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.
|
Acquisition of miraDry
|
On June 11, 2017, Sientra entered into an Agreement and Plan of Merger, or the Merger Agreement, with miraDry (formerly Miramar Labs), pursuant to which Sientra commenced a tender offer to purchase all of the outstanding shares of miraDry’s common stock for (i) $0.3149 per share, plus (ii) the contractual right to receive one or more contingent payments upon the achievement of certain future sales milestones. The total merger consideration was $18.7 million in upfront cash and the contractual rights represent potential contingent payments of up to $14 million. The transaction, which closed on July 25, 2017, added the miraDry System to Sientra’s aesthetics portfolio.
|
c.
|
Acquisition of certain assets from Vesta Intermediate Funding, Inc.
|
On November 7, 2019, the Company entered into an Asset Purchase Agreement, or the Purchase Agreement, with Vesta Intermediate Funding, Inc., or Vesta, pursuant to which the Company purchased certain assets and obtained a non-exclusive, royalty-free, perpetual, irrevocable, assignable, sublicensable, and worldwide license to certain intellectual property owned by Vesta, or the Vesta Acquisition. The total consideration was $ 19.1 million in cash, $3.2 million and $3.0 million in cash payable on November 7, 2021 and November 7, 2023, respectively, and two contingent share issuances of up to 303,721 shares each, of the Company’s common stock upon the achievement of certain price targets. The transaction, which closed on November 7, 2019, allows the Company to achieve a greater degree of vertical integration, obtaining direct control of breast implant manufacturing and product development activities and generating production-related cost synergies.
|
d.
|
Regulatory Review of Vesta Manufacturing
|
Prior to the asset acquisition on November 7, 2019, the Company engaged Vesta 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 manufacture of its silicone gel breast implants at the Vesta manufacturing facility. 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.
5
|
e.
|
Follow-On Offerings and At-The-Market Share Issuance
|
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.
Further, during the first quarter of 2020, the Company sold 37,000 shares of its common stock under the At-The-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated which was entered into in February 2018. Net proceeds to the Company after commissions were approximately $0.3 million.
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, 2019 filed with the SEC on March 16, 2020, or the Annual Report. The results for the three months ended March 31, 2020 are not necessarily indicative of results to be expected for the year ending December 31, 2020, 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. Although the Company expects its operating expenses will begin to decrease with the implementation of the organizational efficiency initiative announced on November 7, 2019, and other measures introduced as announced in the Company’s filing on Form 8-K on April 7, 2020, 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 and convertible note, 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 March 31, 2020, the Company had cash and cash equivalents of $112.1 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 its 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
6
million. As of March 31, 2020, the Company has sold 37,000 shares of its common stock pursuant to the sales agreement, resulting in net proceeds after commissions of approximately $0.3 million. 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. On May 11, 2020, the Company amended certain credit agreements with Midcap Financial Trust pursuant to which the Company repaid certain amounts of its existing indebtedness. See Note 11 – Debt and Note 16 – Subsequent Events for further discussion.
On March 11, 2020, the Company entered into a facility agreement with Deerfield Partners, L.P., issuing $60.0 million in principal amount of 4.0% unsecured and subordinated convertible notes upon the terms and conditions set forth in the facility agreement. See Note 11 – Debt 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.
|
d.
|
Recent Accounting Pronouncements
|
Recently Adopted Accounting Standards
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. The amendment modifies, removes, and adds certain disclosure requirements on fair value measurements. The ASU is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption was permitted. The Company adopted the applicable amendments within ASU 2018-13 prospectively in the first quarter of 2020 and there was no material impact on its condensed consolidated financial statements from the adoption.
In August 2018, the FASB issued ASU 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40) - Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract. The amendment aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license). The accounting for the service element of a hosting arrangement that is a service contract is not affected by the amendment. The ASU is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019. Early adoption was permitted. The Company adopted ASU 2018-15 prospectively in the first quarter of 2020 and there was no material impact on its condensed consolidated financial statements from the adoption.
7
Recently Issued 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 is currently evaluating the impact the election of the optional expedient will have on the consolidated financial statements.
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendment removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation, and calculating income taxes in interim periods. The amendment also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. The ASU is effective for annual and interim periods in fiscal years beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating the impact that adoption of the standard will have on the consolidated financial statements.
|
e.
|
Risks and Uncertainties
|
On March 11, 2020, the World Health Organization declared the outbreak of a novel strain of coronavirus, also known as COVID-19, a global pandemic. Due to the pandemic, there has been uncertainty and disruption in the global economy and significant volatility of financial markets. The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, and employee-related amounts, will depend on future developments that are highly uncertain. 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.
As an aesthetics company, the Company's products are susceptible to local and national government restrictions, such as social distancing, “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. The inability to perform such non-emergency procedures has harmed the Company’s revenues for the period ending March 31, 2020 and will likely result in future harm while these or new restrictions remain in place. In addition, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that this can lead to a local and/or global economic recession, which may result in further harm to the aesthetics market. Such economic disruption could adversely affect the Company’s business.
