term Loans. As of September 30, 2019, there was $40.0 million outstanding related to the Restated Term Loans. As of September 30, 2019, the long-term portion of the unamortized debt issuance costs on the Restated Term Loans was approximately $1.9 million and are included as a reduction to debt on the condensed consolidated balance sheet. As of September 30, 2019, there was no current portion of unamortized debt issuance costs.
The Restated Revolving Credit Agreement provides for, among other things, a revolving loan of up to $10.0 million (the “Restated Revolving Loan”). The amount of loans available to be drawn under the Revolving Credit Agreement is based on a borrowing base equal to 85% of the net collectible value of eligible accounts receivable plus 40% of eligible finished goods inventory, or the Borrowing Base, provided that availability from eligible finished goods inventory does not exceed 20% of the Borrowing Base. The Restated Revolving Loan carries an interest rate of LIBOR plus 4.50%. The Borrowers may make (subject to the applicable borrowing base at the time) and repay borrowings from time to time under the Restated Revolving Credit Agreement until the maturity of the facility on July 1, 2024. Immediately prior to the effectiveness of the Restated Revolving Credit Agreement, the Company converted the $4.3 million outstanding borrowings under the Revolving Loan into the Restated Revolving Loan. As of September 30, 2019, there were $7.4 million borrowings outstanding under the Revolving Loan. As of September 30, 2019, the unamortized debt issuance costs related to the Revolving Loan was approximately $0.1 million and was included in other long-term assets on the condensed consolidated balance sheet.
The amortization of debt issuance costs for the three months ended September 30, 2019 and 2018 was $0.1 million and $47,000, respectively. The amortization of debt issuance costs for the nine months ended September 30, 2019 and 2018 was $0.2 million and $0.1 million, respectively and was included in interest expense in the condensed consolidated statements of operations.
The Credit 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.
18
Future Principal Payments of Debt
The future schedule of principal payments for the outstanding Term Loans as of September 30, 2019 was as follows (in thousands):
|
Fiscal Year
|
|
|
|
|
|
Remainder of 2019
|
|
$
|
—
|
|
|
2020
|
|
|
—
|
|
|
2021
|
|
|
5,556
|
|
|
2022
|
|
|
13,333
|
|
|
2023
|
|
|
13,333
|
|
|
Thereafter
|
|
|
7,778
|
|
|
Total
|
|
$
|
40,000
|
|
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, 2019 and December 31, 2018, the Company had no preferred stock issued or outstanding.
On January 17, 2013, the Company entered into a Loan and Security Agreement, or the Original Term Loan Agreement, with Oxford Finance, LLC, or Oxford. On June 30, 2014, the Company entered into an Amended and Restated Loan and Security Agreement, or the Amended Term Loan Agreement, with Oxford. In connection with the Original Term Loan Agreement and the Amended Term Loan Agreement, the Company issued to Oxford (i) seven-year warrants in January 2013 to purchase shares of the Company’s common stock with a value equal to 3.0% of the tranche A, B and C term loans amounts and (ii) seven-year warrants in June 2014 to purchase shares of the Company’s common stock with a value equal to 2.5% of the tranche D term loan amount. The warrants have an exercise price per share of $14.671. As of September 30, 2019, there were warrants to purchase an aggregate of 47,710 shares of common stock outstanding.
In April 2007, the Company adopted the 2007 Equity Incentive Plan, or the 2007 Plan. The 2007 Plan provides for the granting of stock options to employees, directors and consultants of the Company. Options granted under the 2007 Plan may either be incentive stock options or nonstatutory stock options. Incentive stock options, or ISOs, may be granted only to Company employees. Nonstatutory stock options, or NSOs, may be granted to all eligible recipients. A total of 1,690,448 shares of the Company’s common stock were initially reserved for issuance under the 2007 Plan.
