UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including zip code)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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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.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
As of August 03, 2020, there were
ALPHATEC HOLDINGS, INC.
QUARTERLY REPORT ON FORM 10-Q
June 30, 2020
Table of Contents
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Page |
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Item 1. |
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3 |
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Condensed Consolidated Balance Sheets as of June 30, 2020 (unaudited) and December 31, 2019 |
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4 |
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6 |
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8 |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
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9 |
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Item 2. |
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Management's Discussion and Analysis of Financial Condition and Results of Operations |
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23 |
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Item 3. |
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32 |
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Item 4. |
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32 |
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Item 1. |
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34 |
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Item 1A. |
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34 |
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Item 2. |
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35 |
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Item 5. |
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35 |
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Item 6. |
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36 |
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37 |
2
PART I. FINANCIAL INFORMATION
Item 1. |
Financial Statements |
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except for par value data)
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June 30, 2020 |
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December 31, 2019 |
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Assets |
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(Unaudited) |
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Current assets: |
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Cash |
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$ |
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$ |
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Accounts receivable, net |
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Inventories, net |
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Prepaid expenses and other current assets |
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Withholding tax receivable from Officer |
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— |
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Current assets of discontinued operations |
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Total current assets |
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Property and equipment, net |
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Right-of-use asset |
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Goodwill |
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Intangibles, net |
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Other assets |
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Noncurrent assets of discontinued operations |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Current portion of long-term debt |
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Current portion of operating lease liability |
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Current liabilities of discontinued operations |
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Total current liabilities |
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Long-term debt, less current portion |
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Operating lease liability, less current portion |
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Other long-term liabilities |
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Redeemable preferred stock, $ June 30, 2020 and December 31, 2019; at both June 30, 2020 and December 31, 2019 |
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Commitments and contingencies |
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Stockholders' equity: |
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Series A convertible preferred stock, $ at June 30, 2020 and December 31, 2019; outstanding at June 30, 2020 and December 31, 2019 |
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Series B convertible preferred stock, $ at June 30, 2020 and December 31, 2019; outstanding at June 30, 2020 and December 31, 2019 |
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Common stock, $ outstanding at June 30, 2020, net of |
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Treasury stock, |
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Additional paid-in capital |
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Shareholder note receivable |
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Accumulated other comprehensive income |
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Accumulated deficit |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands, except per share amounts)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenue: |
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Revenue from U.S. products |
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$ |
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$ |
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$ |
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$ |
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Revenue from international supply agreement |
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Total revenue |
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Cost of revenue |
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Gross profit |
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Operating expenses: |
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Research and development |
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Sales, general and administrative |
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Litigation-related |
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Amortization of acquired intangible assets |
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Transaction-related |
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( |
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— |
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— |
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Restructuring |
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— |
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— |
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— |
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Total operating expenses |
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Operating loss |
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( |
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( |
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( |
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Other expense: |
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Interest and other expense, net |
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( |
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( |
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( |
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( |
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Loss on debt extinguishment |
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( |
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— |
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( |
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— |
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Total other expense, net |
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( |
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( |
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( |
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( |
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Loss from continuing operations before taxes |
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( |
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( |
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( |
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Income tax provision |
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Loss from continuing operations |
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( |
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( |
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( |
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( |
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Loss from discontinued operations, net of applicable taxes |
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— |
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( |
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— |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share, basic and diluted: |
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Continuing operations |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Discontinued operations |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
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Shares used in calculating basic and diluted net loss per share |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Foreign currency translation adjustments related to continuing operations |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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See accompanying notes to unaudited condensed consolidated financial statements.
