UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2018
OR
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 001-36709
SIENTRA, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware (State or Other Jurisdiction of Incorporation or Organization) |
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20-5551000 (I.R.S. Employer Identification No.) |
420 South Fairview Avenue, Suite 200 Santa Barbara, California (Address of Principal Executive Offices) |
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93117 (Zip Code) |
(805) 562-3500
(Registrant’s Telephone Number, Including Area Code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ☐ |
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Accelerated filer ☒ |
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Non-accelerated filer ☐ |
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Smaller reporting company ☐ |
(Do not check if a smaller reporting company) |
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Emerging growth company ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 7, 2018, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was 28,183,911.
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2018
“Sientra”, “OPUS”, “Allox”, “Allox2”, “BIOCORNEUM”, “Dermaspan”, “Softspan”, “Silishield”, “miraDry”, “Miramar Labs”, “miraDry and Design”, “miraDry Fresh”, “The Sweat Stops Here”, “Drop Design”, “miraWave”, “miraSmooth”, “miraFresh”, and “ML Stylized mark” are trademarks of our company. Our logo and our other trade names, trademarks and service marks appearing in this document are our property. Other trade names, trademarks and service marks appearing in this document are the property of their respective owners. Solely for convenience, our trademarks and trade names referred to in the document, appear without the TM or the (R) symbol, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the rights of the applicable licensor to these trademarks and trade names.
PART I — FINANCIAL INFORMATION
SIENTRA, INC.
Condensed Consolidated Balance Sheets
(In thousands, except per share and share amounts)
(Unaudited)
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March 31, |
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December 31, |
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2018 |
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2017 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
16,059 |
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$ |
26,588 |
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Accounts receivable, net of allowances of $1,137 and $4,816 at March 31, 2018 and December 31, 2017, respectively |
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12,072 |
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6,569 |
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Inventories, net |
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21,829 |
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20,896 |
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Prepaid expenses and other current assets |
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2,374 |
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1,512 |
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Total current assets |
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52,334 |
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55,565 |
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Property and equipment, net |
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4,934 |
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4,763 |
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Goodwill |
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12,507 |
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12,507 |
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Other intangible assets, net |
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18,223 |
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18,803 |
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Other assets |
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719 |
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|
575 |
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Total assets |
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$ |
88,717 |
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$ |
92,213 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Current portion of long-term debt |
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$ |
5,256 |
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$ |
24,639 |
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Accounts payable |
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10,487 |
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5,811 |
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Accrued and other current liabilities |
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16,535 |
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13,474 |
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Legal settlement payable |
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1,000 |
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1,000 |
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Customer deposits |
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5,431 |
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5,423 |
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Refund liability |
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4,400 |
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— |
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Total current liabilities |
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43,109 |
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50,347 |
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Long-term debt |
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22,735 |
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— |
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Deferred and contingent consideration |
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11,338 |
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12,597 |
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Warranty reserve and other long-term liabilities |
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1,692 |
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1,646 |
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Total liabilities |
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78,874 |
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64,590 |
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Commitments and contingencies (Note 12) |
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Stockholders’ equity: |
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Preferred stock, $0.01 par value – Authorized 10,000,000 shares; none issued or outstanding |
|
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— |
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— |
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Common stock, $0.01 par value — Authorized 200,000,000 shares; issued 19,716,369 and 19,474,702 and outstanding 19,643,642 and 19,401,975 shares at March 31, 2018 and December 31, 2017 respectively |
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197 |
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|
194 |
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Additional paid-in capital |
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308,799 |
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307,159 |
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Treasury stock, at cost (72,727 shares at March 31, 2018 and December 31, 2017) |
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(260 |
) |
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(260 |
) |
Accumulated deficit |
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(298,893 |
) |
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(279,470 |
) |
Total stockholders’ equity |
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9,843 |
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27,623 |
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Total liabilities and stockholders’ equity |
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$ |
88,717 |
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$ |
92,213 |
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See accompanying notes to condensed consolidated financial statements.
