SIENTRA, INC., 10-Q filed on 8/9/2017
Quarterly Report
Document and Entity Information
6 Months Ended
Jun. 30, 2017
Aug. 4, 2017
Document And Entity Information [Abstract]
 
 
Entity Registrant Name
Sientra, Inc. 
 
Entity Central Index Key
0001551693 
 
Document Type
10-Q 
 
Document Period End Date
Jun. 30, 2017 
 
Amendment Flag
false 
 
Current Fiscal Year End Date
--12-31 
 
Entity Current Reporting Status
Yes 
 
Entity Filer Category
Accelerated Filer 
 
Entity Common Stock, Shares Outstanding
 
19,306,854 
Document Fiscal Year Focus
2017 
 
Document Fiscal Period Focus
Q2 
 
Trading Symbol
SIEN 
 
Condensed Balance Sheets (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Current assets:
 
 
Cash and cash equivalents
$ 55,495 
$ 67,212 
Accounts receivable, net of allowances of $4,532 and $4,329 at June 30, 2017 and December 31, 2016, respectively
3,007 
3,082 
Inventories, net
16,401 
18,484 
Insurance recovery receivable
97 
9,375 
Prepaid expenses and other current assets
3,401 
1,852 
Total current assets
78,401 
100,005 
Property and equipment, net
3,788 
2,986 
Goodwill
4,878 
4,878 
Other intangible assets, net
5,332 
6,186 
Other assets
1,226 
228 
Total assets
93,625 
114,283 
Current liabilities:
 
 
Current portion of long-term debt
5,000 
 
Accounts payable
2,256 
3,555 
Accrued and other current liabilities
10,354 
6,507 
Legal settlement payable
10,000 
10,900 
Customer deposits
5,862 
6,559 
Total current liabilities
33,472 
27,521 
Warranty reserve and other long-term liabilities
4,315 
3,145 
Total liabilities
37,787 
30,666 
Commitments and contingencies (Note 12)
   
   
Stockholders’ equity:
 
 
Preferred stock, $0.01 par value – Authorized 10,000,000 shares; none issued or outstanding
   
   
Common stock, $0.01 par value — Authorized 200,000,000 shares; issued 19,325,332 and 18,671,409 and outstanding 19,252,605 and 18,598,682 shares at June 30, 2017 and December 31, 2016 respectively
193 
186 
Additional paid-in capital
303,159 
299,133 
Treasury stock, at cost (72,727 shares at June 30, 2017 and December 31, 2016)
(260)
(260)
Accumulated deficit
(247,254)
(215,442)
Total stockholders’ equity
55,838 
83,617 
Total liabilities and stockholders’ equity
$ 93,625 
$ 114,283 
Condensed Balance Sheets (Parenthetical) (USD $)
In Thousands, except Share data, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Statement Of Financial Position [Abstract]
 
 
Accounts receivable, allowances (in dollars)
$ 4,532 
$ 4,329 
Preferred stock, par value (in dollars per share)
$ 0.01 
$ 0.01 
Preferred stock, shares authorized
10,000,000 
10,000,000 
Preferred stock, shares issued
Preferred stock, shares outstanding
Common stock, par value (in dollars per share)
$ 0.01 
$ 0.01 
Common stock, shares authorized
200,000,000 
200,000,000 
Common stock, shares issued
19,325,332 
18,671,409 
Common stock, shares outstanding
19,252,605 
18,598,682 
Treasury stock, shares
72,727 
72,727 
Condensed Statements of Operations (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Income Statement [Abstract]
 
 
 
 
Net sales
$ 8,169,000 
$ 6,244,000 
$ 15,658,000 
$ 7,715,000 
Cost of goods sold
2,621,000 
1,745,000 
4,942,000 
2,506,000 
Gross profit
5,548,000 
4,499,000 
10,716,000 
5,209,000 
Operating expenses:
 
 
 
 
Sales and marketing
6,163,000 
6,287,000 
13,119,000 
11,396,000 
Research and development
1,573,000 
3,062,000 
4,766,000 
5,317,000 
General and administrative
8,022,000 
5,357,000 
14,458,000 
10,642,000 
Legal settlement
10,000,000 
 
10,000,000 
 
Total operating expenses
25,758,000 
14,706,000 
42,343,000 
27,355,000 
Loss from operations
(20,210,000)
(10,207,000)
(31,627,000)
(22,146,000)
Other income (expense), net:
 
 
 
 
Interest income
37,000 
16,000 
59,000 
31,000 
Interest expense
(185,000)
(12,000)
(194,000)
(13,000)
Other income (expense), net
(4,000)
10,000 
4,000 
(2,000)
Total other income (expense), net
(152,000)
14,000 
(131,000)
16,000 
Loss before income taxes
(20,362,000)
(10,193,000)
(31,758,000)
(22,130,000)
Income taxes
29,000 
54,000 
Net loss
$ (20,391,000)
$ (10,193,000)
$ (31,812,000)
$ (22,130,000)
Basic and diluted net loss per share attributable to common stockholders
$ (1.07)
$ (0.56)
$ (1.68)
$ (1.23)
Weighted average outstanding common shares used for net loss per share attributable to common stockholders:
 
 
 
 
Basic and diluted
19,132,052 
18,075,010 
18,953,500 
18,062,803 
Condensed Statements of Cash Flows (USD $)
In Thousands, unless otherwise specified
6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Cash flows from operating activities:
 
 
Net loss
$ (31,812)
$ (22,130)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
Depreciation and amortization
1,159 
425 
Provision for doubtful accounts
27 
331 
Provision for warranties
119 
74 
Provision for inventory
367 
391 
Change in fair value of warrants
83 
Change in fair value of deferred and contingent consideration
449 
 
Non-cash interest expense
144 
12 
Stock-based compensation expense
3,182 
1,664 
Loss on disposal of property and equipment
12 
122 
Deferred income taxes
54 
 
Changes in assets and liabilities:
 
 
Accounts receivable
47 
1,514 
Prepaid expenses, other current assets and other assets
(2,395)
(574)
Inventories
1,716 
1,406 
Insurance recovery receivable
9,277 
 
Accounts payable
(1,264)
(635)
Accrued and other liabilities
4,648 
428 
Legal settlement payable
(900)
 
Customer deposits
(697)
(2,530)
Net cash used in operating activities
(15,784)
(19,496)
Cash flows from investing activities:
 
 
Purchase of property and equipment
(1,580)
(874)
Business acquisitions
 
(6,759)
Net cash used in investing activities
(1,580)
(7,633)
Cash flows from financing activities:
 
 
Proceeds from exercise of stock options
1,096 
57 
Proceeds from issuance of common stock under ESPP
324 
430 
Tax payments related to shares withheld for vested restricted stock units (RSUs)
(569)
 
Gross borrowings under the Revolving Line of Credit
5,000 
 
Deferred financing costs
(204)
 
Net cash provided by financing activities
5,647 
487 
Net decrease in cash and cash equivalents
(11,717)
(26,642)
Cash and cash equivalents at:
 
 
Beginning of period
67,212 
112,801 
End of period
55,495 
86,159 
Supplemental disclosure of cash flow information:
 
 
Interest paid
50 
 
Supplemental disclosure of non-cash investing and financing activities:
 
 
Property and equipment in accounts payable and accrued liabilities
461 
 
Acquisition of business, deferred and contingent consideration obligations at fair value
 
$ 550 
Formation and Business of the Company
Formation and Business of the Company

1.

Formation and Business of the Company

 

a.

Formation

Sientra, Inc., or the Company, 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 premarket approval, or PMA, assets. Following this acquisition, the Company focused on completing the clinical trials to gain Food and Drug Administration, or FDA, approval to offer its silicone gel breast implants in the United States.

In March 2012, Sientra 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 Inquiries Regarding Products Manufactured by Silimed

There have been regulatory inquiries related to medical devices manufactured by Silimed Indústria de Implantes Ltda. (formerly, Silimed-Silicone e Instrumental Medico-Cirugio e Hospitalar Ltda.), or Silimed, the Company’s former sole source contract manufacturer for its silicone gel breast implants.

On September 23, 2015, the Medicines and Healthcare Products Regulatory Agency, or MHRA, an executive agency of the United Kingdom, or U.K., announced the suspension of sales and implanting in the U.K. of all medical devices manufactured by Silimed following the suspension of the CE and ISO 13485 certifications of these products issued by TÜV SÜD, Silimed’s notified body under European Union, or EU, regulation. The suspension followed TÜV SÜD’s inspection at Silimed’s manufacturing facilities in Brazil, relating to the alleged presence of surface particles on Silimed breast products.

On October 2, 2015, the Brazilian regulatory agency ANVISA and the Department of the Secretary of State of the State of Rio de Janeiro announced the suspension of the manufacturing and shipment of all medical devices made by Silimed, including products manufactured for Sientra, while they reviewed the technical compliance related to current good manufacturing practices, or cGMP, of Silimed’s manufacturing facilities.

On October 9, 2015, the Company voluntarily placed a hold on the sale of all Sientra devices manufactured by Silimed and recommended that plastic surgeons discontinue implanting the devices until further notice. 

On January 27, 2016, after completing an analysis and risk assessment, ANVISA announced its authorization of Silimed to resume the commercialization and use of its previously manufactured products.  ANVISA concluded there was no evidence that the presence of surface particles on silicone implants represented risks which are additional to those inherent in the product.  

On March 1, 2016, after the completion of extensive independent, third-party testing and analyses of its devices manufactured by Silimed, the Company lifted the temporary hold on the sale of such devices and informed its Plastic Surgeons of the Company’s controlled market re-entry plan designed to optimize the Company’s inventory supply. The results of the Company’s testing indicated no significant safety concerns with the use of its products, including its breast implants, consistent with their approval status since 2012.  Additionally, the FDA reiterated prior statements of MHRA and ANVISA that no reports of adverse events and no risks to patient health had been identified in connection with implanting Silimed-manufactured products.

On July 11, 2016, after completing an inspection of Silimed’s facility, ANVISA announced the reinstatement of Silimed’s GMP certificate, valid for two years, and their ability to manufacture commercial products. The Silimed facility that was approved for manufacturing is a different facility from where Sientra breast implants were previously manufactured, which was damaged by a fire on October 22, 2015. The suspension of Silimed’s CE and ISO 13485 certifications by TÜV SÜD remains in place. The Company’s existing manufacturing contract with Silimed expired on its terms in April 2017 and the Company did not renew the contract.

For more information on the status of the Company’s relationship with Silimed, see Note 12 – Commitments and Contingencies.  

Summary of Significant Accounting Policies
Summary of Significant Accounting Policies

2.

Summary of Significant Accounting Policies

 

a.

Basis of Presentation

The accompanying unaudited condensed 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 financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 14, 2017, or the Annual Report. The results for the three and six months ended June 30, 2017 are not necessarily indicative of results to be expected for the year ending December 31, 2017, any other interim periods, or any future year or period.

 

b.

Going Concern  

The accompanying 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. The Company’s manufacturing contract with Silimed, expired on its terms on April 1, 2017, and the Company did not renew that contract.  Accordingly, the Company continues to evaluate the availability of alternative manufacturing sources, including with Vesta Intermediate Funding, Inc., or Vesta, a Lubrizol Lifesciences company, which is establishing manufacturing capacity for the Company and with which the Company executed a definitive manufacturing agreement for the long-term supply of the Company’s PMA-approved breast implants. The continuation of the Company as a going concern is dependent upon many factors including resolution of any outstanding disputes with Silimed (see Note 12—Commitments and Contingencies), the availability of alternative manufacturing sources, and continued sale of the Company’s products. Since inception, the Company has incurred net losses. As of June 30, 2017, the Company had cash and cash equivalents of $55.5 million. Furthermore, through the Loan and Security Agreement, Silicon Valley bank made available to the Company a revolving line of credit of up to $15.0 million, or the Revolving Line, and a $5.0 million term loan, or the Term Loan. The Company believes that it has the ability to continue as a going concern for at least 12 months from the date the Company’s financial statements are issued. These financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

On July 25, 2017, the Company acquired Miramar Labs, Inc. and also entered into certain credit agreements with Midcap Financial Trust (see Subsequent Events – Acquisition of Miramar Labs and Credit Agreements with MidCap Financial Trust for more information).

 

c.

Use of Estimates

The preparation of the condensed 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 financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

 

d.

Significant Accounting Policies

There have been no significant changes to the accounting policies during the three and six months ended June 30, 2017, as compared to the significant accounting policies described in the “Notes to Financial Statements” in the Annual Report.