The estimates used for, but not limited to, determining the collectability of accounts receivable, fair value of long-lived assets, and goodwill could be impacted by the pandemic. While the full impact 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.
Certain reclassifications have been made to prior year amounts to conform to the current year presentation.
8
On November 7, 2019, the Company announced an organizational efficiency initiative, or the Plan, designed to reduce spending and simplify operations. Under the Plan, the Company will implement numerous initiatives to reduce spending, including closing the Santa Clara offices of miraDry, Inc. 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. The Company expects to incur total charges of approximately $4.1 million in connection with one-time employee termination costs, retention costs and other benefits. In addition, the Company expects to incur estimated charges of approximately $0.7 million related to contract termination costs, duplicate operating costs, and other associated costs. In total, the Plan is estimated to cost approximately $4.8 million, excluding non-cash charges, with related cash payments expected to be substantially paid out with cash on hand by the end of 2020.
The following table details the amount of the liabilities related to the Plan included in "Accrued and other current liabilities" in the condensed consolidated balance sheet as of March 31, 2020 (amounts in thousands):
|
|
Severance costs
|
|
|
Other associated costs
|
|
Balance at December 31, 2019
|
|
$
|
894
|
|
|
$
|
—
|
|
Costs charged to expense
|
|
|
1,642
|
|
|
|
97
|
|
Costs paid or otherwise settled
|
|
|
(632
|
)
|
|
|
(97
|
)
|
Balance at March 31, 2020
|
|
$
|
1,904
|
|
|
$
|
—
|
|
During the three months ended March 31, 2020, the Company recorded $1.7 million of severance and other associated costs related to the Plan. The following table details the charges by reportable segment, recorded in "Restructuring" under operating expenses in the condensed consolidated statements of operations for the three months ended March 31, 2020 by segment (amounts in thousands):
|
|
Year Ended
|
|
|
Three Months
|
|
|
Cumulative Restructuring
|
|
|
|
December 31, 2019
|
|
|
Ended March 31, 2020
|
|
|
Charges
|
|
Breast Products
|
|
$
|
499
|
|
|
$
|
828
|
|
|
$
|
1,327
|
|
miraDry
|
|
|
584
|
|
|
|
911
|
|
|
|
1,495
|
|
Total
|
|
$
|
1,083
|
|
|
$
|
1,739
|
|
|
$
|
2,822
|
|
The Company has incurred cumulative restructuring charges of $2.8 million since the commencement of the restructuring plan through March 31, 2020. It is anticipated that the Company will additionally incur approximately $2.0 million of total restructuring costs during the remainder of 2020, of which $0.1 million would be attributable to the Breast Products segment and $1.9 million would be attributable to the miraDry segment. As the development of the Plan is completed, the Company will update its estimated costs by reportable segment as needed.
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
9
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.
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 $8.7 million and $8.1 million as of March 31, 2020 and December 31, 2019 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, 2019
|
|
$
|
8,116
|
|
Addition to reserve for sales activity
|
|
|
28,538
|
|
Actual returns
|
|
|
(28,074
|
)
|
Change in estimate of sales returns
|
|
|
127
|
|
Balance as of March 31, 2020
|
|
$
|
8,707
|
|
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 7). 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
10
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 March 31, 2020 and December 31, 2019 was $1.3 million and $1.2 million, respectively. The short-term obligation related to the service warranty as of both March 31, 2020 and December 31, 2019 was $0.5 million and is included in “accrued and other current liabilities” on the condensed consolidated balance sheets. The long-term obligation related to the service warranty as of March 31, 2020 and December 31, 2019 was $0.8 million and $0.7 million, 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 3 to 24 month period for financial assistance and 20 years for product replacement. Revenue recognized for the service warranty performance obligations for the three months ended March 31, 2020 was immaterial.
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 $0.7 million and $0.4 million for the three months ended March 31, 2020 and 2019, 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 $0.1 million for both the three months ended March 31, 2020 and 2019.
5.
|
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, contingent consideration, and the convertible feature related to the convertible note are discussed in Note 6. The fair value of debt is based on the amount of future cash flows associated with the instrument discounted using the Company’s estimated market rate. As of March 31, 2020, the carrying value of the long-term debt and convertible note was not materially different from the fair value.
6.
|
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.
|
11
|
•
|
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.
|
Common Stock Warrants
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 of March 31, 2020, the fair value of the warrants was immaterial as a result of the decline in the Company’s stock price.
Contingent Consideration
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. The contingent consideration related to the acquisition of BIOCORNEUM consist 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 revenue discount rate, which was 19.0%. The contingent consideration for future milestone payments related to the acquisition of miraDry is based on the timing of achievement of target net sales, which is estimated based on an internal management forecast. The significant assumption utilized in the fair value measurement was the miraDry company discount rate, which was 11.2%. As these inputs are not observable, the overall fair value measurement of the contingent consideration is classified as Level 3. During the quarter ended March 31, 2020, there were no material changes to the fair value of the contingent consideration.