1
Condensed Consolidated Statements of Operations
(In thousands, except per share and share amounts)
(Unaudited)
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March 31, |
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2018 |
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2017 |
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Net sales |
$ |
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14,676 |
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$ |
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7,489 |
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Cost of goods sold |
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6,097 |
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2,322 |
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Gross profit |
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8,579 |
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5,167 |
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Operating expenses: |
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Sales and marketing |
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15,256 |
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6,955 |
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Research and development |
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2,751 |
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3,194 |
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General and administrative |
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9,499 |
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6,436 |
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Total operating expenses |
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27,506 |
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16,585 |
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Loss from operations |
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(18,927 |
) |
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(11,418 |
) |
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Other income (expense), net: |
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Interest income |
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40 |
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22 |
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Interest expense |
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(655 |
) |
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(9 |
) |
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Other income (expense), net |
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119 |
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8 |
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Total other income (expense), net |
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(496 |
) |
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21 |
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Loss before income taxes |
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(19,423 |
) |
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(11,397 |
) |
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Income tax expense |
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— |
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25 |
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Net loss |
$ |
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(19,423 |
) |
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$ |
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(11,422 |
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Basic and diluted net loss per share attributable to common stockholders |
$ |
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(0.99 |
) |
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$ |
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(0.61 |
) |
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Weighted average outstanding common shares used for net loss per share attributable to common stockholders: |
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Basic and diluted |
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19,613,417 |
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18,772,965 |
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See accompanying notes to condensed consolidated financial statements.
2
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Three Months Ended |
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March 31, |
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2018 |
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2017 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(19,423 |
) |
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$ |
(11,422 |
) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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880 |
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|
570 |
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Provision for doubtful accounts |
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233 |
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|
8 |
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Provision for warranties |
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183 |
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|
|
57 |
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Provision for inventory |
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199 |
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|
107 |
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Amortization of acquired inventory step-up |
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59 |
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|
201 |
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Change in fair value of warrants |
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(121 |
) |
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(9 |
) |
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Change in fair value of deferred and contingent consideration |
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621 |
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|
64 |
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Change in deferred revenue |
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(99 |
) |
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— |
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Amortization of debt discount and issuance costs |
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51 |
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|
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— |
|
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Non-cash interest expense |
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— |
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|
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8 |
|
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Stock-based compensation expense |
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2,548 |
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1,360 |
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Deferred income taxes |
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— |
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25 |
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Changes in assets and liabilities, net of effects from acquisitions: |
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Accounts receivable |
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(5,735 |
) |
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365 |
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Inventories |
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(1,191 |
) |
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|
977 |
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Prepaid expenses, other current assets and other assets |
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(1,009 |
) |
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(1,420 |
) |
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Insurance recovery receivable |
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(10 |
) |
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9,301 |
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Accounts payable |
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4,684 |
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(856 |
) |
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Accrued and other liabilities |
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|
948 |
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3,040 |
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Legal settlement payable |
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— |
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(10,900 |
) |
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Customer deposits |
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|
8 |
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|
335 |
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Refund liability |
|
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4,400 |
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|
|
— |
|
|
Net cash used in operating activities |
|
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(12,774 |
) |
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(8,189 |
) |
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Cash flows from investing activities: |
|
|
|
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|
|
|
|
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Purchase of property and equipment |
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(142 |
) |
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(952 |
) |
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Net cash used in investing activities |
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(142 |
) |
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(952 |
) |
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Cash flows from financing activities: |
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Proceeds from exercise of stock options |
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— |
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|
752 |
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Proceeds from issuance of common stock under ESPP |
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|
391 |
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|
|
324 |
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Tax payments related to shares withheld for vested restricted stock units (RSUs) |
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(1,296 |
) |
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(390 |
) |
|
Gross borrowings under the Revolving Loan |
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9,033 |
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|
|
— |
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Repayment of the Revolving Loan |
|
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(5,735 |
) |
|
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— |
|
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Deferred financing costs |
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(6 |
) |
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— |
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Net cash provided by financing activities |
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2,387 |
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|
|
686 |
|
|
Net decrease in cash and cash equivalents |
|
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(10,529 |
) |
|
|
(8,455 |
) |
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Cash and cash equivalents at: |
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|
|
|
|
|
|
|
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Beginning of period |
|
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26,588 |
|
|
|
67,212 |
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End of period |
|
$ |
16,059 |
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|
$ |
58,757 |
|
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
586 |
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|
$ |
— |
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Supplemental disclosure of non-cash investing and financing activities: |
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|
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|
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Property and equipment in accounts payable and accrued liabilities |
|
|
1,530 |
|
|
|
214 |
|
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Fair value of warrants to be issued |
|
|
— |
|
|
|
88 |
|
|
See accompanying notes to condensed consolidated financial statements.
3
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. |
Formation and Business of the Company |
|
a. |
Formation |
Sientra, Inc. (“Sientra”, the “Company,” “we,” “our” or “us”), was incorporated in the State of Delaware on August 29, 2003 under the name Juliet Medical, Inc. and subsequently changed its name to Sientra, Inc. in April 2007. The Company acquired substantially all the assets of Silimed, Inc. on April 4, 2007. The purpose of the acquisition was to acquire the rights to the silicone breast implant clinical trials, related product specifications and pre-market approval, or PMA, assets. Following this acquisition, the Company focused on completing the clinical trials to gain FDA approval to offer its silicone gel breast implants in the United States.