 

e.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

In July 2015, the FASB issued accounting standard update, or ASU, 2015-11, Inventory - Simplifying the Measurement of Inventory.  The standard simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. The accounting standards update will not apply to inventories that are measured by using either the last-in, first-out method or the retail inventory method. The Company adopted ASU 2015-11 in the first quarter of 2017 on a prospective basis. The adoption of this ASU did not have a material impact on the Company’s financial statements.

 

In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718). The standard identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. The Company adopted ASU 2016-09 in the first quarter of 2017 on a prospective basis. The Company has made an accounting policy election to account for forfeitures when they occur. The adoption of this ASU did not have a material impact on the Company’s financial statements.

 

In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350) - Simplifying the Test for Goodwill Impairment. The standard update eliminates Step 2 from the goodwill impairment test. The guidance requires an entity to perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value. In addition, the guidance eliminates the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment. The standard will be effective for the Company beginning in fiscal year 2020. Early adoption is permitted for interim and annual goodwill impairment tests performed after January 1, 2017. The Company adopted ASU 2017-04 in the first quarter of 2017 on a prospective basis. The adoption of this ASU did not have a material impact on the Company’s financial statements. The Company will reassess any impact at year end

Recently Issued Accounting Standards

 

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers.  The standard was issued to provide a single framework that replaces existing industry and transaction specific GAAP with a five step analysis of transactions to determine when and how revenue is recognized. The accounting standard update will replace most existing revenue recognition guidance in GAAP when it becomes effective. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, to defer the effective date of ASU 2014-09 by one year.  Therefore, ASU 2014-09 will become effective for the Company beginning in fiscal year 2018. Early adoption would be permitted for the Company beginning in fiscal year 2017. The standard permits the use of either the retrospective or cumulative transition method.  In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. ASU 2016-20 is intended to clarify and suggest improvements to the application of current standards under Topic 606 and other Topics amended by ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The effective date of ASU 2016-20 is the same as the effective date for ASU 2014-09. In preparation for our adoption of the new standard in our fiscal year ending December 31, 2018, we are reviewing contracts and other forms of agreements with our customers and are evaluating the provisions contained therein in light of the five-step model specified by the new guidance. That five-step model includes: (1) determination of whether a contract—an agreement between two or more parties that creates legally enforceable rights and obligations—exists; (2) identification of the performance obligations in the contract; (3) determination of the transaction price; (4) allocation of the transaction price to the performance obligations in the contract; and (5) recognition of revenue when (or as) the performance obligation is satisfied. We are also evaluating the impact of the new standard on certain common practices currently employed by us and by other medical device companies, such as allowance for sales returns, rebates, warranty and other pricing programs. We have not yet determined the impact of the new standard on our financial statements or whether we will adopt on a prospective or retrospective basis in the first quarter of our fiscal year ending December 31, 2018.

 

In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805) - Clarifying the Definition of a Business. The standard adds guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses by providing a more specific definition of a business. The updated accounting standard will be effective for the Company beginning in fiscal year 2018. The Company will evaluate the impact of this ASU on future acquisitions.

 

In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting. The standard provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award to which an entity would be required to apply modification accounting under ASC 718. The ASU is effective for the Company beginning in fiscal year 2018. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements and related disclosures.

 

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815). The standard is broken in to two parts. Part I addresses the complexity of accounting for certain financial instruments with down round features. Part II addresses the difficulty of navigating Topic 480 because of the existence of extensive pending content in the FASB Accounting Standards Codification. The ASU is effective for the Company beginning in fiscal year 2019. We have not yet determined the impact of the new standard on our financial statements.

Acquisitions
Acquisitions

3.

Acquisitions

 

a.

Acquisition of BIOCORNEUM®

On March 9, 2016, the Company entered into an assets purchase agreement with Enaltus LLC, or Enaltus, to acquire exclusive U.S. rights to BIOCORNEUM®, an advanced silicone scar treatment marketed exclusively to physicians. The acquisition of BIOCORNEUM® aligns with the Company’s business development objectives and adds a complementary product that serves the needs of its customers. In connection with the acquisition, the Company recorded  $0.0 and $0.2 million of professional fees for the three and six months ended June 30, 2016, respectively, which are included in general and administrative expense. The company did not record any professional fees related to the acquisition for the three and six months ended June 30, 2017. The aggregate acquisition date fair value of the consideration transferred was estimated at $7.4 million, which consisted of the following (in thousands):

 

 

 

Fair Value

 

Cash

 

$

6,859

 

Deferred consideration

 

 

434

 

Contingent consideration

 

 

116

 

 

 

$

7,409

 

 

The deferred consideration and contingent consideration consist of future royalty payments to be paid on a quarterly basis to Enaltus on future BIOCORNEUM® sales for the 4.5 years beginning January 1, 2024. The Company has determined the fair value of the deferred consideration and contingent consideration at the acquisition date using a Monte Carlo simulation model. The fair value of the deferred consideration is based on the future minimum royalty payments using the risk-free U.S. Treasury yield curve discount rate. The minimum estimated future payments due under the deferred consideration are $0.5 million. The fair value of the contingent consideration is based on projected future BIOCORNEUM® sales and a risk adjusted discount rate. The terms of the agreement do not provide for a limitation on the maximum potential future payments. The inputs are significant inputs not observable in the market, which are referred to as Level 3 inputs and are further discussed in Note 5. The deferred consideration and contingent consideration components are classified as other long-term liability and are subject to the recognition of subsequent changes in fair value through general and administrative expense in the statement of operations.

The Company allocated the total consideration transferred to the tangible and identifiable intangible assets acquired based on their respective fair values on the acquisition date, with the remaining unallocated amount recorded as goodwill. The goodwill arising from the transaction is primarily attributable to expected operational synergies, and all of goodwill will be deductible for income tax purposes. The condensed financial statements for the three and six months ended June 30, 2017 and 2016 include the results of operations of BIOCORNEUM® from the date of acquisition.

The following table summarizes the allocation of the fair value of the consideration transferred by major class for the business combination completed on March 9, 2016 (in thousands):

 

 

 

March 9,

 

 

 

2016

 

Inventory

 

$

100

 

Prepaid expenses

 

 

36

 

Goodwill

 

 

3,273

 

Intangible assets

 

 

4,000

 

 

 

$

7,409

 

 

A summary of the intangible assets acquired, estimated useful lives and amortization method is as follows (in thousands):

 

 

 

 

 

 

 

Estimated useful

 

 

Amortization

 

 

Amount

 

 

life (in years)

 

 

method

Customer relationships

 

$

3,200

 

 

 

10

 

 

Accelerated

Trade name

 

 

800

 

 

 

12

 

 

Straight-line

 

 

$

4,000

 

 

 

 

 

 

 

 

The Company retained an independent third-party appraiser to assist management in its valuation and the purchase price has been finalized. Pro forma results of operations have not been presented because the effect of the acquisition was not material to the Company's results of operations.

 

b.

Acquisition of Tissue Expander Portfolio from Specialty Surgical Products, Inc.

On November 2, 2016, the Company entered into an asset purchase agreement with Specialty Surgical Products, Inc., or SSP, to acquire certain assets, consisting of the Dermaspan™, Softspan™, and AlloX2® tissue expanders, from SSP. The acquisition adds a complete portfolio of premium, differentiated tissue expanders and aligns with the Company’s business development plans for growth in the breast reconstruction market. The Company did not record any professional fees for the three and six months ended June 30, 2017 and 2016 in connection with the acquisition. The aggregate preliminary acquisition date fair value of the consideration transferred was estimated at $6.0 million, which consisted of the following (in thousands):

 

 

 

Fair Value

 

Cash

 

$

4,950

 

Contingent consideration

 

 

1,050

 

 

 

$

6,000

 

 

The contingent consideration consists of future cash payments of a maximum of $2.0 million to be paid to SSP based upon the achievement of certain milestones of future net sales. The Company has determined the fair value of the contingent consideration at the acquisition date using a Monte-Carlo simulation model. The inputs include the estimated amount and timing of future net sales, and a risk-adjusted discount rate. The inputs are significant inputs not observable in the market, which are referred to as Level 3 inputs and are further discussed in Note 5. The contingent consideration components are classified as other long-term liabilities and are subject to the recognition of subsequent changes in fair value through general and administrative expense in the statement of operations.

The Company allocated the total consideration transferred to the tangible and identifiable intangible assets acquired and liabilities assumed based on their respective fair values on the acquisition date, with the remaining unallocated amount recorded as goodwill. The goodwill arising from the transaction is primarily attributable to expected operational synergies, and all of goodwill will be deductible for income tax purposes. The financial statements for the three and six months ended June 30, 2017 include the results of operations of the Dermaspan™, Softspan™, and AlloX2® tissue expanders.

The following table summarizes the allocation of the fair value of the consideration transferred by major class for the business combination completed on November 2, 2016 (in thousands):

 

 

 

November 2,

 

 

 

2016

 

Accounts receivable, net

 

$

196

 

Inventory

 

 

1,555

 

Equipment

 

 

34

 

Goodwill

 

 

1,605

 

Intangible assets

 

 

2,860

 

Liabilities assumed

 

 

(250

)

 

 

$

6,000

 

 

A summary of the intangible assets acquired, estimated useful lives and amortization method is as follows (in thousands):

 

 

 

 

 

 

 

Estimated useful

 

Amortization

 

 

Amount

 

 

life

 

method

Customer relationships

 

$

1,740

 

 

9 years

 

Accelerated

Regulatory approvals

 

 

670

 

 

14 months

 

Straight-line

Trade names

 

 

450

 

 

indefinite-lived

 

 

 

 

$

2,860

 

 

 

 

 

 

The Company retained an independent third-party appraiser to assist management in its valuation; however, the purchase price allocation has not been finalized. The primary areas of the preliminary purchase price allocation that are not yet finalized relate to the fair values of certain tangible assets and liabilities acquired, the valuation of intangible assets acquired, and residual goodwill. The Company expects to continue to obtain information to assist in determining the fair value of the net assets acquired at the acquisition date during the measurement period. The preliminary allocation of the purchase price is based on the best estimates of management and is subject to revision based on the final valuations and estimates of useful lives.

Pro forma results of operations have not been presented because the effect of the acquisition was not material to the Company's results of operations.  

 

c.

Acquisition Miramar Labs

 

On July 25, 2017, the Company acquired Miramar Labs, Inc. (see Note 13 – Subsequent Events – Acquisition of Miramar Labs).

Fair Value of Financial Instruments
Fair Value of Financial Instruments

4.

Fair Value of Financial Instruments

The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, and customer deposits are reasonable estimates of their fair value because of the short maturity of these items. See Note 5 for discussion of the fair value of the common stock warrant liability, deferred consideration and contingent consideration.  As of June 30, 2017, the Company had no outstanding long-term debt.

Fair Value Measurements
Fair Value Measurements

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.

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 historically has been a private company and lacks company-specific historical and implied volatility information of its stock. Therefore, it estimates its expected stock volatility based on the historical volatility of publicly traded peer companies for a term equal to the remaining contractual term of the warrants. 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 deferred consideration and contingent consideration for future royalty payments related to the acquisition of BIOCORNEUM® and the contingent consideration for future milestone payments for the acquisition of the tissue expander portfolio from SSP using the 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 deferred consideration and 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 June 30, 2017 and December 31, 2016 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):

 

 

 

Fair Value Measurements as of

 

 

 

June 30, 2017 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liability for common stock warrants

 

$

 

 

 

 

 

 

182

 

 

 

182

 

Liability for deferred consideration

 

 

 

 

 

 

 

 

381

 

 

 

381

 

Liability for contingent consideration

 

 

 

 

 

 

 

 

1,705

 

 

 

1,705

 

 

 

$

 

 

 

 

 

 

2,268

 

 

 

2,268

 

 

 

 

Fair Value Measurements as of

 

 

 

December 31, 2016 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liability for common stock warrants

 

$

 

 

 

 

 

 

99

 

 

 

99

 

Liability for deferred consideration

 

 

 

 

 

 

 

 

395

 

 

 

395

 

Liability for contingent consideration

 

 

 

 

 

 

 

 

1,242

 

 

 

1,242

 

 

 

$

 

 

 

 

 

 

1,736

 

 

 

1,736

 

 

The liability for common stock warrants is included in “accrued and other current liabilities” and the liability for the deferred consideration and contingent consideration is included in “warranty reserve and other long-term liabilities” in the balance sheet. The following table provides a rollforward of the aggregate fair values of the Company’s common stock warrants, deferred and contingent consideration for which fair value is determined by Level 3 inputs (in thousands):

 

Warrant Liability

 

 

 

 

Balance, December 31, 2016

 

$

99

 

Fair value of warrants to be issued upon borrowing under the Silicon Valley Bank term loan

   (Note 9)

 

 

88

 

Change in fair value through June 30, 2017

 

 

(5

)

Balance, June 30, 2017

 

$

182

 

Deferred Consideration Liability

 

 

 

 

Balance, December 31, 2016

 

$

395

 

Change in fair value of deferred consideration

 

 

(14

)

Balance, June 30, 2017

 

$

381

 

Contingent Consideration Liability

 

 

 

 

Balance, December 31, 2016

 

$

1,242

 

Change in fair value of contingent consideration

 

 

463

 

Balance, June 30, 2017

 

$

1,705

 

 

The Company recognizes changes in the fair value of the warrants in “other income (expense), net” in the statement of operations and changes in deferred consideration and contingent consideration are recognized in “general and administrative” expense in the statement of operations.