The Company’s board of directors adopted the 2014 Equity Incentive Plan, or 2014 Plan, in July 2014, and the stockholders approved the 2014 Plan in October 2014. The 2014 Plan became effective upon completion of the IPO on November 3, 2014, at which time the Company ceased granting awards under the 2007 Plan. Under the 2014 Plan, the Company may issue ISOs, NSOs, stock appreciation rights, restricted stock awards, restricted stock unit awards and other forms of stock awards, or collectively, stock awards, all of which may be granted to employees, including officers, non-employee directors and consultants of the Company and their affiliates. ISOs may be granted only to employees. A total of 1,027,500 shares of common stock were initially reserved for issuance under the 2014 Plan, subject to certain annual increases. As of September 30, 2019, a total of 541,244 shares of the Company’s common stock were available for issuance under the 2014 Plan.
19
Pursuant to a board-approved Inducement Plan, the Company may issue NSOs and restricted stock unit awards, or collectively, stock awards, all of which may only be granted to new employees of the Company in accordance with NASDAQ Stock Market Rule 5635(c)(4) as an inducement material to such individuals entering into employment with the Company. As of September 30, 2019, inducement grants for 1,201,728 shares of common stock have been awarded, and 266,652 shares of common stock were available for future issuance under the Inducement Plan.
Options under the 2007 Plan and the 2014 Plan may be granted for periods of up to ten years as determined by the Company’s board of directors, provided, however, that (i) the exercise price of an ISO shall not be less than 100% of the estimated fair value of the shares on the date of grant, and (ii) the exercise price of an ISO granted to a more than 10% shareholder shall not be less than 110% of the estimated fair value of the shares on the date of grant. An NSO has no such exercise price limitations. NSOs under the Inducement Plan may be granted for periods of up to ten years as determined by the board of directors, provided, the exercise price will 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 (years)
|
|
|
Balances at December 31, 2018
|
|
|
1,953,334
|
|
|
$
|
7.42
|
|
|
|
6.30
|
|
|
Exercised
|
|
|
(48,724
|
)
|
|
|
2.37
|
|
|
|
|
|
|
Forfeited
|
|
|
(10,500
|
)
|
|
|
16.24
|
|
|
|
|
|
|
Balances at September 30, 2019
|
|
|
1,894,110
|
|
|
$
|
7.50
|
|
|
|
5.72
|
|
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 was $0.1 million and $0.5 million for the three months ended September 30, 2019 and 2018, respectively. Stock-based compensation expense related to stock options was $0.4 million and $1.3 million for the nine months ended September 30, 2019 and 2018, respectively. As of September 30, 2019, there was $0.1 million of unrecognized compensation costs related to stock options. The expense is recorded within the operating expense components in the condensed consolidated statement of operations based on the recipients receiving the awards. These costs are expected to be recognized over a weighted average period of less than 1 year.
|
|
d.
|
Restricted Stock Units
|
The Company has issued restricted stock unit awards, or RSUs, under the 2014 Plan and the Inducement Plan. The RSUs issued to employees generally vest on a straight-line basis annually over a 3-year requisite service period. RSUs issued to non-employees generally vest either monthly or annually over the service term.
Activity related to RSUs is set forth below:
|
|
|
|
|
|
|
Weighted
average
|
|
|
|
|
Number
|
|
|
grant date
|
|
|
|
|
of shares
|
|
|
fair value
|
|
|
Balances at December 31, 2018
|
|
|
2,141,350
|
|
|
$
|
13.27
|
|
|
Granted
|
|
|
1,314,547
|
|
|
|
8.01
|
|
|
Vested
|
|
|
(852,375
|
)
|
|
|
12.13
|
|
|
Forfeited
|
|
|
(280,399
|
)
|
|
|
14.14
|
|
|
Balances at September 30, 2019
|
|
|
2,323,123
|
|
|
$
|
10.60
|
|
20
Stock-based compensation expense for RSUs for the three months ended September 30, 2019 and 2018 was $2.8 million and $3.7 million, respectively. Stock-based compensation expense for RSUs for the nine months ended September 30, 2019 and 2018 was $8.9 million and $8.3 million, respectively. As of September 30, 2019, there was $16.5 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 2 years.
|
|
e.
|
Employee Stock Purchase Plan
|
The Company’s board of directors adopted the 2014 Employee Stock Purchase Plan, or ESPP, in July 2014, and the stockholders approved the ESPP in October 2014. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides for offering periods not to exceed 27 months, and each offering period will include purchase periods, which will be the approximately six-month period commencing with one exercise date and ending with the next exercise date. Employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the purchase date. A total of 255,500 shares of common stock were initially reserved for issuance under the ESPP, subject to certain annual increases.