In March 2012, the Company announced it had received approval from the FDA for its portfolio of silicone gel breast implants, and in the second quarter of 2012 the Company began commercialization efforts to sell its products in the United States. The Company, based in Santa Barbara, California, is a medical aesthetics company that focuses on serving board-certified plastic surgeons and offers a portfolio of silicone shaped and round breast implants, scar management, tissue expanders, and body contouring products.
In November 2014, the Company completed an initial public offering, or IPO, and its common stock is listed on the Nasdaq Stock Exchange under the symbol “SIEN.”
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b. |
Acquisition of miraDry |
On June 11, 2017, Sientra entered into an Agreement and Plan of Merger, or the Merger Agreement, with miraDry, (formerly Miramar Labs), pursuant to which Sientra commenced a tender offer to purchase all of the outstanding shares of 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 $18.7 million in upfront cash and the contractual rights represent potential contingent payments of up to $14 million. The transaction, which closed on July 25, 2017, added the miraDry System to Sientra’s aesthetics portfolio.
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c. |
Regulatory Review of Vesta Manufacturing |
The Company has engaged Vesta Intermediate Funding, Inc., or Vesta, a Lubrizol Lifesciences company, for the manufacture and supply of the Company’s breast implants. On March 14, 2017, the Company announced it had submitted a PMA supplement to the FDA for the manufacturing of the Company’s PMA-approved breast implants by Vesta. On January 30, 2018, the Company announced the FDA has granted approval of the site-change pre-market approval, or PMA, supplement for the Company’s contract manufacturer, Vesta, to manufacture its silicone gel breast implants. In support of the move to the Vesta manufacturing facility, the Company also implemented new manufacturing process improvements which, in consultation with the FDA, required three (3) additional PMA supplements. In addition to approving the manufacturing site-change supplement, the FDA has approved our three (3) process enhancement supplements on January 10, 2018, January 19, 2018 and April 17, 2018.
2. |
Summary of Significant Accounting Policies |
|
a. |
Basis of Presentation |
The accompanying unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the rules and regulations of the U.S. Securities and Exchange Commission, or SEC. Accordingly, they do not include certain footnotes and financial presentations normally required under accounting principles generally accepted in the United States of America for complete financial reporting. The interim financial information is unaudited, but reflects all normal adjustments and accruals which are, in the opinion of management, considered
4
necessary to provide a fair presentation for the interim periods presented. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 13, 2018 and Form 10-K/A filed on April 30, 2018, or the Annual Report. The results for the three months ended March 31, 2018 are not necessarily indicative of results to be expected for the year ending December 31, 2018, any other interim periods, or any future year or period.
|
b. |
Liquidity |
Since the Company’s inception, it has incurred significant net operating losses and anticipate that losses will continue in the near term. The Company expects its operating expenses will continue to grow as they expand operations. The Company will need to generate significant net sales to achieve profitability. To date, the Company has funded operations primarily with proceeds from the sales of preferred stock, borrowings under term loans, sales of products since 2012, and the proceeds from the sale of common stock in public offerings.
The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which implies the Company will continue to realize its assets and discharge its liabilities in the normal course of business. As of March 31, 2018, the Company had cash and cash equivalents of $16.1 million. Since inception, the Company has incurred recurring losses from operations and cash outflows from operating activities. The continuation of the Company as a going concern is dependent upon many factors including liquidity and the ability to raise capital. The Company received FDA approval of their PMA supplement on April 17, 2018 and was then able to access a $10.0 million term loan pursuant to an amendment to the credit agreement with MidCap Financial Trust, or MidCap. In addition, in February 2018, the Company entered into an At-The-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, as sales agent pursuant to which the Company may sell, from time to time, through Stifel, shares of our common stock having an aggregate gross offering price of up to $50 million. Further, on May 7, 2018, the Company completed a public offering of its common stock, raising approximately $107.7 million in net proceeds after deducting underwriting discounts and commissions and other estimated offering expenses.
The Company believes that its cash and cash equivalents combined with the additional capital raised subsequent to March 31, 2018 discussed above, will be sufficient to fund its operations for at least the next 12 months. To fund ongoing operating and capital needs, the Company may need to raise additional capital in the future through the sale of equity securities and incremental debt financing.
|
c. |
Use of Estimates |
The preparation of the condensed consolidated financial statements, in conformity with GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
|
d. |
Significant Accounting Policies |
Revenue Recognition
The Company recognizes revenue when the Company transfers control of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods or services. See Note 3 - Revenue for further discussion.