Convertible note conversion feature
The Company assessed the fair value of the conversion feature related to the convertible note due in 2025. The conversion feature was bifurcated and recorded as a current derivative liability on the condensed consolidated balance sheet with a corresponding discount at the date of issuance that is netted against the principal amount of the note. The Company has utilized a binomial lattice method to determine the fair value of the conversion feature, which utilizes inputs including the common stock price, volatility of common stock, the risk-free interest rate and the probability of conversion to common shares at the Base Conversion Rate and in the event of a major transaction (e.g. a change in control). As the probability of conversion is a significant unobservable input, the overall fair value measurement of the conversion feature is classified as level 3.
12
The following tables present information about the Company’s liabilities that are measured at fair value on a recurring basis as of March 31, 2020 and December 31, 2019 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):
|
|
Fair Value Measurements as of
|
|
|
|
March 31, 2020 Using:
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability for contingent consideration
|
|
$
|
—
|
|
|
|
—
|
|
|
|
6,891
|
|
|
|
6,891
|
|
Liability for convertible note conversion feature
|
|
|
—
|
|
|
|
—
|
|
|
|
16,230
|
|
|
|
16,230
|
|
|
|
$
|
—
|
|
|
|
—
|
|
|
|
23,121
|
|
|
|
23,121
|
|
|
|
Fair Value Measurements as of
|
|
|
|
December 31, 2019 Using:
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability for common stock warrants
|
|
$
|
—
|
|
|
|
—
|
|
|
|
38
|
|
|
|
38
|
|
Liability for contingent consideration
|
|
|
—
|
|
|
|
—
|
|
|
|
6,891
|
|
|
|
6,891
|
|
|
|
$
|
—
|
|
|
|
—
|
|
|
|
6,929
|
|
|
|
6,929
|
|
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 sheet. The liability for the conversion feature related to the convertible note is included in “derivative liability” in the condensed consolidated balance sheet.
The Company recognizes changes in the fair value of the derivative liability in “other income (expense), net” in the condensed consolidated statement of operations and changes in the contingent consideration are recognized in “general and administrative” expense in the condensed consolidated statement of operations.
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 4 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):
|
|
Three Months Ended March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Balance as of January 1
|
|
$
|
1,562
|
|
|
$
|
1,395
|
|
Warranty costs incurred during the period
|
|
|
(185
|
)
|
|
|
(139
|
)
|
Changes in accrual related to warranties issued during the period
|
|
|
242
|
|
|
|
244
|
|
Changes in accrual related to pre-existing warranties
|
|
|
(6
|
)
|
|
|
29
|
|
Balance as of March 31
|
|
$
|
1,613
|
|
|
$
|
1,529
|
|
13
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 March 31,
|
|
|
|
2020
|
|
2019
|
|
Net loss (in thousands)
|
|
$
|
(28,612
|
)
|
|
$
|
(26,484
|
)
|
Weighted average common shares outstanding, basic and diluted
|
|
|
49,916,412
|
|
|
|
29,099,382
|
|
Net loss per share attributable to common stockholders
|
|
$
|
(0.57
|
)
|
|
$
|
(0.91
|
)
|
The Company excluded the following potentially dilutive securities, outstanding as of March 31, 2020 and 2019, from the computation of diluted net loss per share attributable to common stockholders for the three months ended March 31, 2020 and 2019 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.
|
|
March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Stock options to purchase common stock
|
|
|
1,590,903
|
|
|
|
1,907,938
|
|
Warrants for the purchase of common stock
|
|
|
32,375
|
|
|
|
47,710
|
|
Equity contingent consideration
|
|
|
607,442
|
|
|
|
—
|
|
Stock issuable upon conversion of convertible note
|
|
|
19,733,352
|
|
|
|
—
|
|
|
|
|
21,964,072
|
|
|
|
1,955,648
|
|
The Company uses the if-converted method for calculating any potential dilutive effects of the convertible note. The Company did not adjust the net loss for the quarter ended March 31, 2020 to eliminate any interest expense or gain/loss for the derivative liability related to the note in the computation of diluted loss per share, as the effects would be anti-dilutive. Further, the Company excluded from diluted weighted average shares approximately 14.6 million shares issuable upon conversion for the quarter ended March 31, 2020, as the effects would be anti-dilutive.
9.
|
Balance Sheet Components
|
Inventories, net consist of the following (in thousands):
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Raw materials
|
|
$
|
7,175
|
|
|
$
|
8,095
|
|
Work in progress
|
|
|
5,254
|
|
|
|
5,543
|
|
Finished goods
|
|
|
27,264
|
|
|
|
23,893
|
|
Finished goods - right of return
|
|
|
2,425
|
|
|
|
2,081
|
|
|
|
$
|
42,118
|
|
|
$
|
39,612
|
|
14
|
b.
|
Property and Equipment
|
Property and equipment, net consist of the following (in thousands):
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Leasehold improvements
|
|
$
|
2,857
|
|
|
$
|
2,841
|
|
Manufacturing equipment and toolings
|
|
|
8,481
|
|
|
|
8,175
|
|
Computer equipment
|
|
|
1,524
|
|
|
|
1,250
|
|
Software
|
|
|
2,652
|
|
|
|
2,602
|
|
Office equipment
|
|
|
129
|
|
|
|
111
|
|
Furniture and fixtures
|
|
|
1,162
|
|
|
|
1,144
|
|
|
|
|
16,805
|
|
|
|
16,123
|
|
Less accumulated depreciation
|
|
|
(4,461
|
)
|
|
|
(3,809
|
)
|
|
|
$
|
12,344
|
|
|
$
|
12,314
|
|
Depreciation expense for the three months ended March 31, 2020 and 2019 was $0.7 million and $0.3 million, respectively.
|
c.
|
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.