5
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
(In thousands)
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Common stock |
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Series A Convertible Preferred Stock |
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Series B Convertible Preferred Stock |
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Additional paid-in |
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Shareholder note |
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Treasury |
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Accumulated other comprehensive |
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Accumulated |
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Total stockholders’ |
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Shares |
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Par Value |
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Shares |
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Par Value |
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Shares |
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Par Value |
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capital |
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receivable |
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stock |
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income (loss) |
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deficit |
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equity |
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Balance at January 1, 2019 |
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$ |
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$ |
— |
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— |
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$ |
— |
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$ |
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$ |
( |
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$ |
( |
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$ |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Distributor equity incentives |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock issued for conversion of Series A preferred stock |
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— |
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( |
) |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Recognition of beneficial conversion feature - SafeOp Convertible Notes |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock issued for stock option exercises |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock issued for vesting of restricted stock awards, net of shares repurchased for tax liability |
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— |
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— |
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— |
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— |
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— |
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( |
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— |
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— |
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— |
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— |
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( |
) |
Issuance of common stock for acquisition of SafeOp - Milestone 2 |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Foreign currency translation adjustments |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at March 31, 2019 |
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$ |
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— |
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$ |
— |
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— |
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$ |
— |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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$ |
( |
) |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Distributor equity incentives |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock issued for warrant exercises |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock issued for employee stock purchase plan and stock option exercises |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Common stock issued for vesting of restricted stock awards, net of shares repurchased for tax liability |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock warrants |
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— |
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— |
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— |
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— |
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— |
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— |
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|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2019 |
|
|
|
|
|
$ |
|
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
6
|
|
Common stock |
|
|
Series A Convertible Preferred Stock |
|
|
Series B Convertible Preferred Stock |
|
|
Additional paid-in |
|
|
Shareholder note |
|
|
Treasury |
|
|
Accumulated other comprehensive |
|
|
Accumulated |
|
|
Total stockholders’ |
|
|||||||||||||||||||||
|
|
Shares |
|
|
Par Value |
|
|
Shares |
|
|
Par Value |
|
|
Shares |
|
|
Par Value |
|
|
capital |
|
|
receivable |
|
|
stock |
|
|
income (loss) |
|
|
deficit |
|
|
equity |
|
||||||||||||
Balance at January 1, 2020 |
|
|
|
|
|
$ |
|
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
Cumulative effect of change in accounting principle |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Distributor equity incentives |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for warrant exercises |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for employee stock purchase plan and stock option exercises |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for vesting of restricted stock awards, net of shares repurchased for tax liability |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at March 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
Cumulative effect of change in accounting principle |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Distributor equity incentives |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for warrant exercises |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Common stock issued for employee stock purchase plan and stock option exercises |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Common stock issued for vesting of performance and restricted stock awards, net of shares repurchased for tax liability |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Issuance of common stock warrants, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2020 |
|
|
|
|
|
$ |
|
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
7
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
|
|
Six Months Ended June 30, |
|
|||||
|
|
2020 |
|
|
2019 |
|
||
Operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
Amortization of debt discount and debt issuance costs |
|
|
|
|
|
|
|
|
Amortization of right-of-use asset |
|
|
|
|
|
|
|
|
Provision for doubtful accounts |
|
|
|
|
|
|
|
|
Provision for excess and obsolete inventory |
|
|
|
|
|
|
|
|
Deferred income tax benefit |
|
|
— |
|
|
|
|
|
Beneficial conversion feature from convertible notes |
|
|
— |
|
|
|
|
|
Loss on disposal of instruments |
|
|
|
|
|
|
|
|
Accretion to contingent consideration |
|
|
— |
|
|
|
|
|
Loss on extinguishment of debt |
|
|
|
|
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
( |
) |
|
|
|
|
Inventories, net |
|
|
( |
) |
|
|
( |
) |
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
|
|
Other assets |
|
|
— |
|
|
|
|
|
Other long-term assets |
|
|
— |
|
|
|
( |
) |
Accrued expenses and other |
|
|
( |
) |
|
|
|
|
Accounts payable |
|
|
|
|
|
|
|
|
Lease liability |
|
|
( |
) |
|
|
|
|
Other long-term liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
Financing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of common stock, net |
|
|
|
|
|
|
|
|
Borrowings under lines of credit |
|
|
|
|
|
|
|
|
Repayments under lines of credit |
|
|
( |
) |
|
|
( |
) |
Principal payments on capital lease obligations |
|
|
( |
) |
|
|
( |
) |
Proceeds from issuance of term debt, net |
|
|
|
|
|
|
|
|
Principal payments on term loan and notes payable |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
|
|
|
|
|
|
Net decrease in cash |
|
|
( |
) |
|
|
( |
) |
Cash at beginning of period, including discontinued operations |
|
|
|
|
|
|
|
|
Cash at end of period, including discontinued operations |
|
$ |
|
|
|
$ |
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
|
|
|
$ |
|
|
Cash paid for income taxes |
|
$ |
|
|
|
$ |
|
|
Supplemental disclosure of noncash investing and financing activities: |
|
|
|
|
|
|
|
|
Common stock issued for achievement of SafeOp contingent consideration |
|
$ |
— |
|
|
$ |
|
|
Common stock warrants issued with term loan draw |
|
$ |
|
|
|
$ |
|
|
Purchases of property and equipment in accounts payable |
|
$ |
|
|
|
$ |
|
|
See accompanying notes to unaudited condensed consolidated financial statements.