During the nine months ended September 30, 2019, employees purchased 175,624 shares of common stock at a weighted average price of $6.93 per share. As of September 30, 2019, the number of shares of common stock available for future issuance was 654,619.
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 $0.2 million for both the three months ended September 30, 2019 and 2018. Stock-based compensation expense related to the ESPP was $0.5 million and $0.4 million for the nine months ended September 30, 2019 and 2018, respectively.
|
|
f.
|
Significant Modifications
|
During the nine months ended September 30, 2019 the Company entered into two consulting agreements with former employees that resulted in modifications of their existing equity awards. During the nine months ended September 30, 2019 the Company recognized $0.6 million in incremental compensation cost resulting from these modifications.
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 the three and nine months ended September 30, 2019 and 2018.
Reportable Segments
The Company has two reportable segments: Breast Products and miraDry. The Breast Products segment focuses on sales of silicone gel breast implants, tissue expanders and scar management products under the brands Opus, AlloX2, Dermaspan, Softspan and BIOCORNEUM. The miraDry segment focuses on sales of the miraDry System, consisting of a console and a handheld device which uses consumable single-use bioTips. These segments align with the Company’s principal target markets.
The Company’s Chief Operating Decision Maker, or CODM, assesses the performance of each segment and allocates resources to those segments based on net sales and operating income (loss). Operating income (loss) by segment includes items that are directly attributable to each segment, including sales and marketing functions, as well as finance, information technology, human resources, legal and related corporate infrastructure costs, along with certain benefit-related expenses. There are no unallocated expenses for the two segments.
21
The following tables present the net sales, net operating loss and net assets by reportable segment for the periods presented (in thousands):
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
Net sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast Products
|
|
$
|
12,626
|
|
|
$
|
8,613
|
|
|
$
|
33,570
|
|
|
$
|
26,566
|
|
|
miraDry
|
|
|
9,786
|
|
|
|
8,262
|
|
|
|
26,919
|
|
|
|
22,538
|
|
|
Total net sales
|
|
$
|
22,412
|
|
|
$
|
16,875
|
|
|
$
|
60,489
|
|
|
$
|
49,104
|
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
Loss from operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast Products
|
|
$
|
(12,319
|
)
|
|
$
|
(13,873
|
)
|
|
$
|
(38,555
|
)
|
|
$
|
(39,111
|
)
|
|
miraDry
|
|
|
(9,141
|
)
|
|
|
(5,689
|
)
|
|
|
(45,722
|
)
|
|
|
(16,278
|
)
|
|
Total loss from operations
|
|
$
|
(21,460
|
)
|
|
$
|
(19,562
|
)
|
|
$
|
(84,277
|
)
|
|
$
|
(55,389
|
)
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
|
|
|
|
2019
|
|
|
2018
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast Products
|
|
|
|
|
|
$
|
186,298
|
|
|
$
|
130,149
|
|
|
miraDry
|
|
|
|
|
|
|
33,584
|
|
|
|
38,210
|
|
|
Total assets
|
|
|
|
|
|
$
|
219,882
|
|
|
$
|
168,359
|
|
|
14.
|
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.