There have been no other changes to the accounting policies during the three months ended March 31, 2018, as compared to the significant accounting policies described in the “Notes to Financial Statements” in the Annual Report.
5
Recently Adopted Accounting Standards
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). Topic 606 supersedes the revenue recognition requirements in Topic 605 Revenue Recognition (Topic 605) and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted Topic 606 in the first quarter of 2018 to all contracts using the modified retrospective method. The adoption of Topic 606 did not have a material impact on the Company’s historical net losses and, therefore, no adjustment was made to the opening balance of retained earnings. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. The Company does not expect the adoption of Topic 606 to have a material impact to the Company’s net income (loss) on an ongoing basis.
In accordance with Topic 606 requirements, the disclosure of the impact of adoption on our condensed consolidated balance sheet was as follows (in thousands):
|
|
March 31, 2018 |
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Balances Without |
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Adoption of |
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Effect of Change |
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||
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As Reported |
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|
ASC 606 |
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Higher/(Lower) |
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|||
Balance Sheet |
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Assets |
|
|
|
|
|
|
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|
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|
|
Accounts receivable, net of allowances |
|
$ |
12,072 |
|
|
$ |
7,672 |
|
|
$ |
4,400 |
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
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Refund liability |
|
$ |
4,400 |
|
|
|
— |
|
|
$ |
4,400 |
|
Additionally, in accordance with Topic 606, the balance of breast product inventory estimated to be returned as of March 31, 2018 is included in the components of the Company’s inventory as “Finished goods – right of return” in Note 9b - Inventories. Prior to the adoption of Topic 606, the inventory impact of estimated returns for breast products was included in the “Finished goods” inventory balance and was not separately disclosed.
The adoption of Topic 606 did not have a material impact on our condensed consolidated income statement.
In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows – Classifications of Certain Cash Receipts and Cash Payments (Topic 230). The standard update addresses eight specific cash flow issues not currently addressed by GAAP, with the objective of reducing the existing diversity in practice of how these cash receipts and payments are presented and classified in the statement of cash flows. The ASU requires a retrospective approach to adoption. The Company adopted the ASU in the first quarter of 2018. The adoption of this ASU did not have a material impact on the Company’s condensed consolidated financial statements for the first fiscal quarter 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 Company adopted the ASU in the first quarter of 2018 on prospective basis. The adoption of this ASU did not have a material impact on the Company’s condensed consolidated financial statements.
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 Accounting Standard Codification, or ASC, 718. The Company adopted the ASU in the first quarter of 2018 on a prospective basis. The adoption of this ASU did not have a material impact on the Company’s condensed consolidated financial statements.
6
Recently Issued Accounting Standards
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) which supersedes FASB Accounting Standard Codification Leases (Topic 840). The standard is intended to increase the transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. This accounting standard update will be effective for the Company beginning in fiscal year 2019. The Company is currently evaluating the impact that adoption of the standard will have on the financial statements and related disclosures.
In February 2018, the FASB issued ASU 2018-05, Income Taxes (Topic 740), which allows for an entity to elect to reclassify the income tax effects on items within accumulated other comprehensive income resulting from U.S. Tax Cuts and Jobs Act to retained earnings. The guidance is effective for fiscal years beginning after December 15, 2018 with early adoption permitted, including interim periods within those years. The Company does not expect to elect to reclassify the income tax effects under ASU 2018-05, as it does not have a material impact on the condensed consolidated financial statements.
f.Reclassifications
Certain reclassifications have been made to prior year amounts to conform to the current year presentation.
3. |
Revenue |
Revenue Recognition
The Company generates revenue primarily through the sale and delivery of promised goods or services to customers and recognizes revenue when control is transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for the goods or services. Sales prices are documented in the executed sales contract or purchase order prior to the transfer of control to the customer. Customers may enter into a separate extended service agreement to purchase an extended warranty for miraDry products from the Company whereby the payment is due at the inception of the agreement. Revenue for extended service agreements are recognized ratably over the term of the agreements.
The Company also leverages a distributor network for selling the miraDry System internationally. The Company recognizes revenue when control of the goods or services is transferred to the distributors. Standard terms in these agreements do not allow for trial periods, right of return, refunds, payment contingent on obtaining financing or other terms that could impact the customer’s payment obligation.
A portion of the Company’s revenue is generated from the sale of consigned inventory of breast implants maintained at doctor, hospital, and clinic locations. For these products, revenue is recognized at the time the Company is notified by the customer that the product has been implanted, not when the consigned products are delivered to the customer’s location.