The changes in the carrying amount of goodwill during the three months ended March 31, 2020 and the year ended December 31, 2019 were as follows (in thousands):
|
|
Breast Products
|
|
|
miraDry
|
|
|
Total
|
|
Balances as of December 31, 2018
|
|
$
|
4,878
|
|
|
$
|
7,629
|
|
|
$
|
12,507
|
|
Goodwill acquired
|
|
|
4,324
|
|
|
|
—
|
|
|
|
4,324
|
|
Accumulated impairment losses
|
|
|
—
|
|
|
|
(7,629
|
)
|
|
|
(7,629
|
)
|
Balances as of December 31, 2019
|
|
$
|
9,202
|
|
|
$
|
—
|
|
|
$
|
9,202
|
|
Goodwill acquired
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Balances as of March 31, 2020
|
|
$
|
9,202
|
|
|
$
|
—
|
|
|
$
|
9,202
|
|
In the first quarter of 2020, the Company noted a decline in actual and forecasted earnings for the miraDry reporting unit due to the effects and uncertainty surrounding the COVID-19 pandemic. As a result, the Company performed a test of recoverability by comparing the carrying value of the reporting unit to the future undiscounted cash flows the reporting unit is expected to generate. As the future undiscounted cash flows attributable to the asset group 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 future cash flows derived from existing customers and requires the use of customer attrition rates and discount rates to determine the estimated fair value. The future revenues and free cash flow from existing customers are determined based upon actual results giving effect to management’s expected changes in operating results in future years. The attrition rate is based on average historical levels of customer attrition and the discount rate is based upon market participant assumptions using a defined peer group. 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. This method requires the use of royalty rates which are determined based on comparable third party license agreements involving similar assets and discount rates similar to the above to determine the estimated fair value.
15
After performing the impairment analysis as of March 31, 2020, 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 total non-cash impairment charges of $1.1 million for trade names, $1.4 million for developed technology, and $3.9 million for customer relationships within impairment in the accompanying condensed consolidated statement of operations for the quarter ended March 31, 2020. As March 31, 2020, the remaining carrying value of the intangible assets are entirely associated with the Breast Products segment.
The components of the Company’s other intangible assets consist of the following (in thousands):
|
|
Average
|
|
|
|
|
|
|
Amortization
|
|
|
March 31, 2020
|
|
|
|
Period
|
|
|
Gross Carrying
|
|
|
Accumulated
|
|
|
Intangible
|
|
|
|
(in years)
|
|
|
Amount
|
|
|
Amortization
|
|
|
Assets, net
|
|
Intangibles with definite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Customer relationships
|
|
|
10
|
|
|
$
|
4,940
|
|
|
$
|
(3,470
|
)
|
|
$
|
1,470
|
|
Trade names - finite life
|
|
|
12
|
|
|
|
800
|
|
|
|
(272
|
)
|
|
|
528
|
|
Non-compete agreement
|
|
|
2
|
|
|
|
80
|
|
|
|
(80
|
)
|
|
|
—
|
|
Regulatory approvals
|
|
|
1
|
|
|
|
670
|
|
|
|
(670
|
)
|
|
|
—
|
|
Acquired FDA non-gel product approval
|
|
|
11
|
|
|
|
1,713
|
|
|
|
(1,713
|
)
|
|
|
—
|
|
Manufacturing know-how
|
|
|
19
|
|
|
|
8,240
|
|
|
|
(305
|
)
|
|
|
7,935
|
|
Total definite-lived intangible assets
|
|
|
|
|
|
$
|
16,443
|
|
|
$
|
(6,510
|
)
|
|
$
|
9,933
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangibles with indefinite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade names - indefinite life
|
|
—
|
|
|
|
450
|
|
|
|
—
|
|
|
|
450
|
|
Total indefinite-lived intangible assets