Product Warranties
Product Warranties

6.

Product Warranties

The Company offers a limited warranty and a lifetime product replacement program for the Company’s silicone gel breast implants. Under the limited warranty, the Company will reimburse patients for certain out-of-pocket costs related to revision surgeries performed within ten years from the date of implantation in a covered event. Under the lifetime product replacement program, the Company provides no-charge replacement breast implants if a patient experiences a covered event. The programs are available to all patients implanted with the Company’s silicone breast implants after April 1, 2012 and are subject to the terms, conditions, claim procedures, limitations and exclusions. Timely completion of a device tracking and warranty enrollment form by the patient’s Plastic Surgeon is required to activate the programs and for the patient to be able to receive benefits under either program.

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

 

 

 

Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

Beginning balance as of January 1

 

$

1,378

 

 

$

1,332

 

Payments made during the period

 

 

 

 

 

(9

)

Changes in accrual related to warranties issued during the period

 

 

110

 

 

 

76

 

Changes in accrual related to pre-existing warranties

 

 

9

 

 

 

(2

)

Balance as of June 30

 

$

1,497

 

 

$

1,397

 

 

Net Loss Per Share
Net Loss Per Share

7.

Net Loss Per Share

Basic net loss per share attributable to common stockholders is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted net loss per 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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Net loss (in thousands)

 

$

 

(20,391

)

 

$

 

(10,193

)

 

$

(31,812

)

 

$

(22,130

)

Weighted average common shares outstanding, basic

   and diluted

 

 

 

19,132,052

 

 

 

 

18,075,010

 

 

 

18,953,500

 

 

 

18,062,803

 

Net loss per share attributable to common stockholders

 

$

 

(1.07

)

 

$

 

(0.56

)

 

$

(1.68

)

 

$

(1.23

)

 

The Company excluded the following potentially dilutive securities, outstanding as of June 30, 2017 and 2016, from the computation of diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2017 and 2016 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.

 

 

 

June 30,

 

 

 

2017

 

 

2016

 

Stock options to purchase common stock

 

 

1,663,890

 

 

 

2,190,866

 

Warrants for the purchase of common stock

 

 

47,710

 

 

 

47,710

 

 

 

 

1,711,600

 

 

 

2,238,576

 

 

Balance Sheet Components
Balance Sheet Components

8.

Balance Sheet Components

 

a.

Allowance for Sales Returns and Doubtful Accounts

The Company has established an allowance for sales returns of $4.1 million and $3.9 million as of June 30, 2017 and December 31, 2016, respectively, recorded net against accounts receivable in the balance sheet.

 

The Company has established an allowance for doubtful accounts of $0.4 million and $0.4 million as of June 30, 2017 and December 31, 2016, respectively, recorded net against accounts receivable in the balance sheet.

 

b.

Property and Equipment

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

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Leasehold improvements

 

$

96

 

 

$

86

 

Laboratory equipment and toolings

 

 

3,273

 

 

 

2,264

 

Computer equipment

 

 

308

 

 

 

287

 

Software

 

 

719

 

 

 

669

 

Office equipment

 

 

130

 

 

 

129

 

Furniture and fixtures

 

 

757

 

 

 

743

 

 

 

 

5,283

 

 

 

4,178

 

Less accumulated depreciation

 

 

(1,495

)

 

 

(1,192

)

 

 

$

3,788

 

 

$

2,986

 

 

Depreciation expense for the three months ended June 30, 2017 and 2016 was $0.2 million and $0.1 million, respectively. Depreciation expense for the six months ended June 30, 2017 and 2016 was $0.3 million and $0.1 million, respectively.

 

c.

Goodwill and Other Intangible Assets, net

Goodwill represents the excess of the purchase price over the fair value of net assets of purchased businesses. Goodwill is not amortized, but instead subject to impairment tests on at least an annual basis and whenever circumstances suggest that goodwill may be impaired.  The Company’s annual test for impairment is performed as of October 1 of each fiscal year. The Company makes a qualitative assessment of whether it is more likely than not that a reporting unit’s fair value is less than its carrying amount. If the Company concludes that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, it is not required to perform the impairment assessment for that reporting unit.

The Guidance requires the Company to compare the fair value of a reporting unit with its carrying amount, including goodwill. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is not considered impaired. The impairment loss is measured by the excess of the carrying amount of the reporting unit goodwill over the fair value of that goodwill.

The changes in the carrying amount of goodwill during the six months ended June 30, 2017 were as follows (in thousands):

 

Balances as of December 31, 2016

 

 

 

 

Goodwill

 

$

19,156

 

Accumulated impairment losses

 

 

(14,278

)

Goodwill, net

 

$

4,878

 

Balances as of June 30, 2017

 

 

 

 

Goodwill

 

$

19,156

 

Accumulated impairment losses

 

 

(14,278

)

Goodwill, net

 

$

4,878

 

 

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

 

 

 

 

 

 

 

June 30, 2017

 

 

 

Average Amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

$

1,713

 

 

$

(1,704

)

 

$

9

 

Customer relationships

 

 

9.5

 

 

 

4,940

 

 

 

(1,108

)

 

 

3,832

 

Trade names - finite life

 

 

12

 

 

 

800

 

 

 

(89

)

 

 

711

 

Regulatory approvals

 

 

1.17

 

 

 

670

 

 

 

(383

)

 

 

287

 

Non-compete agreement

 

 

2.0

 

 

 

80

 

 

 

(37

)

 

 

43

 

Total definite-lived intangible assets

 

 

 

 

 

$

8,203

 

 

$

(3,321

)

 

$

4,882

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 

 

 

 

 

 

 

 

December 31, 2016

 

 

 

Average Amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

$

1,713

 

 

$

(1,696

)

 

$

17

 

Customer relationships

 

 

9.5

 

 

 

4,940

 

 

 

(602

)

 

 

4,338

 

Trade names - finite life

 

 

12

 

 

 

800

 

 

 

(56

)

 

 

744

 

Regulatory approvals

 

 

1.17

 

 

 

670

 

 

 

(96

)

 

 

574

 

Non-compete agreement

 

 

2.0

 

 

 

80

 

 

 

(17

)

 

 

63

 

Total definite-lived intangible assets

 

 

 

 

 

$

8,203

 

 

$

(2,467

)

 

$

5,736

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 

 

Amortization expense for the three months ended June 30, 2017 and 2016 was $0.4 million and $0.2 million, respectively. Amortization expense for the six months ended June 30, 2017 and 2016 was $0.9 and $0.3 respectively. The following table summarizes the estimated amortization expense relating to the Company's intangible assets as of June 30, 2017 (in thousands):

 

 

 

Amortization

 

Period

 

Expense

 

Remainder of 2017

 

$

854

 

2018

 

 

1,090

 

2019

 

 

794

 

2020

 

 

582

 

2021

 

 

435

 

Thereafter

 

 

1,127

 

 

 

$

4,882

 

 

 

d.

Accrued and Other Current Liabilities

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

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Accrued clinical trial and research and development expenses

 

$

119

 

 

$

119

 

Audit, consulting and legal fees

 

 

3,373

 

 

 

803

 

Payroll and related expenses

 

 

3,177

 

 

 

2,592

 

Accrued commission

 

 

1,774

 

 

 

1,222

 

Warrant liability

 

 

182

 

 

 

99

 

Other

 

 

1,729

 

 

 

1,672

 

 

 

$

10,354

 

 

$

6,507

 

 

Long-Term Debt and Revolving Line of Credit
Long-Term Debt and Revolving Line of Credit

9.

Long-Term Debt and Revolving Line of Credit

 

In March 2017, the Company entered into a Loan and Security Agreement, or the Loan Agreement, with Silicon Valley Bank, or SVB. Under the terms of the Loan Agreement, SVB made available to the Company a revolving line of credit of up to $15.0 million, or the Revolving Line, and a $5.0 million term loan, or the Term Loan. As of June 30, 2017, the Company had not borrowed any amounts under the Term Loan. In April 2017, the Company borrowed $5.0 million under the Revolving Line. The Company intends to use the proceeds from the Loan Agreement for working capital and other general corporate purposes.

 

Any indebtedness under the Term Loan and the Revolving Line bear interest at a floating per annum rate equal to the prime rate as reported in The Wall Street Journal, which as of the closing date was 3.75%, plus 1.00%. The Term Loan has a scheduled maturity date of March 1, 2020. The Company must make monthly payments of accrued interest under the Term Loan from the funding date of the Term Loan, or the Funding Date, until April 1, 2018, followed by monthly installments of principal and interest through the Term Loan maturity date. The interest-only period may be extended until April 1, 2019 if the Company has obtained FDA certification of the manufacturing facility operated by Vesta by March 31, 2018. The Company may prepay all, but not less than all, of the Term Loan prior to its maturity date provided the Company pays SVB a prepayment charge based on a percentage of the then-outstanding principal balance which shall be equal to 2% if the prepayment occurs prior to the second anniversary of the Funding Date, and 1% if the prepayment occurs thereafter. Upon making the final payment of the Term Loan, whether upon prepayment, acceleration or at maturity, the Company is required to pay a 12.5% fee on the original principal amount of the Term Loan.

The amount of loans available to be drawn under the Revolving Line is based on a borrowing base equal to 80% of the Company’s eligible accounts; provided that if the Company maintains an adjusted quick ratio (as defined in the Loan Agreement) of 1.5:1.0 for three continuous consecutive months, they may access the full Revolving Line. The Company may make (subject to the applicable borrowing base at the time) and repay borrowings from time to time under the Revolving Line until the maturity of the facility on March 13, 2022.  

 

The Loan Agreement includes customary affirmative and restrictive covenants and representations and warranties, including a financial covenant to maintain the adjusted quick ratio (as defined in the Loan Agreement) of 1.15:1.0 while borrowings are outstanding and until the Company has obtained FDA certification of the manufacturing facility operated by Vesta, a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, mergers or acquisitions, taxes, corporate changes, and deposit accounts. The Loan Agreement also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of any “material adverse change” as set forth in the Loan Agreement, penalties or judgements in an amount of at least $1.0 million rendered against the Company by any governmental agency and certain events relating to bankruptcy or insolvency. 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 SVB may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Loan Agreement. The Company’s obligations under the Loan Agreement are secured by a security interest in substantially all of The Company’s assets, other than intellectual property.

 

In connection with the entry into the Term Loan, the Company will issue a warrant to SVB, or the Warrant, exercisable for such number of shares of the Company’s common stock as equal to $87,500 divided by a price per share equal to the average closing price of the Company’s common stock on the NASDAQ Capital Market for the five trading days prior to the Funding Date. The Warrant may be exercised on a cashless basis, and is immediately exercisable from the Funding Date through the earlier of (i) the five year anniversary of the Funding Date, or (ii) the consummation of certain acquisition transactions involving the Company as set forth in the Warrant.

 

At the closing of the Loan Agreement, SVB earned a commitment fee of $937,500 of which $187,500 was payable on the closing date and the remainder of which is due and payable by the Company in increments of $187,500 on each anniversary thereof.

 

On July 27, 2017, 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 as well as the obligation to issue a warrant to SVB (see Note 13 – Subsequent Events – Credit Agreements with MidCap Financial Trust). 

Stockholders' Equity
Stockholders' Equity

10.

Stockholders’ Equity

 

a.

Authorized Stock

The Company’s Amended and Restated Certificate of Incorporation authorizes the Company to issue 210,000,000 shares of common and preferred stock, consisting of 200,000,000 shares of common stock with $0.01 par value and 10,000,000 shares of preferred stock with $0.01 par value. As of June 30, 2017 and December 31, 2016, the Company had no preferred stock issued or outstanding.

 

b.

Common Stock Warrants

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 June 30, 2017, there were warrants to purchase an aggregate of 47,710 shares of common stock outstanding.

 

c.