miraDry Class Action Litigation
On August 3, 2017, a lawsuit styled as a verified class action on the part of the former stockholders of miraDry was filed in the Court of Chancery for the State of Delaware against the former board of directors of miraDry, or the Defendants, alleging breach of their fiduciary duties in connection with the Company’s acquisition of miraDry. On August 30, 2017, the Defendants moved to dismiss the verified class action complaint for failure to state a claim upon which relief can be granted. On November 11, 2017 the parties notified the Court that they had reached an agreement to settle the matter pending completion of confirmatory discovery regarding the fairness of the settlement and obtaining approval from the court. Following a hearing, the Delaware Chancery Court approved the proposed settlement terms on January 15, 2019, with a modification to the amount of attorneys’ fees awarded to the plaintiffs’ attorneys. Under the terms of the settlement, in exchange for a full and final settlement and release of all claims, the Defendants (and/or their indemnitors and/or insurers) paid a settlement consideration of $0.4 million. The miraDry Merger Agreement contained a holdback amount expected to be used for the settlement and associated costs of the miraDry Class Action litigation. The holdback amount has been used to offset $0.6 million of legal fees and $0.4 million was included in “legal settlement payable” on the consolidated balance sheet as of December 31, 2018. The legal settlement of $0.4 million was paid during the first quarter of 2019.
22
Vesta Asset Acquisition
On November 7, 2019 (the “Closing Date”), the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Vesta Intermediate Fundings, Inc. (“Vesta”), pursuant to which the Company purchased certain assets and assumed certain liabilities and obtained a non-exclusive, royalty-free, perpetual, irrevocable, assignable, sublicensable, and worldwide license to certain intellectual property owned by Vesta (the “Vesta Acquisition”). In consideration of the Vesta Acquisition, the Company paid $14.0 million in cash on the Closing Date and will pay an additional $3.2 million and $3.0 million in cash (the “Post-Closing Amounts”) on November 7, 2021 and November 7, 2023, respectively. In addition, in the event the closing price of the Company’s common stock equals or exceeds a certain agreed upon price target (the “First Milestone Price Target”) on any date through November 7, 2023, the Company will issue Vesta 303,721 shares of common stock (the “First Milestone Shares”) within five business days of such date and in the event the closing price of the Company’s common stock equals or exceeds a certain agreed upon price target (the “Second Milestone Price Target”) on any date through November 7, 2023, the Company will issue Vesta 303,721 shares of common stock (the “Second Milestone Shares”) within five business days of such date. The Company will use its commercially reasonable efforts to file and maintain a resale registrations statement registering the resale of the First Milestone Shares and the Second Milestone Shares. The Purchase Agreement contains customary representations and warranties and indemnification provisions. The Purchase Agreement also includes a two-year, mutual non-solicitation agreement.
In connection with, and as a condition to the closing of, the Purchase Agreement, on November 7, 2019, the Company entered into a Lease with Vesta (the “Lease”) whereby the Company will lease approximately 24,000 square feet in the building where the manufacturing operations acquired in the Vesta Acquisition are located (the “Facility”). The Lease has an initial term of four years (the “Initial Term”). The Company will pay annual rent of $200,000 for each of the first two years and $320,000 for each of the third and fourth years of the Lease payable in equal monthly installments. The Lease includes an option for the Company to extend the term of the Lease one time for an additional four years (the “Extended Term”). The annual rent payable during the Extended Term shall be the annual rent payable during the Initial Term increased by the percentage increase in the Consumer Price Index, as specified in the Lease. The Lease contains customary events of default and, additionally, any failure by the Company to pay the Post-Closing Amounts when due or issue the First Milestone Shares or Second Milestone Shares when required shall be considered an event of default. The Lease also provides that, in the event of a sale of the Facility, the Company will have a right of first offer to purchase the Facility from Vesta.
Sientra is currently evaluating the purchase price allocation following the consummation of the Vesta Acquisition. It is not practicable to disclose the preliminary purchase price allocation, given the short period of time between the acquisition date and the issuance of these consolidated financial statements.
Tissue Expander Manufacturing Agreement
On November 7, 2019, the Company entered into an Amended and Restated Manufacturing and Supply Agreement (the “Manufacturing Agreement”) with Vesta Intermediate Funding, Inc. (“Vesta”), providing for the manufacture and supply of the Company’s tissue expanders and accessories (the “Expander Products”). The Manufacturing Agreement has a six-year term, which may be extended by written agreement of the parties, and may only be terminated for cause by the non-defaulting party following written notice of default with a reasonable period to cure. The Manufacturing Agreement provides that the Company will purchase fixed percentages of its requirements for Expander Products intended for global distribution from Vesta, with such percentages decreasing over time. In the event that Vesta fails to timely deliver a minimum threshold of the Expander Product orders for a specified period, the purchase requirements shall be adjusted downwards as provided in the Manufacturing Agreement. The Manufacturing Agreement contains customary representations and warranties.