|
|
|
|
|
|
$
|
450
|
|
|
$
|
—
|
|
|
$
|
450
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
December 31, 2019
|
|
|
|
Period
|
|
|
Gross Carrying
|
|
|
Accumulated
|
|
|
Intangible
|
|
|
|
(in years)
|
|
|
Amount
|
|
|
Amortization
|
|
|
Assets, net
|
|
Intangibles with definite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Customer relationships
|
|
|
11
|
|
|
$
|
9,540
|
|
|
$
|
(3,846
|
)
|
|
$
|
5,694
|
|
Trade names - finite life
|
|
|
14
|
|
|
|
2,000
|
|
|
|
(292
|
)
|
|
|
1,708
|
|
Developed technology
|
|
|
13
|
|
|
|
1,500
|
|
|
|
(84
|
)
|
|
|
1,416
|
|
Non-compete agreement
|
|
|
2
|
|
|
|
80
|
|
|
|
(80
|
)
|
|
|
—
|
|
Regulatory approvals
|
|
|
1
|
|
|
|
670
|
|
|
|
(670
|
)
|
|
|
—
|
|
Acquired FDA non-gel product approval
|
|
|
11
|
|
|
|
1,713
|
|
|
|
(1,713
|
)
|
|
|
—
|
|
Manufacturing know-how
|
|
|
19
|
|
|
|
8,240
|
|
|
|
(118
|
)
|
|
|
8,122
|
|
Total definite-lived intangible assets
|
|
|
|
|
|
$
|
23,743
|
|
|
$
|
(6,803
|
)
|
|
$
|
16,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangibles with indefinite lives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade names - indefinite life
|
|
—
|
|
|
|
450
|
|
|
|
—
|
|
|
|
450
|
|
Total indefinite-lived intangible assets
|
|
|
|
|
|
$
|
450
|
|
|
$
|
—
|
|
|
$
|
450
|
|
16
Amortization expense for the three months ended March 31, 2020 and 2019 was $0.6 million. The following table summarizes the estimated amortization expense relating to the Company's definite-lived intangible assets as of March 31, 2020 (in thousands):
|
|
Amortization
|
|
Period
|
|
Expense
|
|
2020
|
|
$
|
997
|
|
2021
|
|
|
1,221
|
|
2022
|
|
|
1,163
|
|
2023
|
|
|
1,092
|
|
2024
|
|
|
948
|
|
Thereafter
|
|
|
4,512
|
|
|
|
$
|
9,933
|
|
|
d.
|
Accrued and Other Current Liabilities
|
Accrued and other current liabilities consist of the following (in thousands):
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Payroll and related expenses
|
|
$
|
3,341
|
|
|
$
|
6,789
|
|
Accrued severance
|
|
|
1,904
|
|
|
|
894
|
|
Accrued commissions
|
|
|
3,830
|
|
|
|
4,984
|
|
Accrued equipment
|
|
|
116
|
|
|
|
400
|
|
Accrued inventory
|
|
|
525
|
|
|
|
2,216
|
|
Deferred and contingent consideration, current portion
|
|
|
6,830
|
|
|
|
6,830
|
|
Audit, consulting and legal fees
|
|
|
260
|
|
|
|
630
|
|
Accrued sales and marketing expenses
|
|
|
1,357
|
|
|
|
1,109
|
|
Operating lease liabilities
|
|
|
1,430
|
|
|
|
1,259
|
|
Finance lease liabilities
|
|
|
54
|
|
|
|
40
|
|
Other
|
|
|
6,755
|
|
|
|
7,400
|
|
|
|
$
|
26,402
|
|
|
$
|
32,551
|
|
The Company leases certain office space, warehouses, distribution facilities and office equipment. 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. 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.
17
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 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 March 31,
|
|
|
Three Months Ended March 31,
|
|
Lease Cost
|
|
Classification
|
|
2020
|
|
|
2019
|
|
Operating lease cost
|
|
Operating expenses
|
|
$
|
530
|
|
|
$
|
380
|
|
Operating lease cost
|
|
Inventory
|
|
|
—
|
|
|
|
1,248
|
|
Total operating lease cost
|
|
|
|
|
|
$
|
530
|
|
|
$
|
1,628
|
|
Finance lease cost
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of right-of-use assets
|
|
Operating expenses
|
|
|
14
|
|
|
|
9
|
|
Interest on lease liabilities
|
|
Other income (expense), net
|
|
|
2
|
|
|
|
1
|
|
Total finance lease cost
|
|
|
|
|
|
$
|
16
|
|
|
$
|
10
|
|
Variable lease cost
|
|
Inventory
|
|
|
—
|
|
|
|
2,373
|
|
Total lease cost
|
|
|
|
|
|
$
|
546
|
|
|
$
|
4,011
|
|
Short-term lease expense for both the three months ended March 31, 2020 and 2019 was not material.