8
ALPHATEC HOLDINGS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. The Company and Basis of Presentation
The Company
Alphatec Holdings, Inc. (the “Company”), through its wholly owned subsidiaries, Alphatec Spine, Inc. (“Alphatec Spine”) and SafeOp Surgical, Inc. (“SafeOp”), designs, develops, and markets technology for the treatment of spinal disorders. The Company markets its products in the U.S. via independent sales agents and a direct sales force.
On March 8, 2018, the Company completed its acquisition of SafeOp, pursuant to a reverse triangular merger of SafeOp into a newly-created wholly-owned subsidiary of the Company, with SafeOp being the surviving corporation and a wholly-owned subsidiary of the Company.
On September 1, 2016, the Company completed the sale of its international distribution operations and agreements (collectively, the “International Business”) to Globus Medical Ireland, Ltd., a subsidiary of Globus Medical, Inc., and its affiliated entities (collectively “Globus”). As a result of this transaction, the International Business has been excluded from continuing operations for all periods presented in this Quarterly Report on Form 10-Q and is reported as discontinued operations. See Note 4 for additional information on the divestiture of the International Business.
Basis of Presentation
The accompanying condensed consolidated balance sheet as of December 31, 2019, which has been derived from audited financial statements, and the unaudited interim condensed consolidated financial statements have been prepared by the Company in accordance with U.S. generally accepted accounting principles (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual audited financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made in this Quarterly Report on Form 10-Q are adequate to make the information not misleading. The unaudited interim condensed consolidated financial statements reflect all adjustments, including normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the financial position and results of operations for the periods presented. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements for the year ended December 31, 2019, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 that was filed with the SEC on March 17, 2020. Operating results for the three and six months ended June 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020, or any other future periods.
Liquidity
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments related to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.
At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date the consolidated financial statements are issued. The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs and comparing those needs to the current cash and cash equivalent balances, and availability under existing credit facilities. The Company’s working capital at June 30, 2020 was $
The Company’s capital requirements over the next twelve months will depend on many factors, including the ability to achieve anticipated revenue, manage operating expense and the timing of required investments in inventory and instrument sets to support its customers. The Company has experienced negative operating cash flows for all historical periods presented and it expects these losses to continue into the foreseeable future, particularly if the COVID-19 pandemic continues to impact operations and surgical volumes. The severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration, extent and severity of the pandemic and its impact on the Company's customers, all of which are uncertain and cannot be predicted.
9
The COVID-19 Pandemic
The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. In late 2019, a novel strain of Coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 has spread globally to all countries, including to the United States. The global spread of the virus has led to unprecedented restrictions on, and disruptions in business and personal activities, which include preventive and precautionary measures that governments, communities, business partners, and the Company have taken and continue to take to manage the impact and mitigate any further spread of the virus. To date, the Company has taken steps to help keep its workforce healthy and safe and is assessing and updating its plans on an ongoing basis, as new information related to the virus and its impact become available.