Stock Option Plans

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 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 June 30, 2017, a total of 462,417 shares of the Company’s common stock were reserved 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 June 30, 2017, inducement grants for 330,000 shares of common stock have been awarded, and 34,000 shares of common stock were reserved 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 be not less than 100% of the estimated fair value of the shares on the date of grant.  Options generally vest with 25% of the grant vesting on the first anniversary and the balance vesting monthly on a straight-lined basis over the requisite service period of three additional years for the award. 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 average

 

 

 

 

 

 

 

Weighted

 

 

remaining

 

 

 

 

 

 

 

average

 

 

contractual

 

 

 

Option Shares

 

 

exercise price

 

 

term (year)

 

Balances at December 31, 2016

 

 

2,786,977

 

 

$

7.27

 

 

 

6.28

 

Granted

 

 

90,000

 

 

 

8.50

 

 

 

 

 

Exercised

 

 

(417,172

)

 

 

2.63

 

 

 

 

 

Forfeited

 

 

(253,921

)

 

 

12.25

 

 

 

 

 

Balances at June 30, 2017

 

 

2,205,884

 

 

$

7.63

 

 

 

7.59

 

 

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 was $0.5 million and $0.5 million for the three months ended June 30, 2017 and 2016, respectively. Stock-based compensation expense was $1.2 million and $0.8 million for the six months ended June 30, 2017 and 2016, respectively. As of June 30, 2017, there was $3.6 million of unrecognized compensation costs related to stock options. The expense is recorded within the operating expense components in the statement of operations based on the recipients receiving the awards. These costs are expected to be recognized over a weighted average period of 2.33 years.

 

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 generally vest on a straight-line basis, either quarterly over a 4-year requisite service period or annually over a 3-year requisite service period.

Activity related to RSUs is set forth below:

 

 

 

 

 

 

 

Weighted average

 

 

 

 

 

 

 

grant date

 

 

 

Number of shares

 

 

fair value

 

Balances at December 31, 2016

 

 

430,733

 

 

$

7.99

 

Granted

 

 

700,246

 

 

 

8.43

 

Vested

 

 

(251,160

)

 

 

7.76

 

Restricted stock units withheld for tax

 

 

68,968

 

 

 

8.28

 

Forfeited

 

 

(22,000

)

 

 

8.49

 

Balances at June 30, 2017

 

 

926,787

 

 

$

8.40

 

 

Stock-based compensation expense for RSUs for the three months ended June 30, 2017 and 2016 was $1.2 million and $0.4 million, respectively. Stock-based compensation expense for RSUs for the six months ended June 30, 2017 and 2016 was $1.8 million and $0.6 million, respectively. As of June 30, 2017, there was $6.2 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 2.00 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 exercise date.  A total of 255,500 shares of common stock were initially reserved for issuance under the ESPP, subject to certain annual increases.  

As of June 30, 2017, the number of shares of common stock reserved for issuance under the ESPP was 770,549.  During the six months ended June 30, 2017, employees purchased 54,559 shares of common stock at a weighted average price of $5.93 per share.  As of June 30, 2017, the number of shares of common stock available for future issuance was 549,073.

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 $0.1 million for the three months ended June 30, 2017 and 2016, respectively. Stock-based compensation expense related to the ESPP was $0.2 million and $0.2 million for the six months ended June 30, 2017 and 2016, respectively.

Income Taxes
Income Taxes

11.

Income Taxes

The Company operates in several tax jurisdictions and is subject to taxes in each jurisdiction in which it conducts business. To date, the Company has incurred cumulative net losses and maintains a full valuation allowance on its net deferred tax assets due to the uncertainty surrounding realization of such assets. However, the Company has deferred tax liabilities associated with indefinite-lived intangible assets that cannot be considered sources of income to support the realization of the deferred tax assets, and has provided for tax expense and a corresponding deferred tax liability associated with these indefinite-lived intangible assets. Tax expense was $0.0 million and  $0.1 million for the three and six months ended June 30, 2017. There was no tax expense for the three and six months ended June 30, 2016.

Commitments and Contingencies
Commitments and Contingencies

12.

Commitments and Contingencies

 

a.

Operating Leases

The Company’s lease for its general office facility in Santa Barbara, California expires in February 2020. The Company also leases additional industrial space for warehouse, research and development and additional general office use.  Rent expense was $0.1 million and $0.1 million for the three months ended June 30, 2017 and 2016, respectively. Rent expense was $0.3 million and $0.3 million for the six months ended June 30, 2017 and 2016. The Company recognizes rent expense on a straight-line basis over the lease term.

 

b.

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.

Class Action Shareholder Litigation

On September 25, 2015, a lawsuit styled as a class action of the Company’s stockholders was filed in the United States District Court for the Central District of California. The lawsuit names the Company and certain of its officers as defendants, or the Sientra Defendants, and alleges violations of Sections 10(b) and 20(a) of the Exchange Act in connection with allegedly false and misleading statements concerning the Company’s business, operations, and prospects.  The plaintiff seeks damages and an award of reasonable costs and expenses, including attorneys’ fees. On November 24, 2015, three stockholders (or groups of stockholders) filed motions to appoint lead plaintiff(s) and to approve their selection on lead counsel.  On December 10, 2015, the court entered an order appointing lead plaintiffs and approving their selection of lead counsel.  On February 19, 2016, lead plaintiffs filed their consolidated amended complaint, which added claims under Sections 11, 12(a)(2) and 15 of the Securities Act and named as defendants the underwriters associated with the Company’s follow-on public offering that closed on September 23, 2015, or the Underwriter Defendants. On March 21, 2016, the Sientra Defendants and the Underwriter Defendants each filed a motion to dismiss, or the Motions to Dismiss, the consolidated amended complaints. On April 20, 2016, lead plaintiffs filed their opposition to the Motions to Dismiss, and the Sientra Defendants and Underwriter Defendants filed separate replies on May 5, 2016. On June 9, 2016, the court granted in part and denied in part the Motions to Dismiss.  On July 14, 2016, the Sientra Defendants moved the court to reconsider its June 9, 2016 order and grant the Motions to Dismiss in full. On August 4, 2016, lead plaintiffs filed an opposition to the motion for reconsideration. On August 12, 2016, the court denied the motion for reconsideration, and the Sientra Defendants and the Underwriter Defendants each filed an answer to the consolidated amended complaint.

On October 28, November 5, and November 19, 2015, three lawsuits styled as class actions of the Company’s stockholders were filed in the Superior Court of California for the County of San Mateo. The lawsuits name the Company, certain of its officers and directors, and the underwriters associated with the Company’s follow-on public offering that closed on September 23, 2015 as defendants. The lawsuits allege violations of Sections 11, 12(a)(2), and 15 of the Securities Act in connection with allegedly false and misleading statements in the Company’s offering documents associated with the follow-on offering concerning its business, operations, and prospects. The plaintiffs seek damages and an award of reasonable costs and expenses, including attorneys’ fees. On December 4, 2015, defendants removed all three lawsuits to the United States District Court for the Northern District of California.  On December 15 and December 16, 2015, plaintiffs filed motions to remand the lawsuits back to San Mateo Superior Court, or the Motions to Remand.  On January 19, 2016, defendants filed their opposition to the Motions to Remand, and plaintiffs filed their reply in support of the Motions to Remand on January 26, 2016. 

On May 20, 2016, the United States District Court for the Northern District of California granted plaintiffs’ Motions to Remand, and the San Mateo Superior Court received the remanded cases on May 27, 2016.  On July 19, 2016, the San Mateo Superior Court consolidated the three lawsuits.  On August 2, 2016, plaintiffs filed their consolidated complaint. On August 5, 2016, defendants filed a motion to stay all proceedings in favor of the class action filed in the United States District Court for the Central District of California.

On September 13, 2016, the parties to the actions pending in the San Mateo Superior Court and the United States District Court for the Central District of California signed a memorandum of understanding that sets forth the material deal points of a settlement that covers both actions and includes class-wide relief. On September 13, 2016 and September 20, 2016, respectively, the parties filed notices of settlement in both courts. On September 22, 2016, the United States District Court for the Central District of California stayed that action pending the court’s approval of a settlement. On September 23, 2016, the San Mateo Superior Court stayed that action as well pending the court’s approval of a settlement.

On December 20, 2016, the plaintiffs in the federal court action filed a motion for preliminary approval of the class action settlement.  On January 23, 2017, the United States District Court for the Central District of California preliminarily approved the settlement. A final approval hearing in that court is scheduled for May 22, 2017.  On January 5, 2017, the plaintiffs in the state court action also filed a motion for preliminary approval of the class action settlement.  On February 7, 2017, the San Mateo Superior Court preliminarily approved the settlement. On April 24, 2017, the plaintiffs in the federal court action and the state court action each filed their motion for final approval of the class action settlement, approval of the proposed plan of allocation, and an award of attorneys’ fees and expenses. Following a final fairness hearing in the federal court, on May 23, 2017, the federal court extended an order granting final approval of the settlement and dismissing the federal court action with prejudice. Following a final fairness hearing in the state court, on May 31, 2017, the state court entered an order granting final approval of the settlement and dismissing the state court action with prejudice.

As a result of these developments, the Company determined a probable loss had been incurred and recognized a net charge to earnings of approximately $1.6 million for the year ended December 31, 2016 within general and administrative expense which was comprised of the loss contingency of approximately $10.9 million, net of expected insurance proceeds of approximately $9.4 million. In the first quarter of 2017, the Company received $9.3 million in insurance proceeds and paid the $10.9 million loss contingency. The remaining insurance proceeds receivable is classified as “insurance recovery receivable” on the accompanying condensed balance sheets.

Silimed Litigation

On November 6, 2016, Silimed filed a lawsuit in the United States District Court for the Southern District of New York, the Silimed Litigation, naming Sientra as the defendant and alleging breach of contract of the Silimed Agreement, unfair competition and misappropriation of trade secrets against us.  In its complaint, Silimed alleges that the Company’s theft, misuse, and improper disclosure of Silimed’s confidential, proprietary, and trade secret manufacturing information was done in order for the Company to develop its own manufacturing capability that it intends to use to manufacture our PMA-approved products.  Silimed is seeking a declaration that the Company is in material breach of the Silimed Agreement, a preliminary and permanent injunction to prevent the Company’s allegedly wrongful use and disclosure of Silimed’s confidential and proprietary information, as well as unquantified compensatory and punitive damages.  On November 15, 2016, Sientra filed its answer and counterclaims for declaratory judgment in which it denied that Silimed is entitled to any relief including, among other reasons, because of Silimed’s material breach of the Silimed Agreement and Silimed’s unclean hands, and further seeks declaratory relief that Sientra is the owner of certain assets it acquired from Silimed, Inc. in 2007, that Sientra owns, or is exclusively licensed, to any improvements created since April 2007, that Silimed lacks any confidential information or proprietary rights under the Silimed Agreement, and that Silimed lacks any relevant trade secret rights.  On December 9, 2016, Silimed filed a motion to strike the Company’s counterclaims.  Briefing on that motion was completed on December 30, 2016, and the parties are waiting for a decision from the court.  On February 1, 2017, Sientra filed a motion to stay Silimed’s breach of contract claim in light of a demand for arbitration filed by Sientra against Silimed on January 20, 2017 concerning Silimed’s material breaches of the Silimed Agreement, and to further dismiss, or alternatively stay, the unfair competition and misappropriation of trade secrets claims.  Briefing on that motion was completed on February 22, 2017, and the parties are waiting for a decision from the court.  On February 3, 2017, the court held an initial pre-trial conference and entered a pre-trial scheduling order which set a final pre-trial conference date of August 3, 2018. 

 

On January 20, 2017, Sientra filed an arbitration demand in the International Center for Dispute Resolution, or ICDR, in New York, the Silimed Arbitration, naming Silimed as the defendant and alleging material breach of the Silimed Agreement, gross negligence and tortious interference by Silimed, as well as seeking certain declaratory relief.  Among other things, Sientra alleges that Silimed’s supply failure constitutes a material breach of the Silimed Agreement, and that such breach was caused by Silimed’s grossly negligent or other willful conduct related to its regulatory suspensions and the fire at its manufacturing facility.   Silimed filed its answer to Sientra’s arbitration demand and counterclaim on March 8, 2017.  Sientra filed its answer to Silimed’s counterclaims on April 10, 2017.  The parties nominated their party arbitrators on March 13, 2017 and their appointment was confirmed by the ICDR by April 5. 2017.  The party appointed arbitrators nominated a president of the tribunal on May 8, 2017 whose appointment was confirmed by the ICDR.  On May 30, 2017 a Preparatory Conference was held with the arbitration tribunal on June 26, 2017. A court-ordered settlement conference was held between the parties on June 27, 2017.