Supplemental cash flow information related to operating and finance leases for the three months ended March 31, 2020 was as follows (in thousands):
|
|
Three Months Ended March 31,
|
|
|
Three Months Ended March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
|
|
|
|
|
|
Operating cash outflows from operating leases
|
|
$
|
487
|
|
|
$
|
1,462
|
|
Operating cash outflows from finance leases
|
|
|
14
|
|
|
|
9
|
|
Right-of-use assets obtained in exchange for lease obligations:
|
|
|
|
|
|
|
|
|
Operating leases
|
|
$
|
1,105
|
|
|
$
|
23,046
|
|
Finance leases
|
|
|
60
|
|
|
|
119
|
|
18
Supplemental balance sheet information, as of March 31, 2020, related to operating and finance leases was as follows (in thousands, except lease term and discount rate):
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Reported as:
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
|
|
|
|
|
|
Operating lease right-of-use assets
|
|
$
|
8,234
|
|
|
$
|
7,494
|
|
Finance lease right-of-use assets
|
|
|
124
|
|
|
|
78
|
|
Total right-of use assets
|
|
$
|
8,358
|
|
|
$
|
7,572
|
|
Accrued and other current liabilities
|
|
|
|
|
|
|
|
|
Operating lease liabilities
|
|
$
|
1,430
|
|
|
$
|
1,259
|
|
Finance lease liabilities
|
|
|
54
|
|
|
|
40
|
|
Warranty reserve and other long-term liabilities
|
|
|
|
|
|
|
|
|
Operating lease liabilities
|
|
|
7,005
|
|
|
|
6,434
|
|
Finance lease liabilities
|
|
|
69
|
|
|
|
35
|
|
Total lease liabilities
|
|
$
|
8,558
|
|
|
$
|
7,768
|
|
Weighted average remaining lease term (years)
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
5
|
|
|
|
5
|
|
Finance leases
|
|
|
3
|
|
|
|
2
|
|
Weighted average discount rate
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
7.70
|
%
|
|
|
7.45
|
%
|
Finance leases
|
|
|
5.42
|
%
|
|
|
4.06
|
%
|
As of March 31, 2020, maturities of the Company’s operating and finance lease liabilities are as follows (in thousands):
Period
|
|
Operating leases
|
|
|
Finance leases
|
|
|
Total
|
|
2020
|
|
$
|
1,560
|
|
|
$
|
45
|
|
|
$
|
1,605
|
|
2021
|
|
|
2,075
|
|
|
|
53
|
|
|
|
2,128
|
|
2022
|
|
|
1,893
|
|
|
|
17
|
|
|
|
1,910
|
|
2023
|
|
|
1,940
|
|
|
|
17
|
|
|
|
1,957
|
|
2024 and thereafter
|
|
|
2,974
|
|
|
|
1
|
|
|
|
2,975
|
|
Total lease payments
|
|
$
|
10,442
|
|
|
$
|
133
|
|
|
$
|
10,575
|
|
Less imputed interest
|
|
|
2,007
|
|
|
|
10
|
|
|
|
2,017
|
|
Total operating lease liabilities
|
|
$
|
8,435
|
|
|
$
|
123
|
|
|
$
|
8,558
|
|
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.
19
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 some or 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 March 31, 2020, there was $40.0 million outstanding related to the Restated Term Loans of which $25.0 million is presented in “Current portion of long-term debt” and $15 million is presented in “Long-term debt, net of current portion” on the condensed consolidated balance sheet as a result of the Company entering into the Second Amendment to Amended and Restated Credit and Security Agreement, by and among the Company, certain of the Company’s subsidiaries, the lenders party thereto and MidCap Financial Trust as agent, or the Debt Restructuring. Refer to Note 16 – Subsequent Events for further detail on the Debt Restructuring. As of March 31, 2020, the unamortized debt issuance costs on the Restated Term Loans was $1.6 million and are included as a reduction to debt in “Long-term debt, net of current portion” on the condensed consolidated balance sheet.
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 March 31, 2020, there were no borrowings outstanding under the Revolving Loan. As of March 31, 2020, the unamortized debt issuance costs related to the Revolving Loan was approximately $0.1 million and was included in “Other assets” on the condensed consolidated balance sheet. On May 11, 2020, in association with the Debt Restructuring, the Company entered in to the Second Amendment to Amended and Restated Credit and Security Agreement (Revolving Loan), by and among the Company, certain of the Company’s subsidiaries, the lenders party thereto and MidCap Financial Trust as agent (the “Revolving Amendment”). Refer to Note 16 – Subsequent Events for further detail on the Debt Restructuring.
The amortization of debt issuance costs on the Restated Term Loans and the Restated Revolving Loan for the three months ended March 31, 2020 and 2019 were $0.1 million, 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. In association with the Debt Restructuring on May 11, 2020, certain covenants in the Credit Agreements were amended. Refer to Note 16 – Subsequent Events for further detail on the Debt Restructuring.
20
Convertible Note
On March 11, 2020, the Company issued $60.0 million of unsecured and subordinated convertible notes with an interest rate of 4.00% (“Note”) to Deerfield Partners, L.P. (“Holder”) in order to fund ongoing operations. The Note matures on March 11, 2025, subject to earlier conversion by the option of the Holder at any time in whole or in part into common shares of the Company, for a period up to five years. Upon conversion by the Holder, the Company shall deliver, shares of the Company’s common stock at a conversion rate of 14,634 per $1,000 principal amount of the Note (which represents an initial conversion rate price of $4.10), or the Base Conversion Rate, in each case subject to customary anti-dilution adjustments. In addition to the typical anti-dilution adjustment, the Note also provides the Holder with additional consideration (“Make-Whole Provision”) beyond the settlement of the conversion obligation, in the event of a major transaction prior to maturity (e.g. a change in control). Upon conversion by the Holder in the event of a major transaction, the Company shall deliver, either cash, shares of the Company’s common stock or a combination of cash and common stock at the Base Conversion rate plus the additional consideration from the Make-Whole Provision. The $60.0 million principal amount of the Note is not payable until the maturity date of March 11, 2025, unless converted to equity earlier. The Company will pay interest in cash on the Note at 4.00% per annum, quarterly from July 1, 2020.