The Company's future results of operations and liquidity could be adversely impacted by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions and uncertain demand, and the impact of any further initiatives or programs that the Company may undertake to address financial and operations challenges faced by its customers. As of the date of issuance of these condensed consolidated financial statements, the extent to which the pandemic may materially impact the Company's financial condition, liquidity, or results of operations is uncertain. The Company intends to continue to actively monitor the pandemic and take the necessary and required steps to identify and mitigate any adverse impacts on, or risks to, the Company’s business operations posed by the spread of COVID-19.
Reclassification
Certain amounts in the consolidated financial statements for the three and six months ended June 30, 2019 have been reclassified to conform to the current period’s presentation.
2. Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note 2 to its audited consolidated financial statements for the year ended December 31, 2019, which are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 17, 2020. Except as discussed below, these accounting policies have not changed during the three and six months ended June 30, 2020.
Transaction-related (Credits)Expenses
The Company expensed certain costs related to the terminated tender offer for the acquisition of EOS Imaging, which primarily include third-party advisory fees, legal fees and commitment fees related to transaction financing arrangements.
Fair Value Measurements
The carrying amount of financial instruments consisting of cash, restricted cash, trade accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses, accrued compensation and current portion of long-term debt included in the Company’s consolidated financial statements are reasonable estimates of fair value due to their short maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, management believes the fair value of long-term debt approximates its carrying value.
Authoritative guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
|
Level 1: |
Observable inputs such as quoted prices in active markets; |
|
Level 2: |
Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and |
|
Level 3: |
Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
The Company does not maintain any financial assets that are considered to be Level 1, Level 2 or Level 3 instruments as of June 30, 2020. During the second quarter of 2019, the Company issued a liability classified equity award to one of its executive officers. The award will be earned over a
10
The following table provides a reconciliation of liabilities measured at fair value using significant unobservable inputs (Level 3) for the six months ended June 30, 2020 (in thousands):
|
|
Level 3 Liabilities |
|
|
Balance at January 1, 2020 |
|
$ |
|
|
Vested portion of liability classified equity award |
|
|
|
|
Change in fair value measurement |
|
|
( |
) |
Balance at March 31, 2020 |
|
$ |
|
|
Vested portion of liability classified equity award |
|
|
|
|
Change in fair value measurement |
|
|
|
|
Balance at June 30, 2020 |
|
$ |
|
|
Recent Accounting Pronouncements
Recently Adopted Accounting Pronouncements
In November 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-08, Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606), which clarifies that an entity must measure and classify share-based payment awards granted to a customer by applying the guidance in Topic 718. Accounting Standard Codification (“ASC”) 2019-08 is effective for annual reporting periods beginning after December 15, 2019, including interim reporting periods within those annual reporting periods. The Company adopted the guidance effective
In January 2017, the FASB issued ASU 2017-04, Intangibles – Goodwill and Other, which eliminates the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, entities will record an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value. The standard has tiered effective dates, starting in 2020 for calendar-year public business entities that meet the definition of an SEC filer. Early adoption is permitted for annual and interim goodwill impairment testing dates after January 1, 2017. The Company adopted the guidance effective
In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40), which aligns the accounting for cloud computing implementation costs with that of costs to develop or obtain internal-use software, meaning such costs that are part of the application development stage are capitalized as an asset and amortized over the term of the arrangement, otherwise, such costs are expensed as incurred. It also clarifies the classification of amounts related to capitalized implementation costs in the financial statements. ASC 2018-15 is effective for annual reporting periods beginning after December 15, 2019, including interim reporting periods within those annual reporting periods. Early adoption is permitted. The Company adopted the guidance effective
Recently Issued Accounting Pronouncements
The Company has evaluated all recent accounting pronouncements issued by the Financial Accounting Standards Board in the form of Accounting Standards Updates through the date these financial statements were available to be issued and found no recent accounting pronouncements issued, but not yet effective that when adopted, would have a material impact on the financial statements of the Company.