For Breast Products, with the exception of the Company’s BIOCORNEUM scar management products, the Company allows for the return of products from customers within six months after the original sale, which is accounted for as variable consideration. Appropriate reserves are established for anticipated sales returns based on the expected amount calculated with historical experience, recent gross sales and any notification of pending returns. The estimated sales return is recorded as a reduction of revenue and as a refund liability in the same period revenue is recognized. Actual sales returns in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the current or subsequent period would be recorded. The Company has established an allowance for sales returns of $4.4 million and $3.9 million as of March 31, 2018 and December 31, 2017, respectively, recorded as “Refund liability” on the condensed consolidated balance sheet under Topic 606 as of March 31, 2018 and recorded in “Accounts receivable, net of allowances,” at December 31, 2017 on the condensed consolidated balance sheet, as indicated above in “Recently Adopted Accounting Standards.”
7
Sales tax, value-added tax, and other taxes the Company may collect concurrent with revenue-producing activities are excluded from the measurement of the transaction price and thus from revenue.
Arrangements with Multiple Performance Obligations
The Company has determined that the delivery of each unit of product in the Company’s revenue contracts with customers is a separate performance obligation. The Company’s revenue contracts may include multiple products, each of which is considered a separate performance obligation. For such arrangements, the Company allocates revenue to each performance obligation based on its relative standalone selling price. The Company generally determines standalone selling prices based on observable prices or using an expected cost plus margin approach when an observable price is not available. The Company invoices customers once products are shipped or delivered to customers depending on the negotiated shipping terms.
Practical Expedients and Policy Election
The Company generally expenses sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within sales and marketing expenses.
The Company does not adjust accounts receivable for the effects of any significant financing components as customer payment terms are generally shorter than one year.
The Company has elected to account for shipping and handling activities performed after a customer obtains control of the products as activities to fulfill the promise to transfer the products to the customer. Shipping and handling activities are largely provided to customers free of charge for the Breast Products segment. The associated costs were $0.2 million for both the three months ended March 31, 2018 and 2017. These costs are viewed as part of the Company’s marketing programs and are recorded as a component of sales and marketing expense in the condensed consolidated statement of operations as an accounting policy election. Shipping and handling charges are typically billed to customers for sales of the miraDry systems and are recorded as a component of cost of goods sold in the condensed consolidated statement of operations. The associated costs for the three months ended March 31, 2018 was $0.1 million.
4. |
Acquisitions |
|
a. |
Acquisition of miraDry |
On June 11, 2017, Sientra entered into the Merger Agreement with miraDry, pursuant to which Sientra commenced a tender offer to purchase all of the outstanding shares of miraDry’s common stock for (i) $0.3149 per share, plus (ii) the contractual right to receive one or more contingent payments upon the achievement of certain future sales milestones. The total merger consideration was $18.7 million in upfront cash and the contractual rights represent potential contingent payments of up to $14 million. The transaction, which closed on July 25, 2017, or the Acquisition Date, added the miraDry System, the only FDA cleared device indicated to reduce underarm sweat, odor and hair of all colors, to Sientra’s aesthetics portfolio. The Company did not record any professional fees related to the acquisition for the three months ended March 31, 2018 and 2017. The aggregate acquisition date fair value of the consideration transferred was approximately $29.6 million, consisting of the following (in thousands):
|
|
Fair Value |
|
|
Cash consideration at Acquisition Date (other than debt payoff) |
|
$ |
6,193 |
|
Cash consideration at Acquisition Date (debt payoff) |
|
|
12,467 |
|
Deferred consideration |
|
|
966 |
|
Contingent consideration |
|
|
9,946 |
|
Total purchase consideration |
|
$ |
29,572 |
|
The Company funded the cash consideration, including the debt payoff amount with cash on hand. The cash consideration included the payoff of miraDry’s existing term loan, or the Note Purchase Agreement dated January 27, 2017 and bridge loan, or the January 2017 Bridge Loan, including interest. The deferred consideration relates to
8
cash held back to be used for either potential litigation-related expenses or for payments to certain former investors of miraDry, as defined in the Note Purchase Agreement dated January 27, 2017, one year following the Acquisition Date. Contingent consideration of future cash payments of a maximum of $14.0 million represents the contractual right of certain former miraDry shareholders to receive one or more contingent payments upon achievement of certain future sales milestones and includes certain amounts due to investors related to the remaining balances on the January 2017 Bridge Note and accrued royalty obligations, with certain amounts held back for potential litigation-related expenses. The fair value of the contingent consideration at the acquisition date was determined 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 6. The contingent consideration component is subject to the recognition of subsequent changes in fair value through general and administrative expense in the condensed consolidated statement of operations.