The conversion features in the outstanding convertible debt instrument are accounted for as a free-standing embedded derivative bifurcated from the principal balance of the Note, as (1) the conversion features are not clearly and closely related to the debt instrument and are not considered to be indexed to the Company’s equity, (2) the conversion features standing alone meet the definition of a derivative, and (3) the Note is not remeasured at fair value each reporting period with changes in fair value recorded in the condensed consolidated statement of operations.
The initial embedded derivative liability of $16.1 million was recorded as a non-current liability on the condensed consolidated balance sheet and is remeasured to fair value at each balance sheet date with a resulting non-cash gain or loss related to the change in the fair value being charged to earnings (loss). As of March 31, 2020, the fair value of the derivative liability was $16.2 million. A corresponding debt discount of $16.1 million and issuance costs of $1.5 million were recorded on the issuance date and is netted against the principal amount of the Note. As of March 31, 2020, the unamortized debt discount and issuance costs were $17.5 million. The Company will amortize the debt discount and debt issuance costs to interest expense under the effective interest method over the term of the Note, at a resulting effective interest rate of approximately 12%. For the quarter ended March 31, 2020, the amortization of the convertible debt discount and issuance costs were $0.2 million and were included in interest expense in the condensed consolidated statements of operations. The accrued interest on the outstanding principal amount of $60 million as of March 31, 2020 was $0.1 million and was included in “Accrued and other current liabilities” in the condensed consolidated balance sheet.
Future Principal Payments of Debt
The future schedule of principal payments for all outstanding debt as of March 31, 2020 was as follows (in thousands):
Fiscal Year
|
|
|
|
|
Remainder of 2020
|
|
$
|
25,000
|
|
2021
|
|
|
2,083
|
|
2022
|
|
|
5,000
|
|
2023
|
|
|
5,000
|
|
2024
|
|
|
2,917
|
|
Thereafter
|
|
|
60,000
|
|
Total
|
|
$
|
100,000
|
|
21
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 March 31, 2020 and December 31, 2019, 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, or the Original Warrants, 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. The warrants within Tranche A expired on January 17, 2020. As of March 31, 2020, there were warrants to purchase an aggregate of 32,375 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 March 31, 2020, a total of 2,347,664 shares of the Company’s common stock were available for issuance under the 2014 Plan.
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 and their affiliates in accordance with NASDAQ Stock Market Rule 5635(c)(4) as an inducement material to such individuals entering into employment with the Company. As of March 31, 2020, inducement grants for 1,412,083 shares of common stock have been awarded, and 749,276 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
22
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, 2019
|
|
|
1,880,846
|
|
|
$
|
7.42
|
|
|
|
5.48
|
|
Forfeited
|
|
|
(300,000
|
)
|
|
|
7.93
|
|
|
|
|
|
Balances at March 31, 2020
|
|
|
1,580,846
|
|
|
$
|
7.33
|
|
|
|
4.97
|
|
For stock-based awards the Company recognizes compensation expense based on the grant date fair value using the Black-Scholes option valuation model. There was no stock-based compensation expense related to stock options for the three months ended March 31, 2020. Stock-based compensation expense related to stock options was $0.2 million for the three months ended March 31, 2019. As of March 31, 2020, there were also no unrecognized compensation costs related to stock options.
|
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, 2019
|
|
|
2,232,956
|
|
|
$
|
11.99
|
|
Granted
|
|
|
768,663
|
|
|
|
5.88
|
|
Vested
|
|
|
(472,914
|
)
|
|
|
8.42
|
|
Forfeited
|
|
|
(291,222
|
)
|
|
|
3.50
|
|
Balances at March 31, 2020
|
|
|
2,237,483
|
|
|
$
|
11.75
|
|
Stock-based compensation expense for RSUs for the three months ended March 31, 2020 and 2019 was $1.9 million and $3.4 million, respectively. As of March 31, 2020, there was $12.2 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 1.70 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
23
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 three months ended March 31, 2020, employees purchased 113,615 shares of common stock at a weighted average price of $4.70 per share. As of March 31, 2020, the number of shares of common stock available for future issuance was 1,036,405.
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 and $0.2 million for the three months ended March 31, 2020 and 2019, respectively.
|
f.
|
Significant Modifications
|
During the three months ended March 31, 2020, there were no material modifications of equity awards. During the three months ended March 31, 2019, the Company recognized $0.4 million in incremental compensation cost resulting from entering into a consulting agreement with one former employee that resulted in the modification of their existing equity awards.
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 months ended March 31, 2020 and 2019.