Supply Agreement
On November 7, 2019, the Company entered into a Master Supply Agreement (the “Supply Agreement”) with NuSil Technology LLC (“NuSil”) which provides that NuSil will serve as the exclusive supplier of the Company’s silicone materials for short and long-term implantable products (the “Silicone Products”). The Supply Agreement provides for Set Pricing and Discount Pricing that the Company is able to obtain upon reaching certain minimum purchase requirements in a calendar year. The Supply Agreement has an initial term through December 31, 2026 (the “Initial
23
Term”) which automatically renews for subsequent one year terms (each, a “Renewal Term”), unless a party provides written notice of intent to terminate the Supply Agreement no later than six (6) months prior to expiration of the Initial Term or the then current Renewal Term. The Supply Agreement may be terminated in the event of breach following a 45 day period to cure or in the event of insolvency of a party.
Organizational Efficiency Initiative
On November 6, 2019, the Board of Directors of the Company approved an organizational efficiency initiative (the “Plan”) designed to reduce spending and simplify operations, effective immediately. Under the Plan, the Company will implement numerous initiatives to reduce spending, including closing the Santa Clara offices of miraDry, Inc. (“miraDry”), outsourcing miraDry product assembly to a third party, and consolidating a number of business support services via a shared services organization at the Company’s Santa Barbara headquarters. Under the Plan, the Company intends to reduce its workforce by terminating approximately 70 employees, which the Company expects to be completed over the next 10 months. As a result, the Company expects to incur charges between $2.7 million and $3.0 million in connection with one-time employee termination costs, retention costs and other benefits. These charges are expected to be incurred over the next 10 months. In addition, the Company expects to incur estimated charges between $1.0 million and $1.5 million related to contract termination, outsourcing miraDry product assembly and duplicate operating costs over the next 10 months. In total, the Plan is estimated to cost between $3.7 million and $4.5 million over the next 10 months, excluding non-cash charges, with related cash payments expected to be substantially paid out by September 30, 2020.
The estimates of costs that the Company expects to incur and the timing thereof are subject to a number of assumptions and actual results may differ.
Huiner Settlement and Consulting Agreement
As previously disclosed, on September 30, 2019 (the “Separation Date”), Charles Huiner, the Company’s Chief Operating Officer and Senior Vice President of Corporate Development and Strategy, stepped down from his role to pursue other opportunities. On November 1, 2019, the Company entered into a Confidential Settlement, Release and Consulting Agreement with Mr. Huiner (the “Huiner Agreement”). Pursuant to the Huiner Agreement, in exchange for a general release of all claims, the Company will (1) pay Mr. Huiner, in accordance with the Company’s regular payroll cycle, an amount equal to twelve months of his base salary in effect on the Separation Date, or $393,225, (2) make a lump sum payment equal to Mr. Huiner’s bonus for 2019 prorated through the Separation Date and based upon the achievement of objectives and the determination of the Board of Directors of the final 2019 corporate bonus payout, payable by check in a lump sum no later than April 1, 2020 and (3) reimburse Mr. Huiner for COBRA premiums until the earlier of (1) thirteen months following the Separation Date (2) the date Mr. Huiner is eligible for group health insurance coverage through a new employer or (3) the date Mr. Huiner ceases to be eligible for COBRA continuation coverage for any reason. In addition, the Huiner Agreement provides that Mr. Huiner will continue to provide consulting services (the “Services”) for eight months following the Separation Date. As consideration for the Services, the Company will pay Mr. Huiner a one-time lump sum consulting fee of $32,768.76, continue the vesting of all unvested restricted stock units and performance stock units granted in April 2019 and accelerated the vesting of 33,333 restricted stock units granted in January 2018. In addition, the Huiner Agreement extends the exercise period for any vested stock options until thirteen months from the Separation Date.
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. The Company intends to vigorously defend itself in this lawsuit.
24