 

The lawsuit between Sientra and Silimed was settled pursuant to a settlement agreement, or the Settlement Agreement, dated July 27, 2017. Pursuant to the Settlement Agreement, in exchange for a mutual release of claims and covenants not to sue or pursue certain litigation, Sientra will pay Silimed a lump sum of $9.0 million within 30-days of execution of the Settlement Agreement, and $1.0 million on or by July 1, 2018.  In addition, should the Company enter into international markets using certain breast implant specifications, the Company has agreed to make royalty payments of $12.50 on each of its net sales of such products, up to a maximum royalty of $5.0 million. (see Note 13 -- Subsequent Events--Silimed Litigation)

It is possible that additional suits will be filed, or allegations made by stockholders, with respect to these same or other matters and also naming the Company and/or its officers and directors as defendants. The Company believes it has meritorious defenses and intends to defend these lawsuits vigorously. 

Subsequent Events
Subsequent Events

13.Subsequent Events

 

a.

Acquisition of Miramar Labs

On June 11, 2017, Sientra entered into an Agreement and Plan of Merger, or the Merger Agreement, with Miramar Labs, Inc., or Miramar, pursuant to which Sientra commenced a tender offer to purchase all of the outstanding shares of Miramar’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 $20 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, the only FDA cleared device to reduce underarm sweat, odor and permanently reduce hair of all colors to Sientra’s aesthetics portfolio.

 

b.

Credit Agreements with Midcap Financial Trust

On July 25, 2017, Sientra borrowed $25.0 million aggregate principal amount of term loans, or the Closing Term Loans, pursuant to a Credit and Security Agreement (Term Loan), or the Term Loan Credit Agreement, with MidCap Financial Trust, or Midcap, and the other lenders party thereto. Sientra used the proceeds of the Closing Term Loans (i) to repay in full Sientra’s existing indebtedness under its Loan Agreement with SVB, which totaled approximately $5.0 million, (ii) to pay fees and expenses in connection with the foregoing and (iii) for general corporate purposes. The Credit Agreement provides for (i) the Closing Date Term Loans, (ii) until March 31, 2018, an additional $10.0 million term loan facility subject to the satisfaction of certain conditions, including FDA certification of the manufacturing facility operated by Vesta and (iii) an additional $5.0 million term loan facility subject to the satisfaction of certain conditions, including evidence that Sientra’s Net Revenue (as defined in the Term Loan Credit Agreement) for the past 12 months was greater than or equal to $75.0 million, or collectively, the Term Loans.

On July 25, 2017, Sientra also entered in to a Credit and Security Agreement (Revolving Loan), or the Revolving Credit Agreement and, together with the Term Loan Credit Agreement, the Credit Agreements, with MidCap and the other lenders party thereto. The amount of loans available to be drawn under the Revolving Credit Agreement is based on a borrowing base equal to 85% of eligible accounts, subject to certain adjustments.  Sientra may make (subject to the applicable borrowing base at the time) and repay borrowings from time to time under the Revolving Credit Agreement until the maturity of the facility on December 1, 2021.

The obligations under each Credit Agreement are guaranteed by Sientra and each of Sientra’s existing and subsequently acquired or formed direct and indirect subsidiaries. The obligations under the Credit Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in (i) all tangible and intangible assets of Sientra and the guarantors, except for certain customary excluded property, and (ii) all of the capital stock owned by Sientra and guarantors thereunder.

The interest rate applicable to the Term Loans is LIBOR plus 7.50%, and the interest rate applicable to loans incurred under the Revolving Credit Agreement is LIBOR plus 4.50%, in both cases subject to a LIBOR floor of 1.0%.

Each Credit Agreement requires that the Borrowers (i) maintain Net Revenue (as defined in each Credit Agreement) in amounts set forth in each Credit Agreement and (ii) at all times, maintain cash and cash equivalents of at least $10.0 million.  The Credit Agreements also contain customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions.

 

c.

Silimed Settlement

 

On June 27, 2017, Silimed and Sientra participated in a court-ordered settlement conference pursuant to which they reached a definitive settlement of the Silimed Litigation and Silimed Arbitration subject to execution of a formal settlement agreement (the “Settlement Agreement”).  The parties executed the Settlement Agreement on July 27, 2017.  Pursuant to the Settlement Agreement. Sientra and Silimed have granted mutual releases to each other with respect to certain specified conduct, and have granted each other covenants not to sue with respect to certain specified conduct.  The Company has also agreed to pay Silimed a lump sum of $9.0 million within 30-days of execution of the Settlement Agreement, and $1.0 million on or by July 1, 2018.  In addition, should the Company enter into international markets using certain breast implant specifications, the Company has agreed to make royalty payments of $12.50 on each of its net sales of such products, up to a maximum royalty of $5.0 million. The Settlement Agreement was a compromise and settlement of disputed claims between the parties and not an admission of liability which was expressly denied.

 

Summary of Significant Accounting Policies (Policies)

 

a.

Basis of Presentation

The accompanying unaudited condensed 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 financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 14, 2017, or the Annual Report. The results for the three and six months ended June 30, 2017 are not necessarily indicative of results to be expected for the year ending December 31, 2017, any other interim periods, or any future year or period.

 

b.

Going Concern  

The accompanying 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. The Company’s manufacturing contract with Silimed, expired on its terms on April 1, 2017, and the Company did not renew that contract.  Accordingly, the Company continues to evaluate the availability of alternative manufacturing sources, including with Vesta Intermediate Funding, Inc., or Vesta, a Lubrizol Lifesciences company, which is establishing manufacturing capacity for the Company and with which the Company executed a definitive manufacturing agreement for the long-term supply of the Company’s PMA-approved breast implants. The continuation of the Company as a going concern is dependent upon many factors including resolution of any outstanding disputes with Silimed (see Note 12—Commitments and Contingencies), the availability of alternative manufacturing sources, and continued sale of the Company’s products. Since inception, the Company has incurred net losses. As of June 30, 2017, the Company had cash and cash equivalents of $55.5 million. Furthermore, through the Loan and Security Agreement, Silicon Valley bank made available to the Company a revolving line of credit of up to $15.0 million, or the Revolving Line, and a $5.0 million term loan, or the Term Loan. The Company believes that it has the ability to continue as a going concern for at least 12 months from the date the Company’s financial statements are issued. These financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

On July 25, 2017, the Company acquired Miramar Labs, Inc. and also entered into certain credit agreements with Midcap Financial Trust (see Subsequent Events – Acquisition of Miramar Labs and Credit Agreements with MidCap Financial Trust for more information).

 

c.

Use of Estimates

The preparation of the condensed 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 financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

 

d.

Significant Accounting Policies

There have been no significant changes to the accounting policies during the three and six months ended June 30, 2017, as compared to the significant accounting policies described in the “Notes to Financial Statements” in the Annual Report.

 

e.

Recent Accounting Pronouncements

Recently Adopted Accounting Standards

In July 2015, the FASB issued accounting standard update, or ASU, 2015-11, Inventory - Simplifying the Measurement of Inventory.  The standard simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. The accounting standards update will not apply to inventories that are measured by using either the last-in, first-out method or the retail inventory method. The Company adopted ASU 2015-11 in the first quarter of 2017 on a prospective basis. The adoption of this ASU did not have a material impact on the Company’s financial statements.

 

In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718). The standard identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. The Company adopted ASU 2016-09 in the first quarter of 2017 on a prospective basis. The Company has made an accounting policy election to account for forfeitures when they occur. The adoption of this ASU did not have a material impact on the Company’s financial statements.

 

In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350) - Simplifying the Test for Goodwill Impairment. The standard update eliminates Step 2 from the goodwill impairment test. The guidance requires an entity to perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value. In addition, the guidance eliminates the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment. The standard will be effective for the Company beginning in fiscal year 2020. Early adoption is permitted for interim and annual goodwill impairment tests performed after January 1, 2017. The Company adopted ASU 2017-04 in the first quarter of 2017 on a prospective basis. The adoption of this ASU did not have a material impact on the Company’s financial statements. The Company will reassess any impact at year end

Recently Issued Accounting Standards

 

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers.  The standard was issued to provide a single framework that replaces existing industry and transaction specific GAAP with a five step analysis of transactions to determine when and how revenue is recognized. The accounting standard update will replace most existing revenue recognition guidance in GAAP when it becomes effective. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, to defer the effective date of ASU 2014-09 by one year.  Therefore, ASU 2014-09 will become effective for the Company beginning in fiscal year 2018. Early adoption would be permitted for the Company beginning in fiscal year 2017. The standard permits the use of either the retrospective or cumulative transition method.  In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. ASU 2016-20 is intended to clarify and suggest improvements to the application of current standards under Topic 606 and other Topics amended by ASU 2014-09, Revenue from Contracts with Customers (Topic 606). The effective date of ASU 2016-20 is the same as the effective date for ASU 2014-09. In preparation for our adoption of the new standard in our fiscal year ending December 31, 2018, we are reviewing contracts and other forms of agreements with our customers and are evaluating the provisions contained therein in light of the five-step model specified by the new guidance. That five-step model includes: (1) determination of whether a contract—an agreement between two or more parties that creates legally enforceable rights and obligations—exists; (2) identification of the performance obligations in the contract; (3) determination of the transaction price; (4) allocation of the transaction price to the performance obligations in the contract; and (5) recognition of revenue when (or as) the performance obligation is satisfied. We are also evaluating the impact of the new standard on certain common practices currently employed by us and by other medical device companies, such as allowance for sales returns, rebates, warranty and other pricing programs. We have not yet determined the impact of the new standard on our financial statements or whether we will adopt on a prospective or retrospective basis in the first quarter of our fiscal year ending December 31, 2018.

 

In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805) - Clarifying the Definition of a Business. The standard adds guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses by providing a more specific definition of a business. The updated accounting standard will be effective for the Company beginning in fiscal year 2018. The Company will evaluate the impact of this ASU on future acquisitions.

 

In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting. The standard provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award to which an entity would be required to apply modification accounting under ASC 718. The ASU is effective for the Company beginning in fiscal year 2018. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements and related disclosures.

 

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815). The standard is broken in to two parts. Part I addresses the complexity of accounting for certain financial instruments with down round features. Part II addresses the difficulty of navigating Topic 480 because of the existence of extensive pending content in the FASB Accounting Standards Codification. The ASU is effective for the Company beginning in fiscal year 2019. We have not yet determined the impact of the new standard on our financial statements.

Acquisitions (Tables)

The aggregate acquisition date fair value of the consideration transferred was estimated at $7.4 million, which consisted of the following (in thousands):

 

 

 

Fair Value

 

Cash

 

$

6,859

 

Deferred consideration

 

 

434

 

Contingent consideration

 

 

116

 

 

 

$

7,409

 

 

The following table summarizes the allocation of the fair value of the consideration transferred by major class for the business combination completed on March 9, 2016 (in thousands):

 

 

 

March 9,

 

 

 

2016

 

Inventory

 

$

100

 

Prepaid expenses

 

 

36

 

Goodwill

 

 

3,273

 

Intangible assets

 

 

4,000

 

 

 

$

7,409

 

 

A summary of the intangible assets acquired, estimated useful lives and amortization method is as follows (in thousands):

 

 

 

 

 

 

 

Estimated useful

 

 

Amortization

 

 

Amount

 

 

life (in years)

 

 

method

Customer relationships

 

$

3,200

 

 

 

10

 

 

Accelerated

Trade name

 

 

800

 

 

 

12

 

 

Straight-line

 

 

$

4,000

 

 

 

 

 

 

 

 

The aggregate preliminary acquisition date fair value of the consideration transferred was estimated at $6.0 million, which consisted of the following (in thousands):

 

 

 

Fair Value

 

Cash

 

$

4,950

 

Contingent consideration

 

 

1,050

 

 

 

$

6,000

 

 

The following table summarizes the allocation of the fair value of the consideration transferred by major class for the business combination completed on November 2, 2016 (in thousands):

 

 

 

November 2,

 

 

 

2016

 

Accounts receivable, net

 

$

196

 

Inventory

 

 

1,555

 

Equipment

 

 

34

 

Goodwill

 

 

1,605

 

Intangible assets

 

 

2,860

 

Liabilities assumed

 

 

(250

)

 

 

$

6,000

 

 

A summary of the intangible assets acquired, estimated useful lives and amortization method is as follows (in thousands):

 

 

 

 

 

 

 

Estimated useful

 

Amortization

 

 

Amount

 

 

life

 

method

Customer relationships

 

$

1,740

 

 

9 years

 

Accelerated

Regulatory approvals

 