3. Select Condensed Consolidated Balance Sheet Details
Accounts Receivable, net
Accounts receivable, net consist of the following (in thousands):
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
||
Accounts receivable |
|
$ |
|
|
|
$ |
|
|
Allowance for doubtful accounts |
|
|
( |
) |
|
|
( |
) |
Accounts receivable, net |
|
$ |
|
|
|
$ |
|
|
11
Inventories, net
Inventories, net consist of the following (in thousands):
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
||
Raw materials |
|
$ |
|
|
|
$ |
|
|
Work-in-process |
|
|
|
|
|
|
|
|
Finished goods |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less reserve for excess and obsolete finished goods |
|
|
( |
) |
|
|
( |
) |
Inventories, net |
|
$ |
|
|
|
$ |
|
|
Property and Equipment, net
Property and equipment, net consist of the following (in thousands except as indicated):
|
|
Useful lives (in years) |
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
|||
Surgical instruments |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Machinery and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
Computer equipment |
|
|
|
|
|
|
|
|
|
|
|
|
Office furniture and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
Leasehold improvements |
|
|
|
|
|
|
|
|
|
|
|
|
Construction in progress |
|
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less accumulated depreciation and amortization |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Total depreciation expense was $
Intangible Assets, net
|
|
Remaining Avg. Useful lives (in years) |
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
|||
Developed technology |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Intellectual property |
|
|
— |
|
|
|
|
|
|
|
|
|
License agreements |
|
|
|
|
|
|
|
|
|
|
|
|
Trademarks and trade names |
|
|
— |
|
|
|
|
|
|
|
|
|
Customer-related |
|
|
|
|
|
|
|
|
|
|
|
|
Distribution network |
|
|
|
|
|
|
|
|
|
|
|
|
In process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less accumulated amortization |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
Intangible assets, net |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Total amortization expense attributed to intangible assets was $
12
Developed technology and in process research and development intangibles are expected to begin amortizing when the relevant products reach full commercial launch. Future amortization expense related to intangible assets as of June 30, 2020 is as follows (in thousands):
Year Ending December 31, |
|
|
|
|
Remainder of 2020 |
|
|
|
|
2021 |
|
|
|
|
2022 |
|
|
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
Thereafter |
|
|
|
|
|
|
$ |
|
|
Accrued Expenses
Accrued expenses consist of the following (in thousands):
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
||
Commissions and sales milestones |
|
$ |
|
|
|
$ |
|
|
Payroll and payroll related |
|
|
|
|
|
|
|
|
Litigation settlement obligation - short-term portion |
|
|
|
|
|
|
|
|
Professional fees |
|
|
|
|
|
|
|
|
Royalties |
|
|
|
|
|
|
|
|
Interest |
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
Total accrued expenses |
|
$ |
|
|
|
$ |
|
|
Other Long-Term Liabilities
Other long-term liabilities consist of the following (in thousands):
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
||
Litigation settlement obligation - long-term portion |
|
$ |
|
|
|
$ |
|
|
Line of credit exit fee |
|
|
— |
|
|
|
|
|
Tax liabilities |
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
Other long-term liabilities |
|
$ |
|
|
|
$ |
|
|
4. Discontinued Operations
In connection with the sale of the International Business, the Company entered into a product manufacture and supply agreement (the “Supply Agreement”) with Globus, pursuant to which the Company supplies to Globus certain of its implants and instruments (the “Products”), previously offered for sale by the Company in international markets at agreed-upon prices for a minimum term of
13
5. Debt
MidCap Facility Agreement
On May 29, 2020, the Company repaid in full all amounts outstanding under the Amended Credit Facility with MidCap Funding IV, LLC (“MidCap”). The Company made a final payment of $
Squadron Credit Agreement
On November 6, 2018, the Company closed a $
In connection with the financing, the Company issued initial warrants to Squadron to purchase
The Company accounted for the amendments of the Term Loan as debt modifications with continued amortization of the existing and inclusion of the new debt issuance costs amortized into interest expense utilizing the effective interest rate method.