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, Luxe, Curve, AlloX2, Dermaspan, Softspan and BIOCORNEUM. The miraDry segment, acquired on July 25, 2017, 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. miraDry has been included in the condensed consolidated results of operations as of the acquisition date and financial performance of the acquired business is reported in the miraDry segment. The Vesta Acquisition, completed on November 7, 2019, has been included in the condensed consolidated results of operations as of the acquisition date and financial performance of the acquired business is reported in the Breast Products segment.
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.
The following tables present the net sales, net operating loss and net assets by reportable segment for the periods presented (in thousands):
|
|
March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Net sales
|
|
|
|
|
|
|
|
|
Breast Products
|
|
$
|
12,471
|
|
|
$
|
9,751
|
|
miraDry
|
|
|
4,461
|
|
|
|
7,801
|
|
Total net sales
|
|
$
|
16,932
|
|
|
$
|
17,552
|
|
24
|
|
March 31,
|
|
|
|
2020
|
|
|
2019
|
|
Loss from operations
|
|
|
|
|
|
|
|
|
Breast Products
|
|
$
|
(12,363
|
)
|
|
$
|
(14,032
|
)
|
miraDry
|
|
|
(14,643
|
)
|
|
|
(11,819
|
)
|
Total loss from operations
|
|
$
|
(27,006
|
)
|
|
$
|
(25,851
|
)
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Assets
|
|
|
|
|
|
|
|
|
Breast Products
|
|
$
|
196,172
|
|
|
$
|
169,613
|
|
miraDry
|
|
|
26,674
|
|
|
|
34,791
|
|
Total assets
|
|
$
|
222,846
|
|
|
$
|
204,404
|
|
15.
|
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 is still pending before the Court. The Company intends to vigorously defend itself in this lawsuit. Given the nature of this case, the Company is unable to estimate the reasonably possible loss or range of loss, if any, arising from this matter.
CARES Act
On April 20, 2020, the Company was granted a loan of $6.7 million under the Paycheck Protection Program of the CARES Act, or the PPP Loan, from Silicon Valley Bank, or the Lender. The PPP Loan matures on April 20, 2022, or the Maturity Date, and bears interest at a rate of 1.0% per annum. Under the terms of the PPP Loan, the Company will make no payments during the six month period beginning on the date of the loan, or the Deferral Period. Commencing one month after the expiration of the Deferral Period, and continuing on the same day of each month thereafter until the Maturity Date, the Company will pay to Lender monthly payments of principal and interest, each in such equal amount required to fully amortize the principal amount outstanding on the PPP Loan on the last day of the Deferral Period by the Maturity Date.
25
All or a portion of the PPP Loan may be forgiven upon application by the Company beginning 60 days, but not later than 120 days, after loan approval and upon documentation of expenditures in accordance with certain specified requirements. Under the CARES Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the eight week period beginning on the date of loan approval. Not more than 25% of the forgiven amount may be for non-payroll costs. The amount of the PPP Loan eligible to be forgiven will be reduced if the Company’s full-time headcount declines, or if salaries and wages for employees with salaries of $100,000 or less annually are reduced by more than 25%. The Company will be required to repay any portion of the outstanding principal that is not forgiven, along with accrued interest, in accordance with the amortization schedule described above.
Debt Restructuring
On May 11, 2020, the Company entered in to the Second Amendment to Amended and Restated Credit and Security Agreement (Term Loan) (the “Term Agreement”), by and among the Company, certain of the Company’s subsidiaries, the lenders party thereto and MidCap Financial Trust as agent (the “Term Amendment”). The Term Amendment provides for, among other things, the prepayment by the Company of approximately $25.0 million of outstanding principal plus accrued interest, with the parties agreeing to waive the prepayment fee with respect to this amount. In connection with the prepayment, the Term Amendment requires the Company to prepay $1.25 million of the exit fee under the Term Agreement. The Term Amendment increases the tranche 3 commitment amount from $10.0 million to $15.0 million, extends the tranche 3 termination date from December 31, 2020 to June 30, 2021, and amends certain conditions upon which the tranche 3 commitment can be withdrawn, including evidence that the Company’s Net Revenue for the past six months was greater than or equal to $30.0 million. In addition, the Term Amendment amends certain financial requirements including reducing the Company’s minimum unrestricted cash amount from $20.0 million to $5.0 million and amends certain minimum net revenue requirements. Further, the monthly minimum net revenue requirements were revised to be calculated on a trailing three month basis. On May 11, 2020, the Company prepaid $25.0 million of principal, $1.25 million of the exit fee, and $0.1 million of accrued interest.
In addition, on May 11, 2020, the Company entered in to the Second Amendment to Amended and Restated Credit and Security Agreement (Revolving Loan), by and among the Company, certain of the Company’s subsidiaries, the lenders party thereto and MidCap Financial Trust as agent (the “Revolving Amendment”). The Revolving Amendment includes conforming changes to reflect the changes in the Term Amendment. In addition, the Revolving Amendment reduces the borrowing base by the portion of the eligible inventory previously included in the calculation.
26