 

670

 

 

14 months

 

Straight-line

Trade names

 

 

450

 

 

indefinite-lived

 

 

 

 

$

2,860

 

 

 

 

 

 

Fair Value Measurements (Tables)

The following tables present information about the Company’s liabilities that are measured at fair value on a recurring basis as of June 30, 2017 and December 31, 2016 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):

 

 

 

Fair Value Measurements as of

 

 

 

June 30, 2017 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liability for common stock warrants

 

$

 

 

 

 

 

 

182

 

 

 

182

 

Liability for deferred consideration

 

 

 

 

 

 

 

 

381

 

 

 

381

 

Liability for contingent consideration

 

 

 

 

 

 

 

 

1,705

 

 

 

1,705

 

 

 

$

 

 

 

 

 

 

2,268

 

 

 

2,268

 

 

 

 

Fair Value Measurements as of

 

 

 

December 31, 2016 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liability for common stock warrants

 

$

 

 

 

 

 

 

99

 

 

 

99

 

Liability for deferred consideration

 

 

 

 

 

 

 

 

395

 

 

 

395

 

Liability for contingent consideration

 

 

 

 

 

 

 

 

1,242

 

 

 

1,242

 

 

 

$

 

 

 

 

 

 

1,736

 

 

 

1,736

 

 

The following table provides a rollforward of the aggregate fair values of the Company’s common stock warrants, deferred and contingent consideration for which fair value is determined by Level 3 inputs (in thousands):

 

Warrant Liability

 

 

 

 

Balance, December 31, 2016

 

$

99

 

Fair value of warrants to be issued upon borrowing under the Silicon Valley Bank term loan

   (Note 9)

 

 

88

 

Change in fair value through June 30, 2017

 

 

(5

)

Balance, June 30, 2017

 

$

182

 

Deferred Consideration Liability

 

 

 

 

Balance, December 31, 2016

 

$

395

 

Change in fair value of deferred consideration

 

 

(14

)

Balance, June 30, 2017

 

$

381

 

Contingent Consideration Liability

 

 

 

 

Balance, December 31, 2016

 

$

1,242

 

Change in fair value of contingent consideration

 

 

463

 

Balance, June 30, 2017

 

$

1,705

 

 

Product Warranties (Tables)
Schedule of rollforward of the accrued warranties

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

 

 

 

Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

Beginning balance as of January 1

 

$

1,378

 

 

$

1,332

 

Payments made during the period

 

 

 

 

 

(9

)

Changes in accrual related to warranties issued during the period

 

 

110

 

 

 

76

 

Changes in accrual related to pre-existing warranties

 

 

9

 

 

 

(2

)

Balance as of June 30

 

$

1,497

 

 

$

1,397

 

 

Net Loss Per Share (Tables)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Net loss (in thousands)

 

$

 

(20,391

)

 

$

 

(10,193

)

 

$

(31,812

)

 

$

(22,130

)

Weighted average common shares outstanding, basic

   and diluted

 

 

 

19,132,052

 

 

 

 

18,075,010

 

 

 

18,953,500

 

 

 

18,062,803

 

Net loss per share attributable to common stockholders

 

$

 

(1.07

)

 

$

 

(0.56

)

 

$

(1.68

)

 

$

(1.23

)

 

 

 

 

June 30,

 

 

 

2017

 

 

2016

 

Stock options to purchase common stock

 

 

1,663,890

 

 

 

2,190,866

 

Warrants for the purchase of common stock

 

 

47,710

 

 

 

47,710

 

 

 

 

1,711,600

 

 

 

2,238,576

 

 

Balance Sheet Components (Tables)

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

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Leasehold improvements

 

$

96

 

 

$

86

 

Laboratory equipment and toolings

 

 

3,273

 

 

 

2,264

 

Computer equipment

 

 

308

 

 

 

287

 

Software

 

 

719

 

 

 

669

 

Office equipment

 

 

130

 

 

 

129

 

Furniture and fixtures

 

 

757

 

 

 

743

 

 

 

 

5,283

 

 

 

4,178

 

Less accumulated depreciation

 

 

(1,495

)

 

 

(1,192

)

 

 

$

3,788

 

 

$

2,986

 

 

The changes in the carrying amount of goodwill during the six months ended June 30, 2017 were as follows (in thousands):

 

Balances as of December 31, 2016

 

 

 

 

Goodwill

 

$

19,156

 

Accumulated impairment losses

 

 

(14,278

)

Goodwill, net

 

$

4,878

 

Balances as of June 30, 2017

 

 

 

 

Goodwill

 

$

19,156

 

Accumulated impairment losses

 

 

(14,278

)

Goodwill, net

 

$

4,878

 

 

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

 

 

 

 

 

 

 

June 30, 2017

 

 

 

Average Amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

$

1,713

 

 

$

(1,704

)

 

$

9

 

Customer relationships

 

 

9.5

 

 

 

4,940

 

 

 

(1,108

)

 

 

3,832

 

Trade names - finite life

 

 

12

 

 

 

800

 

 

 

(89

)

 

 

711

 

Regulatory approvals

 

 

1.17

 

 

 

670

 

 

 

(383

)

 

 

287

 

Non-compete agreement

 

 

2.0

 

 

 

80

 

 

 

(37

)

 

 

43

 

Total definite-lived intangible assets

 

 

 

 

 

$

8,203

 

 

$

(3,321

)

 

$

4,882

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 

 

 

 

 

 

 

 

December 31, 2016

 

 

 

Average Amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Period

 

 

Gross Carrying

 

 

Accumulated

 

 

Intangible

 

 

 

(in years)

 

 

Amount

 

 

Amortization

 

 

Assets, net

 

Intangibles with definite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Acquired FDA non-gel product approval

 

 

11

 

 

$

1,713

 

 

$

(1,696

)

 

$

17

 

Customer relationships

 

 

9.5

 

 

 

4,940

 

 

 

(602

)

 

 

4,338

 

Trade names - finite life

 

 

12

 

 

 

800

 

 

 

(56

)

 

 

744

 

Regulatory approvals

 

 

1.17

 

 

 

670

 

 

 

(96

)

 

 

574

 

Non-compete agreement

 

 

2.0

 

 

 

80

 

 

 

(17

)

 

 

63

 

Total definite-lived intangible assets

 

 

 

 

 

$

8,203

 

 

$

(2,467

)

 

$

5,736

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangibles with indefinite lives

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade names - indefinite life

 

 

 

 

450

 

 

 

 

 

 

450

 

Total indefinite-lived intangible assets

 

 

 

 

 

$

450

 

 

$

 

 

$

450

 

 

The following table summarizes the estimated amortization expense relating to the Company's intangible assets as of June 30, 2017 (in thousands):

 

 

 

Amortization

 

Period

 

Expense

 

Remainder of 2017

 

$

854

 

2018

 

 

1,090

 

2019

 

 

794

 

2020

 

 

582

 

2021

 

 

435

 

Thereafter

 

 

1,127

 

 

 

$

4,882

 

 

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

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Accrued clinical trial and research and development expenses

 

$

119

 

 

$

119

 

Audit, consulting and legal fees

 

 

3,373

 

 

 

803

 

Payroll and related expenses

 

 

3,177

 

 

 

2,592

 

Accrued commission

 

 

1,774

 

 

 

1,222

 

Warrant liability

 

 

182

 

 

 

99

 

Other

 

 

1,729

 

 

 

1,672

 

 

 

$

10,354

 

 

$

6,507

 

 

Stockholders' Equity (Tables)

 

 

 

 

 

 

 

 

 

 

 

Weighted average

 

 

 

 

 

 

 

Weighted

 

 

remaining

 

 

 

 

 

 

 

average

 

 

contractual

 

 

 

Option Shares

 

 

exercise price

 

 

term (year)

 

Balances at December 31, 2016

 

 

2,786,977

 

 

$

7.27

 

 

 

6.28

 

Granted

 

 

90,000

 

 

 

8.50

 

 

 

 

 

Exercised

 

 

(417,172

)

 

 

2.63

 

 

 

 

 

Forfeited

 

 

(253,921

)

 

 

12.25

 

 

 

 

 

Balances at June 30, 2017

 

 

2,205,884

 

 

$

7.63

 

 

 

7.59

 

 

 

 

 

 

 

 

 

Weighted average

 

 

 

 

 

 

 

grant date

 

 

 

Number of shares

 

 

fair value

 

Balances at December 31, 2016

 

 

430,733

 

 

$

7.99

 

Granted

 

 

700,246

 

 

 

8.43

 

Vested

 

 

(251,160

)

 

 

7.76

 

Restricted stock units withheld for tax

 

 

68,968

 

 

 

8.28

 

Forfeited

 

 

(22,000

)

 

 

8.49

 

Balances at June 30, 2017

 

 

926,787

 

 

$

8.40

 

 

Formation and Business of the Company (Details)
0 Months Ended
Jul. 11, 2016
Organization Consolidation And Presentation Of Financial Statements [Abstract]
 
Term of the Silimed GMP certificate
2 years 
Summary of Significant Accounting Policies (Details) (USD $)
6 Months Ended
Jun. 30, 2017
Mar. 31, 2017
Dec. 31, 2016
Jun. 30, 2016
Dec. 31, 2015
Summary Of Significant Accounting Policies [Line Items]
 
 
 
 
 
Cash and cash equivalents
$ 55,495,000 
 
$ 67,212,000 
$ 86,159,000 
$ 112,801,000 
Going concern within next 12 months
false 
 
 
 
 
Revolving line of credit borrowing capacity
15,000,000 
15,000,000 
 
 
 
Term loan borrowing capacity
$ 5,000,000 
$ 5,000,000 
 
 
 
Miramar Labs, Inc.,
 
 
 
 
 
Summary Of Significant Accounting Policies [Line Items]
 
 
 
 
 
Effective date of acquisition
Jul. 25, 2017 
 
 
 
 
Acquisitions (Details) (USD $)
0 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended 0 Months Ended
Mar. 9, 2016
U.S. Rights to BIOCORNEUM
Jan. 1, 2024
U.S. Rights to BIOCORNEUM
Forecast
Jun. 30, 2017
U.S. Rights to BIOCORNEUM
Minimum
Jun. 30, 2017
U.S. Rights to BIOCORNEUM
General & administrative expense
Jun. 30, 2016
U.S. Rights to BIOCORNEUM
General & administrative expense
Jun. 30, 2017
U.S. Rights to BIOCORNEUM
General & administrative expense
Jun. 30, 2016
U.S. Rights to BIOCORNEUM
General & administrative expense
Nov. 2, 2016
Tissue Expander Portfolio from SSP
Jun. 30, 2017
Tissue Expander Portfolio from SSP
Jun. 30, 2016
Tissue Expander Portfolio from SSP
Jun. 30, 2017
Tissue Expander Portfolio from SSP
Jun. 30, 2016
Tissue Expander Portfolio from SSP
Jun. 30, 2017
Tissue Expander Portfolio from SSP
Maximum
Jun. 11, 2017
Miramar Labs, Inc.,
Jun. 30, 2017
Miramar Labs, Inc.,
Jun. 11, 2017
Miramar Labs, Inc.,
Maximum
Business Acquisition [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Professional fees
 
 
 
$ 0 
$ 0 
$ 0 
$ 200,000 
 
$ 0 
$ 0 
$ 0 
$ 0 
 
 
 
 
Cash
6,859,000 
 
 
 
 
 
 
4,950,000 
 
 
 
 
 
20,000,000 
 
 
Deferred consideration
434,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contingent consideration
116,000 
 
 
 
 
 
 
1,050,000 
 
 
 
 
 
 
 
14,000,000 
Total
7,409,000 
 
 
 
 
 
 
6,000,000 
 
 
 
 
 
 
 
 
Estimated future payments due
 
 
$ 500,000 
 
 
 
 
 
 
 
 
 
$ 2,000,000 
 
 
 
Number of years for future royalty payments to be paid
 
4 years 6 months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Effective date of acquisition
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jul. 25, 2017 
 
Acquisitions - Fair Value (Details) (USD $)
In Thousands, unless otherwise specified
0 Months Ended 0 Months Ended
Jun. 30, 2017
Dec. 31, 2016
Mar. 9, 2016
U.S. Rights to BIOCORNEUM
Mar. 9, 2016
U.S. Rights to BIOCORNEUM
Customer relationships
Mar. 9, 2016
U.S. Rights to BIOCORNEUM
Trade name
Nov. 2, 2016
Tissue Expander Portfolio from SSP
Nov. 2, 2016
Tissue Expander Portfolio from SSP
Trade name
Nov. 2, 2016
Tissue Expander Portfolio from SSP
Customer relationships
Nov. 2, 2016
Tissue Expander Portfolio from SSP
Regulatory approvals
Fair value of the assets acquired
 