In accordance with ASC 805, the Company has recorded the acquired assets (including identifiable intangible assets) and liabilities assumed at their respective fair value. The preliminary allocation of the total purchase price is as follows (in thousands):
|
|
July 25, |
|
|
|
|
2017 |
|
|
Cash |
|
$ |
205 |
|
Accounts receivable, net |
|
|
2,091 |
|
Inventories, net |
|
|
7,064 |
|
Other current assets |
|
|
170 |
|
Property and equipment, net |
|
|
528 |
|
Goodwill |
|
|
7,629 |
|
Intangible assets |
|
|
14,800 |
|
Restricted cash |
|
|
305 |
|
Other assets |
|
|
12 |
|
Liabilities assumed: |
|
|
|
|
Accounts payable |
|
|
(908 |
) |
Accrued and other current liabilities |
|
|
(2,294 |
) |
Other current liabilities |
|
|
(30 |
) |
Net assets acquired |
|
$ |
29,572 |
|
Goodwill has been allocated to the miraDry reportable segment. The goodwill recognized is attributable primarily to the assembled workforce and additional market opportunities. Goodwill is not expected to be deductible for tax purposes.
A summary of the intangible assets acquired, estimated useful lives and amortization method is as follows (in thousands):
|
|
|
|
|
|
Estimated useful |
|
Amortization |
|
|
Amount |
|
|
life |
|
method |
|
Developed technology |
|
$ |
3,000 |
|
|
15 years |
|
Accelerated |
Customer relationships |
|
|
6,300 |
|
|
14 years |
|
Accelerated |
Distributor relationships |
|
|
500 |
|
|
9 years |
|
Accelerated |
Trade name |
|
|
5,000 |
|
|
15 years |
|
Accelerated |
|
|
$ |
14,800 |
|
|
|
|
|
The Company retained an independent third-party appraiser to assist management in its valuation and the purchase price has been finalized.
9
Unaudited Pro Forma Information
The following unaudited pro forma financial information presents combined results of operations for each of the periods presented, as if miraDry had been acquired as of the beginning of fiscal year 2017. The pro forma information includes adjustments to amortization for intangible assets acquired, the purchase accounting effect on inventory acquired, interest expense for the additional indebtedness incurred to complete the acquisition, restructuring charges in connection with the acquisition and acquisition costs. The pro forma data are for informational purposes only and are not necessarily indicative of the condensed consolidated results of operations of the combined business had the merger actually occurred at the beginning of fiscal year 2017 or of the results of future operations of the combined business. Consequently, actual results will differ from the unaudited pro forma information presented below (in thousands, except per share amounts):
|
|
March 31, |
|
|
|
|
|
2017 |
|
|
|
|
Pro Forma |
|
|
||
Net sales |
|
$ |
11,303 |
|
|
Net loss |
|
|
(20,659 |
) |
|
Pro forma loss per share attributable to ordinary shares - basic and diluted |
|
$ |
(1.11 |
) |
|
5. |
Fair Value of Financial Instruments |
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, customer deposits and refund liability are reasonable estimates of their fair value because of the short maturity of these items. The fair value of the common stock warrant liability, deferred and contingent consideration are discussed in Note 2. The fair value of the debt is based on the amount of future cash flows associated with the instrument discounted using the Company’s estimated market rate. As of March 31, 2018, the carrying value of the long-term debt was not materially different from the fair value.