As of June 30, 2020, the debt is recorded at its carrying value of $
Paycheck Protection Loan
On April 23, 2020, the Company received the proceeds from a loan in the amount of approximately $
All or a portion of the PPP Loan may be forgiven by the SBA upon application. Applications for forgiveness of the PPP Loan are currently being accepted by the SBA and may be submitted for up to 16 months after loan approval and upon documentation of expenditures in accordance with the SBA requirements. Under the CARES Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the twenty-four week period, beginning on the date of loan approval. For purposes of the CARES Act, payroll costs exclude compensation of an individual employee in excess of $
14
forgiven is applied to outstanding principal. The Company used all of the proceeds from the PPP Loan to retain employees and maintain payroll. Although it is the intention of the Company, no assurance is provided that the Company will apply for or obtain forgiveness of the PPP Loan in whole or in part. As such, the loan is recorded as long-term debt on the Company’s condensed consolidated balance sheet.
Inventory Financing
The Company has an Inventory Financing Agreement with a key inventory and instrument components supplier whereby the Company may draw up to $
Principal payments remaining on the Company's debt are as follows as of June 30, 2020 (in thousands):
Year Ending December 31, |
|
|
|
|
Remainder of 2020 |
|
$ |
|
|
2021 |
|
|
|
|
2022 |
|
|
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
2025 and thereafter |
|
|
|
|
Total |
|
|
|
|
Add: capital lease principal payments |
|
|
|
|
Less: unamortized debt discount and debt issuance costs |
|
|
( |
) |
Total |
|
|
|
|
Less: current portion of long-term debt |
|
|
( |
) |
Long-term debt, net of current portion |
|
$ |
|
|
Covenants
The Company’s various financing agreements include several event of default provisions, such as payment default, insolvency conditions and a material adverse effect clause, which could cause interest to be charged at a rate which is up to
6. Commitments and Contingencies
Leases
On December 4, 2019, the Company entered into a lease agreement for a new headquarters location which will consist of
Operating Lease
The Company leases its buildings and certain equipment under operating leases which expire on various dates through 2021. Upon the Company’s adoption of ASU 2016-02, Leases (Topic 842), as of January 1, 2019 the Company recognized a ROU asset and lease liability for its building lease, assuming a
15
The Company determines if an arrangement is a lease at inception. The Company has operating leases for its buildings and certain equipment with lease terms of
The Company’s ROU asset represents the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date of the lease or the ASC 842 adoption date, whichever is later, based on the present value of lease payments over the lease term. When readily determinable, the Company uses the implicit rate in determining the present value of lease payments, or 10.5% as of the adoption date. When leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date or adoption date, including the lease term. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
Undiscounted lease payments: |
|
|
|
|
Year Ending December 31, |
|
|
|
|
Remainder of 2020 |
|
$ |
|
|
2021 |
|
|
|
|
2022 |
|
|
|
|
Total undiscounted lease payments |
|
|
|
|
Less: present value adjustment |
|
|
( |
) |
Operating lease liability |
|
|
|
|
Less: current portion of operating lease liability |
|
|
( |
) |
Operating lease liability, less current portion |
|
$ |
|
|
As of June 30, 2020, the Company’s remaining lease term is
Purchase Commitments
The Company entered into a distribution agreement with a third-party provider in January 2020 in which the Company is obligated to certain minimum purchase requirements related to inventory purchases and equipment leases. As of June 30, 2020, the minimum purchase commitment required by the Company under the agreement was $
Litigation
The Company is and may become involved in various legal proceedings arising from its business activities. While management is not aware of any litigation matter that in and of itself would have a material adverse impact on the Company’s consolidated results of operations, cash flows or financial position, litigation is inherently unpredictable, and depending on the nature and timing of a proceeding, an unfavorable resolution could materially affect the Company’s future consolidated results of operations, cash flows or financial position in a particular period. The Company assesses contingencies to determine the degree of probability and range of possible loss for potential accrual or disclosure in the Company’s consolidated financial statements. An estimated loss contingency is accrued in the Company’s consolidated financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Because litigation is inherently unpredictable and unfavorable resolutions could occur, assessing contingencies is highly subjective and requires judgments about future events. When evaluating contingencies, the Company may be unable to provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence of complex or novel legal theories, and/or the ongoing discovery and development of information important to the matters. In addition, damage amounts claimed in litigation against the Company may be unsupported, exaggerated or unrelated to reasonably possible outcomes, and as such are not meaningful indicators of the Company’s potential liability.