 
 
 
 
 
 
 
 
Accounts receivable, net
 
 
 
 
 
$ 196 
 
 
 
Inventory
 
 
100 
 
 
1,555 
 
 
 
Prepaid expenses
 
 
36 
 
 
 
 
 
 
Equipment
 
 
 
 
 
34 
 
 
 
Goodwill
4,878 
4,878 
3,273 
 
 
1,605 
 
 
 
Intangible assets
 
 
4,000 
3,200 
800 
 
 
1,740 
670 
Intangible assets
 
 
 
 
 
2,860 
 
 
 
Liabilities assumed
 
 
 
 
 
(250)
 
 
 
Total fair value of assets acquired
 
 
7,409 
 
 
6,000 
 
 
 
Estimated useful life of asset
 
 
 
10 years 
12 years 
 
 
9 years 
14 months 
Amortization method
 
 
 
Accelerated 
Straight-line 
 
 
Accelerated 
Straight-line 
Intangible assets
 
 
 
 
 
 
$ 450 
 
 
Fair Value of Financial Instruments (Details) (Term loan agreement, USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Term loan agreement
 
Long-term Debt
 
Long-term Debt.
$ 0 
Fair Value Measurements (Details)
6 Months Ended
Jun. 30, 2017
Fair Value Disclosures [Abstract]
 
Estimated dividend yield
0.00% 
Fair Value Measurements - Schedule of Company's liabilities that are measured at fair value on a recurring basis (Details) (Recurring, USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Fair Value Measurements
 
 
Fair value liability
$ 2,268 
$ 1,736 
Warrants
 
 
Fair Value Measurements
 
 
Fair value liability
182 
99 
Deferred Consideration Liability
 
 
Fair Value Measurements
 
 
Fair value liability
381 
395 
Contingent Consideration Liability
 
 
Fair Value Measurements
 
 
Fair value liability
1,705 
1,242 
Level 3
 
 
Fair Value Measurements
 
 
Fair value liability
2,268 
1,736 
Level 3 |
Warrants
 
 
Fair Value Measurements
 
 
Fair value liability
182 
99 
Level 3 |
Deferred Consideration Liability
 
 
Fair Value Measurements
 
 
Fair value liability
381 
395 
Level 3 |
Contingent Consideration Liability
 
 
Fair Value Measurements
 
 
Fair value liability
$ 1,705 
$ 1,242 
Fair Value Measurements - Schedule of aggregate fair values of the Company's common stock warrants and contingent consideration for which fair value is determined by Level 3 inputs (Details) (Level 3, USD $)
In Thousands, unless otherwise specified
6 Months Ended
Jun. 30, 2017
Warrants
 
Fair values of the Company's liabilities determined by Level 3 inputs
 
Balance at beginning of the period
$ 99 
Fair value of warrants to be issued upon borrowing under the Silicon Valley Bank term loan (Note 9)
88 
Change in fair value
(5)
Balance at the end of the period
182 
Deferred Consideration Liability
 
Fair values of the Company's liabilities determined by Level 3 inputs
 
Balance at beginning of the period
395 
Change in fair value
(14)
Balance at the end of the period
381 
Contingent Consideration Liability
 
Fair values of the Company's liabilities determined by Level 3 inputs
 
Balance at beginning of the period
1,242 
Change in fair value
463 
Balance at the end of the period
$ 1,705 
Product Warranties (Details) (USD $)
In Thousands, unless otherwise specified
6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Product Warranties Disclosures [Abstract]
 
 
Period to claim reimbursement under limited warranty program
10 years 
 
Beginning balance
$ 1,378 
$ 1,332 
Payments made during the period
 
(9)
Changes in accrual related to warranties issued during the period
110 
76 
Changes in accrual related to pre-existing warranties
(2)
Ending Balance
$ 1,497 
$ 1,397 
Net Loss Per Share - Schedule of Net Loss Per Share, Basic and Diluted (Details) (USD $)
In Thousands, except Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Earnings Per Share [Abstract]
 
 
 
 
Net loss
$ (20,391)
$ (10,193)
$ (31,812)
$ (22,130)
Weighted average common shares outstanding, basic and diluted
19,132,052 
18,075,010 
18,953,500 
18,062,803 
Net loss per share attributable to common stockholders
$ (1.07)
$ (0.56)
$ (1.68)
$ (1.23)
Net Loss Per Share - Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details)
6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Potentially dilutive securities
 
 
Potentially dilutive securities
1,711,600 
2,238,576 
Stock options to purchase common stock
 
 
Potentially dilutive securities
 
 
Potentially dilutive securities
1,663,890 
2,190,866 
Warrants for the purchase of common stock
 
 
Potentially dilutive securities
 
 
Potentially dilutive securities
47,710 
47,710 
Balance Sheet Components (Allowance) (Details) (USD $)
In Millions, unless otherwise specified
6 Months Ended 12 Months Ended
Jun. 30, 2017
Dec. 31, 2016
Balance Sheet Related Disclosures [Abstract]
 
 
Allowance for sales returns
$ 4.1 
$ 3.9 
Allowance for doubtful accounts
$ 0.4 
$ 0.4 
Balance Sheet Components (PPE) (Details) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Dec. 31, 2016
Property and equipment, net
 
 
 
 
 
Property and equipment, gross
$ 5,283,000 
 
$ 5,283,000 
 
$ 4,178,000 
Less accumulated depreciation
(1,495,000)
 
(1,495,000)
 
(1,192,000)
Property and equipment, net
3,788,000 
 
3,788,000 
 
2,986,000 
Depreciation expense
200,000 
100,000 
300,000 
100,000 
 
Leasehold improvements
 
 
 
 
 
Property and equipment, net
 
 
 
 
 
Property and equipment, gross
96,000 
 
96,000 
 
86,000 
Laboratory equipment and toolings
 
 
 
 
 
Property and equipment, net
 
 
 
 
 
Property and equipment, gross
3,273,000 
 
3,273,000 
 
2,264,000 
Computer equipment
 
 
 
 
 
Property and equipment, net
 
 
 
 
 
Property and equipment, gross
308,000 
 
308,000 
 
287,000 
Software
 
 
 
 
 
Property and equipment, net
 
 
 
 
 
Property and equipment, gross
719,000 
 
719,000 
 
669,000 
Office equipment
 
 
 
 
 
Property and equipment, net
 
 
 
 
 
Property and equipment, gross
130,000 
 
130,000 
 
129,000 
Furniture and fixtures
 
 
 
 
 
Property and equipment, net
 
 
 
 
 
Property and equipment, gross
$ 757,000 
 
$ 757,000 
 
$ 743,000 
Balance Sheet Components (Goodwill and Intangibles) (Details) (USD $)
3 Months Ended 6 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Dec. 31, 2016
Jun. 30, 2017
Trade name
Dec. 31, 2016
Trade name
Jun. 30, 2017
Acquired FDA non-gel product approval
Dec. 31, 2016
Acquired FDA non-gel product approval
Jun. 30, 2017
Customer relationships
Dec. 31, 2016
Customer relationships
Jun. 30, 2017
Trade name
Dec. 31, 2016
Trade name
Jun. 30, 2017
Regulatory approvals
Dec. 31, 2016
Regulatory approvals
Jun. 30, 2017
Non-compete agreement
Dec. 31, 2016
Non-compete agreement
Goodwill and intangible assets
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Goodwill
$ 19,156,000 
 
$ 19,156,000 
 
$ 19,156,000 
 
 
 
 
 
 
 
 
 
 
 
 
Accumulated impairment losses
(14,278,000)
 
(14,278,000)
 
(14,278,000)
 
 
 
 
 
 
 
 
 
 
 
 
Goodwill, net
4,878,000 
 
4,878,000 
 
4,878,000 
 
 
 
 
 
 
 
 
 
 
 
 
Other intangible assets
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Average amortization period
 
 
 
 
 
 
 
11 years 
11 years 
9 years 6 months 
9 years 6 months 
12 years 
12 years 
1 year 2 months 1 day 
1 year 2 months 1 day 
2 years 
2 years 
Gross carrying amount
8,203,000 
 
8,203,000 
 
8,203,000 
 
 
1,713,000 
1,713,000 
4,940,000 
4,940,000 
800,000 
800,000 
670,000 
670,000 
80,000 
80,000 
Less accumulated amortization
(3,321,000)
 
(3,321,000)
 
(2,467,000)
 
 
(1,704,000)
(1,696,000)
(1,108,000)
(602,000)
(89,000)
(56,000)
(383,000)
(96,000)
(37,000)
(17,000)
Intangible assets, net
4,882,000 
 
4,882,000 
 
5,736,000 
 
 
9,000 
17,000 
3,832,000 
4,338,000 
711,000 
744,000 
287,000 
574,000 
43,000 
63,000 
Indefinite-lived intangible assets
450,000 
 
450,000 
 
450,000 
450,000 
450,000 
 
 
 
 
 
 
 
 
 
 
Amortization expense
400,000 
200,000 
900,000 
300,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
Estimated amortization expense
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Remainder of 2017
854,000 
 
854,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2018
1,090,000 
 
1,090,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2019
794,000 
 
794,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2020
582,000 
 
582,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2021
435,000 
 
435,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thereafter
1,127,000 
 
1,127,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total amortization
$ 4,882,000 
 
$ 4,882,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance Sheet Components (Accrued liabilities) (Details) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Accrued and other current liabilities
 
 
Accrued clinical trial and research and development expenses
$ 119 
$ 119 
Audit, consulting and legal fees
3,373 
803 
Payroll and related expenses
3,177 
2,592 
Accrued commission
1,774 
1,222 
Warrant liability
182 
99 
Other
1,729 
1,672 
Total
$ 10,354 
$ 6,507 
Long-Term Debt and Revolving Line of Credit (Details) (USD $)
1 Months Ended
Mar. 31, 2017
Jun. 30, 2017
Apr. 30, 2017
Line Of Credit Facility [Line Items]
 
 
 
Revolving line of credit borrowing capacity
$ 15,000,000 
$ 15,000,000 
 
Term loan borrowing capacity
5,000,000 
5,000,000 
 
Borrowed amounts under revolving line
 
 
5,000,000 
Term loan scheduled maturity date
Mar. 01, 2020 
 
 
Fee on principal amount of the term loan (as a percent)
12.50% 
 
 
Borrowing base of accounts receivable (as a percent)
80.00% 
 
 
Adjusted quick ratio
150.00% 
 
 
Penalties and judgements that will cause default
1,000,000 
 
 
Additional interest (as a percent)
5.00% 
 
 
Value of warrant
87,500 
 
 
Commitment fee
937,500 
 
 
Prime Rate
 
 
 
Line Of Credit Facility [Line Items]
 
 
 
Spread on variable rate basis (as a percent)
1.00% 
 
 
Interest rate (as a percent)
3.75% 
 
 
Interest rate basis
prime rate 
 
 
Prepayment Prior To The Second Anniversary
 
 
 
Line Of Credit Facility [Line Items]
 
 
 
Prepayment charge (as a percent)
2.00% 
 
 
Prepayment After The Second Anniversary
 
 
 
Line Of Credit Facility [Line Items]
 
 
 
Prepayment charge (as a percent)
1.00% 
 
 
Payable On Closing Date
 
 
 
Line Of Credit Facility [Line Items]
 
 
 
Commitment fee
187,500 
 
 
Payable On Anniversary Date
 
 
 
Line Of Credit Facility [Line Items]
 
 
 
Commitment fee
$ 187,500 
 
 
Stockholders' Equity (Details) (USD $)
Jun. 30, 2017
Dec. 31, 2016
Stock other disclosures
 
 
Common and preferred stock, shares authorized
210,000,000 
210,000,000 
Common stock, shares authorized
200,000,000 
200,000,000 
Common stock, par value (in dollars per share)
$ 0.01 
$ 0.01 
Preferred stock, shares authorized
10,000,000 
10,000,000 
Preferred stock, par value (in dollars per share)
$ 0.01 
$ 0.01 
Preferred stock, shares issued
Preferred stock, shares outstanding
Stockholders' Equity (Warrants) (Details) (USD $)
0 Months Ended 1 Months Ended
Jun. 30, 2017
Jun. 30, 2014
Oxford Finance, LLC
Jan. 17, 2013
Oxford Finance, LLC
Jan. 17, 2013
Tranche A, B and C loans
Oxford Finance, LLC
Jun. 30, 2014
Tranche D term loan
Oxford Finance, LLC
Common Stock Warrants
 
 
 
 
 
Warrant term
 
 
 