6. |
Fair Value Measurements |
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
|
• |
Level 1 — Quoted prices in active markets for identical assets or liabilities. |
|
• |
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
10
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 contingent consideration for future royalty payments related to the acquisition of BIOCORNEUM, the contingent consideration for future milestone payments for the acquisition of the tissue expander portfolio and the contingent consideration for the future milestone payments related to the acquisition of miraDry using a Monte-Carlo simulation model. Significant assumptions used in the measurement include future net sales for a defined term and the risk-adjusted discount rate associated with the business. As the inputs are not observable, the overall fair value measurement of the 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 March 31, 2018 and December 31, 2017 and indicate the level of the fair value hierarchy utilized to determine such fair value (in thousands):
|
|
Fair Value Measurements as of |
|
|||||||||||||
|
|
March 31, 2018 Using: |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability for common stock warrants |
|
$ |
— |
|
|
|
— |
|
|
|
73 |
|
|
|
73 |
|
Liability for contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
12,940 |
|
|
|
12,940 |
|
|
|
$ |
— |
|
|
|
— |
|
|
|
13,013 |
|
|
|
13,013 |
|
|
|
Fair Value Measurements as of |
|
|||||||||||||
|
|
December 31, 2017 Using: |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability for common stock warrants |
|
$ |
— |
|
|
|
— |
|
|
|
194 |
|
|
|
194 |
|
Liability for contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
12,319 |
|
|
|
12,319 |
|
|
|
$ |
— |
|
|
|
— |
|
|
|
12,513 |
|
|
|
12,513 |
|
The liability for common stock warrants and the current portion of contingent consideration is included in “accrued and other current liabilities” and the long-term liabilities for the contingent consideration are included in “deferred and contingent consideration” in the condensed consolidated balance sheet. The following table provides a rollforward of the aggregate fair values of the Company’s common stock warrants and contingent consideration for which fair value is determined by Level 3 inputs (in thousands):
Warrant Liability |
|
|
|
|
Balance, December 31, 2017 |
|
$ |
194 |
|
Change in fair value of warrant liability |
|
|
(121 |
) |
Balance, March 31, 2018 |
|
$ |
73 |
|
Contingent Consideration Liability |
|
|
|
|
Balance, December 31, 2017 |
|
$ |
12,319 |
|
Change in fair value of contingent consideration |
|
|
621 |
|
Balance, March 31, 2018 |
|
$ |
12,940 |
|
11
The Company recognizes changes in the fair value of the warrants in “other income (expense), net” in the condensed consolidated statement of operations and changes in contingent consideration are recognized in “general and administrative” expense in the condensed consolidated statement of operations.
7. |
Product Warranties |
The Company offers a product replacement and limited warranty program for the Company’s silicone gel breast implants, and a product warranty for the Company’s miraDry Systems and consumable bioTips. For implant surgeries taking place after May 1, 2018, the breast implant product replacement and limited warranty program provides lifetime no-charge replacement implants for covered rupture events, and no-charge replacement breast implants for other covered events that occur within twenty years of the implant surgery. For certain covered events, the Company will also reimburse patients for certain out-of-pocket expenses incurred by patients within twenty years of the implant surgery, up to a maximum amount of $5,000. For implants occurring prior to May 1, 2018, 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 breast implant lifetime product replacement program, the Company provides no-charge replacement breast implants if a patient experiences a covered event. Under the miraDry warranty, the Company provides a standard product warranty for the miraDry system and bioTips. Additionally, an extended warranty may be purchased to provide additional protection of the miraDry System.
The following table provides a rollforward of the accrued warranties (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2018 |
|
|
2017 |
|
||
Beginning balance as of January 1 |
|
$ |
1,642 |
|
|
$ |
1,378 |
|
Warranty costs incurred during the period |
|
|
(104 |
) |
|
|
— |
|
Changes in accrual related to warranties issued during the period |
|
|
50 |
|
|
|
51 |
|
Changes in accrual related to pre-existing warranties |
|
|
133 |
|
|
|
6 |
|
Balance as of March 31 |
|
$ |
1,721 |
|
|
$ |
1,435 |
|
8. |
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 March 31, |
|
|
|||||
|
|
2018 |
|
|
2017 |
|
|
||
Net loss (in thousands) |
|
$ |
(19,423 |
) |
|
$ |
(11,422 |
) |
|
Weighted average common shares outstanding, basic and diluted |
|
|
19,613,417 |
|
|
|
18,772,965 |
|
|
Net loss per share attributable to common stockholders |
|
$ |
(0.99 |
) |
|
$ |
(0.61 |
) |
|
12
The Company excluded the following potentially dilutive securities, outstanding as of March 31, 2018 and 2017, from the computation of diluted net loss per share attributable to common stockholders for the three months ended March 31, 2018 and 2017 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods.
|
|
March 31, |
|
|
|||||
|
|
2018 |
|
|
2017 |
|
|
||
Stock options to purchase common stock |
|
|
1,600,826 |
|
|
|
1,701,131 |
|
|
Warrants for the purchase of common stock |
|
|
47,710 |
|
|
|
47,710 |
|
|
|
|
|
1,648,536 |
|
|
|
1,748,841 |
|
|
9. |
Balance Sheet Components |
|
a. |
Allowance for Doubtful Accounts |
The Company has established an allowance for doubtful accounts of $1.1 million and $0.9 million as of March 31, 2018 and December 31, 2017, respectively, recorded net against accounts receivable in the balance sheet.
|
b. |
Inventories |
Inventories, net consist of the following (in thousands):
|
|
March 31, |
|
December 31, |
|
|||
|
|
2018 |
|
|
2017 |
|
||
Raw materials |
|
$ |
1,727 |
|
|
$ |
1,642 |
|
Work in progress |
|
|
2,991 |
|
|
|
3,956 |
|
Finished goods |
|
|
16,021 |
|
|
|
15,298 |
|
Finished goods - right of return |
|
|
1,090 |
|
|
|
— |
|
|
|
$ |
21,829 |
|
|
$ |
20,896 |
|
|
c. |
Property and Equipment |
Property and equipment, net consist of the following (in thousands):
|
|
March 31, |
|
December 31, |
|
|||
|
|
2018 |
|
|
2017 |
|
||
Leasehold improvements |
|
$ |
402 |
|
|
$ |
402 |
|
Manufacturing equipment and toolings |
|
|
4,587 |
|
|
|
4,260 |
|
Computer equipment |
|
|
392 |
|
|
|
387 |
|
Software |
|
|
837 |
|
|
|
797 |
|
Office equipment |
|
|
231 |
|
|
|
142 |
|
Furniture and fixtures |
|
|
816 |
|
|
|
816 |
|
|
|
|
7,265 |
|
|
|
6,804 |
|
Less accumulated depreciation |
|
|
(2,331 |
) |
|
|
(2,041 |
) |
|
|
$ |
4,934 |
|
|
$ |
4,763 |
|
Depreciation expense for the three months ended March 31, 2018 and 2017 was $0.3 million and $0.1 million, respectively.
|
d. |
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
13
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 applicable accounting 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 three months ended March 31, 2018 were as follows (in thousands):
|
|
Breast Products |
|
|
miraDry |
|
|
Total |
|
|||
Balances as of December 31, 2017 |
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
$ |
19,156 |
|
|
$ |
7,629 |
|
|
$ |
26,785 |
|
Accumulated impairment losses |
|
|
(14,278 |
) |
|
|
— |
|
|
|
(14,278 |
) |
Goodwill, net |
|
$ |
4,878 |
|
|
$ |
7,629 |
|
|
$ |
12,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances as of March 31, 2018 |
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
$ |
19,156 |
|
|
$ |
7,629 |
|
|
$ |
26,785 |
|
Accumulated impairment losses |
|
|
(14,278 |
) |
|
|
— |
|
|
|
(14,278 |
) |
Goodwill, net |
|
$ |
4,878 |
|
|
$ |
7,629 |
|
|
$ |
12,507 |
|
The components of the Company’s other intangible assets consist of the following (in thousands):
|
|
Average |
|
|
|
|
||||||||||
|
|
Amortization |
|
|
March 31, 2018 |
|
||||||||||
|
|
Period |
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Intangible |
|
||||
|
|
(in years) |
|
|
Amount |
|
|
Amortization |
|
|
Assets, net |
|
||||
Intangibles with definite lives |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Customer relationships |
|
|
11 |
|
|
$ |
11,240 |
|
|
$ |
(2,266 |
) |
|
$ |
8,974 |
|
Trade names - finite life |
|
|
14 |
|
|
|
5,800 |
|
|
|
(297 |
) |
|
|
5,503 |
|
Developed technology |
|
|
15 |
|
|
|
3,000 |
|
|
|
(156 |
) |
|
|
2,844 |
|
Distributor relationships |
|
|
9 |
|
|
|
500 |
|
|
|
(63 |
) |
|
|
437 |
|
Non-compete agreement |
|
|
2 |
|
|
|
80 |
|
|
|
(65 |
) |
|
|
15 |
|
Regulatory approvals |
|
|
1 |
|
|
|
670 |
|
|
|
(670 |
) |
|
|
- |
|
Acquired FDA non-gel product approval |
|
|
11 |
|
|
|
1,713 |
|
|
|
(1,713 |
) |
|
|
- |
|
Total definite-lived intangible assets |
|
|
|
|
|
$ |
23,003 |
|
|
$ |
(5,230 |
) |
|
$ |
17,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangibles with indefinite lives |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade names - indefinite life |
|
— |
|
|
|
450 |
|
|
|
— |
|
|
|
450 |
|
|
Total indefinite-lived intangible assets |
|
|
|
|
|
$ |
450 |
|
|
$ |
— |
|
|
$ |
450 |
|
14
|
|
|
|
|
|
December 31, 2017 |
|
|||||||||
|
|
Average Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period |
|
|
Gross Carrying |
|
|
Accumulated |
|
|
Intangible |
|
||||
|
|
(in years) |
|
|
Amount |
|
|
Amortization |
|
|
Assets, net |