7 years 
7 years 
Percentage of term loan amounts
 
 
 
3.00% 
2.50% 
Exercise price (in dollars per share)
 
$ 14.671 
$ 14.671 
 
 
Aggregate number of common shares to purchase
47,710 
 
 
 
 
Stockholders' Equity (Options) (Details) (USD $)
In Millions, except Share data, unless otherwise specified
3 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2017
Stock options
Jun. 30, 2016
Stock options
Jun. 30, 2017
Stock options
Jun. 30, 2016
Stock options
Dec. 31, 2016
Stock options
Apr. 30, 2007
2007 Plan
Jun. 30, 2017
2014 Plan
Nov. 3, 2014
2014 Plan
Jun. 30, 2017
Inducement Plan
Jun. 30, 2017
Inducement Plan
On the first anniversary
Jun. 30, 2017
Inducement Plan
Minimum
Jun. 30, 2017
Inducement Plan
Minimum
Individual options
Jun. 30, 2017
Inducement Plan
Maximum
Jun. 30, 2017
2007 Plan and 2014 Plan
Stock options
Jun. 30, 2017
2007 Plan and 2014 Plan
Stock options
Minimum
Jun. 30, 2017
2007 Plan and 2014 Plan
Stock options
Maximum
Stockholders' Equity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Common stock reserved for issuance (in shares)
 
 
 
 
 
 
1,690,448 
462,417 
1,027,500 
 
 
 
 
 
 
 
 
Number of shares awarded
 
 
 
 
 
 
 
 
 
330,000 
 
 
 
 
 
 
 
Number of shares available for future grants
549,073 
 
 
 
 
 
 
 
 
34,000 
 
 
 
 
 
 
 
Grant period of stock awards
 
 
 
 
 
 
 
 
 
10 years 
 
 
 
 
10 years 
 
 
Purchase price of awards expressed as a percentage of fair value of shares on the date of grant
 
 
 
 
 
 
 
 
 
 
 
100.00% 
 
 
 
100.00% 
110.00% 
Percentage of voting power owned by shareholder
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.00% 
 
Vesting percentage
 
 
 
 
 
 
 
 
 
 
25.00% 
 
25.00% 
 
 
 
 
Number of additional years of requisite service period
 
 
 
 
 
 
 
 
 
3 years 
 
 
 
 
 
 
 
Percentage of possible payouts of the target award
 
 
 
 
 
 
 
 
 
 
 
0.00% 
 
100.00% 
 
 
 
Vesting period
 
 
 
 
 
 
 
 
 
1 year 
 
 
 
 
 
 
 
Number of options
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at the beginning of period (in shares)
 
 
 
2,786,977 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options granted (in shares)
 
 
 
90,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options exercised (in shares)
 
 
 
(417,172)
 
 
 
 
 
 
 
 
 
 
 
 
 
Options forfeited (in shares)
 
 
 
(253,921)
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at the end of the period (in shares)
 
2,205,884 
 
2,205,884 
 
2,786,977 
 
 
 
 
 
 
 
 
 
 
 
Weighted average exercise price
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at the beginning of period (in dollars per share)
 
 
 
$ 7.27 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options granted (in dollars per share)
 
 
 
$ 8.50 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options exercised (in dollars per share)
 
 
 
$ 2.63 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options forfeited (in dollars per share)
 
 
 
$ 12.25 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at the end of period (in dollars per share)
 
$ 7.63 
 
$ 7.63 
 
$ 7.27 
 
 
 
 
 
 
 
 
 
 
 
Additional information
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted average remaining contractual term
 
 
 
7 years 7 months 2 days 
 
6 years 3 months 11 days 
 
 
 
 
 
 
 
 
 
 
 
Stock-based compensation expense
 
$ 0.5 
$ 0.5 
$ 1.2 
$ 0.8 
 
 
 
 
 
 
 
 
 
 
 
 
Unrecognized compensation costs (in dollars)
 
$ 3.6 
 
$ 3.6 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted average period over which unrecognized compensation costs are expected to be recognized
 
 
 
2 years 3 months 29 days 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stockholders' Equity (Restricted Stock) (Details) (Restricted stock units, 2014 Plan and Inducement Plan, USD $)
In Millions, except Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Restricted stock units |
2014 Plan and Inducement Plan
 
 
 
 
Stockholders' Equity, other disclosures
 
 
 
 
Requisite service period, quarterly
 
 
4 years 
 
Requisite service period, annually
 
 
3 years 
 
Stock-based compensation expense
$ 1.2 
$ 0.4 
$ 1.8 
$ 0.6 
Unrecognized compensation costs (in dollars)
$ 6.2 
 
$ 6.2 
 
Weighted average period over which unrecognized compensation costs are expected to be recognized
 
 
2 years 
 
Number of shares
 
 
 
 
Balance at beginning of the period
 
 
430,733 
 
Granted
 
 
700,246 
 
Vested
 
 
(251,160)
 
Restricted stock units withheld for tax
 
 
68,968 
 
Forfeited
 
 
(22,000)
 
Balance at end of the period
926,787 
 
926,787 
 
Weighted average grant date fair value
 
 
 
 
Balance at beginning of the period
 
 
$ 7.99 
 
Granted
 
 
$ 8.43 
 
Vested
 
 
$ 7.76 
 
Restricted stock units withheld for tax
 
 
$ 8.28 
 
Forfeited
 
 
$ 8.49 
 
Balance at end of the period
$ 8.40 
 
$ 8.40 
 
Stockholders' Equity (Stock Purchase) (Details) (USD $)
In Millions, except Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2017
2014 Employee Stock Purchase Plan
Jun. 30, 2016
2014 Employee Stock Purchase Plan
Jun. 30, 2017
2014 Employee Stock Purchase Plan
Jun. 30, 2016
2014 Employee Stock Purchase Plan
Jun. 30, 2017
2014 Employee Stock Purchase Plan
Maximum
Oct. 31, 2014
2014 Employee Stock Purchase Plan
Maximum
Stockholders' Equity
 
 
 
 
 
 
 
Discount rate on the value of shares through payroll deductions (as a percent)
 
 
 
 
 
15.00% 
 
Expiration period of each offering
 
 
 
 
 
27 months 
 
Purchase period of offering
 
 
 
6 months 
 
 
 
Rate of purchase price of stock on fair value (as a percent)
 
 
 
85.00% 
 
 
 
Number of shares reserved for future issuance
 
770,549 
 
770,549 
 
 
255,500 
Purchases under the award
 
 
 
54,559 
 
 
 
Weighted Average purchase price
 
$ 5.93 
 
$ 5.93 
 
 
 
Number of shares available for future grants
549,073 
 
 
 
 
 
 
Stock-based compensation expense
 
$ 0.1 
$ 0.1 
$ 0.2 
$ 0.2 
 
 
Income Taxes (Details) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Income Tax Disclosure [Abstract]
 
 
 
 
Tax expense
$ 29,000 
$ 0 
$ 54,000 
$ 0 
Commitments and Contingencies (Details) (USD $)
3 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 12 Months Ended 0 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Dec. 31, 2016
Jul. 27, 2017
Subsequent Events
USD_Per_Unit
Jul. 27, 2017
Maximum
Subsequent Events
Jul. 19, 2016
Class Action Lawsuits
lawsuit
Dec. 4, 2015
Class Action Lawsuits
lawsuit
Nov. 24, 2015
Class Action Lawsuits
Stockholder
Nov. 19, 2015
Class Action Lawsuits
lawsuit
Mar. 31, 2017
Class Action Lawsuits
Dec. 31, 2016
Class Action Lawsuits
Jul. 27, 2017
Litigation Settlement in 30 days
Subsequent Events
Jul. 27, 2017
Litigation Settlement in 2018
Subsequent Events
Operating Leases
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lease expiration date
 
 
Feb. 29, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
Rent expense
$ 100,000 
$ 100,000 
$ 300,000 
$ 300,000 
 
 
 
 
 
 
 
 
 
 
 
Contingencies
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of stockholders filed motions to appoint lead plaintiff
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of lawsuits filed
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of lawsuits dismissed
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of lawsuits consolidated
 
 
 
 
 
 
 
 
 
 
 
 
 
 
General and administrative
8,022,000 
5,357,000 
14,458,000 
10,642,000 
 
 
 
 
 
 
 
 
1,600,000 
 
 
Contingency loss in period
 
 
 
 
 
 
 
 
 
 
 
 
10,900,000 
 
 
Insurance recovery receivable
97,000 
 
97,000 
 
9,375,000 
 
 
 
 
 
 
 
9,400,000 
 
 
Received in insurance proceeds
 
 
9,277,000 
 
 
 
 
 
 
 
 
9,300,000 
 
 
 
Loss contingency paid
10,000,000 
 
10,000,000 
 
10,900,000 
 
 
 
 
 
 
10,900,000 
 
 
 
Litigation settlement agreement, amount to be paid
 
 
 
 
 
 
 
 
 
 
 
 
 
9,000,000 
1,000,000 
Royalty payments on each of net sales per product
 
 
 
 
 
12.50 
 
 
 
 
 
 
 
 
 
Royalty expense
 
 
 
 
 
 
$ 5,000,000 
 
 
 
 
 
 
 
 
Subsequent Events (Details) (USD $)
1 Months Ended 6 Months Ended 0 Months Ended 0 Months Ended 0 Months Ended 6 Months Ended 0 Months Ended
Mar. 31, 2017
Jun. 30, 2017
Apr. 30, 2017
Jul. 25, 2017
Subsequent Events
Jul. 27, 2017
Subsequent Events
USD_Per_Unit
Jul. 27, 2017
Subsequent Events
Litigation Settlement in 30 days
Jul. 27, 2017
Subsequent Events
Litigation Settlement in 2018
Jul. 25, 2017
Subsequent Events
Term Loan Credit Agreement
Jul. 25, 2017
Subsequent Events
Term Loan Credit Agreement
LIBOR
Jul. 25, 2017
Subsequent Events
Term Loan Credit Agreement
Subject to Satisfaction of Certain Conditions Including FDA Certification
Jul. 25, 2017
Subsequent Events
Term Loan Credit Agreement
Subject to Satisfaction of Certain Conditions Including Evidence of Net Revenue for Past 12 Months
Jul. 25, 2017
Subsequent Events
Loan Agreement With Silicon Valley Bank
Jul. 25, 2017
Subsequent Events
Revolving Credit Agreement
LIBOR
Jul. 25, 2017
Minimum
Subsequent Events
LIBOR
Jul. 27, 2017
Maximum
Subsequent Events
Jun. 11, 2017
Miramar Labs, Inc.,
Jun. 30, 2017
Miramar Labs, Inc.,
Jun. 11, 2017
Miramar Labs, Inc.,
Minimum
Payment
Jun. 11, 2017
Miramar Labs, Inc.,
Maximum
Subsequent Event [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Business acquisition agreement date
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jun. 11, 2017 
 
 
Business purchase price per share
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 0.3149 
 
 
 
Number of contingent payments
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Business combination, upfront cash payments
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 20,000,000 
 
 
 
Business combination, potential contingent payments
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14,000,000 
Effective date of acquisition
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jul. 25, 2017 
 
 
Borrowed amounts under agreement
 
 
5,000,000 
 
 
 
 
25,000,000 
 
 
 
 
 
 
 
 
 
 
 
Repayment of existing indebtedness
 
 
 
 
 
 
 
 
 
 
 
5,000,000 
 
 
 
 
 
 
 
Lines of credit facility available date
 
 
 
 
 
 
 
 
 
Mar. 31, 2018 
 
 
 
 
 
 
 
 
 
Additional term loan facility
 
 
 
 
 
 
 
 
 
10,000,000 
5,000,000 
 
 
 
 
 
 
 
 
Minimum revenue required to satisfy additional term loan facility
 
 
 
 
 
 
 
 
 
 
75,000,000 
 
 
 
 
 
 
 
 
Borrowing base of accounts receivable (as a percent)
80.00% 
 
 
85.00% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Spread on variable rate basis (as a percent)
 
 
 
 
 
 
 
 
7.50% 
 
 
 
4.50% 
 
 
 
 
 
 
Debt instrument, interest rate floor
 
 
 
 
 
 
 
 
 
 
 
 
 
1.00% 
 
 
 
 
 
Maintenance of cash and cash equivalents
 
 
 
10,000,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Settlement agreement date
 
July 27, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Litigation settlement agreement, amount to be paid
 
 
 
 
 
9,000,000 
1,000,000 
 
 
 
 
 
 
 
 
 
 
 
 
Royalty payments on each of net sales per product
 
 
 
 
12.50 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Royalty expense
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 5,000,000