16
In February 2018, NuVasive, Inc. filed suit against the Company in the United States District Court for the Southern District of California (NuVasive, Inc. v. Alphatec Holdings, Inc. et al., Case No. 3:18-cv-00347-CAB-MDD (S.D. Cal.)), alleging that certain of the Company’s products (including components of its Battalion™ Lateral System), infringe, or contribute to the infringement of, U.S. Patent Nos. 7,819,801, 8,355,780, 8,439,832, 8,753,270, 9,833,227 (entitled “Surgical access system and related methods”), U.S. Patent No. 8,361,156 (entitled “Systems and methods for spinal fusion”), and U.S. Design Patent Nos. D652,519 (“Dilator”) and D750,252 (“Intervertebral Implant”). NuVasive seeks unspecified monetary damages and an injunction against future purported infringement.
In March 2018, the Company moved to dismiss NuVasive’s claims of infringement of its design patents for failure to state a cognizable legal claim. In May 2018, the Court ruled that NuVasive failed to state a plausible claim for infringement of the asserted design patents and dismissed those claims with prejudice. The Company filed its answer, affirmative defenses and counterclaims to NuVasive’s remaining claims in May 2018.
Also in March 2018, NuVasive moved for a preliminary injunction. In March 2018, the Court denied that motion without prejudice for failure to comply with the Court’s chambers rules. In April 2018, NuVasive again moved for a preliminary injunction. In July 2018, the Court denied that motion on the grounds that NuVasive failed to establish either likelihood of success on the merits of its claims or that it would suffer irreparable harm absent the injunction.
In September 2018, NuVasive filed an Amended Complaint, asserting infringement claims of U.S. Patent Nos. 9,924,859, 9,974,531 and 8,187,334. The Company filed its answer, affirmative defenses and counterclaims to these new claims in October 2018. Also in October 2018, NuVasive moved to dismiss the Company’s counterclaims that NuVasive intentionally had misled the U.S. Patent and Trademark Office as a means of obtaining certain patents asserted against the Company. In January 2019, the Court denied NuVasive’s motion as to all but one of the Company’s counterclaims, but granted the Company leave to amend its counterclaim to cure the dismissal. The Company amended that counterclaim in February 2019 and, that same month, NuVasive again moved to dismiss it. In March 2019, the Court denied NuVasive’s motion. NuVasive filed its Answer to the amended counterclaim in April 2019.
In December 2018, the Company filed a petition with the Patent Trial and Appeal Board (“PTAB”) challenging the validity of certain claims of the ’156 and ’334 Patents. In February 2019, upon joint motion of the parties, the Court stayed all proceedings in this matter, except as noted above, pending PTAB’s determination of whether to institute inter partes review (“IPR”) of the asserted claims of the two patents at issue and vacated the trial date. In July 2019, PTAB instituted IPR of the validity of asserted claims of the two patents at issue and held a hearing on the matter in April 2020. In July 2020, the PTAB ruled that all challenged claims of the ‘156 Patent were valid (not unpatentable) and ruled that several challenged claims of the ‘334 Patent were invalid, while finding that other challenged claims of the ‘334 Patent were valid. The PTAB’s written decision on the matter remains subject to potential motions for reconsideration and/or appeal.
In January 2020, NuVasive filed a Motion for Partial Summary Judgment of infringement and validity of the ’832, ’780 and ’270 Patents and the Company filed a Motion for Summary Judgment of non-infringement of all asserted claims and of invalidity of the ’832 Patent and for dismissal of NuVasive’s claim for lost profits and its allegations of assignor estoppel. In April 2020, the Court granted NuVasive’s Motion as to the alleged infringement of the ’832 Patent only and denied NuVasive’s Motion in all other respects. Also in April 2020, the Court granted the Company’s Motion as to dismissal of the allegations of assignor estoppel and denied the Company’s Motion in all other respects. Trial, which was originally set for April 2020, has been taken off calendar due to increasing uncertainties surrounding the current public health crisis. A new trial date has not been set.
The Company believes that the allegations lack merit and intends to vigorously defend all claims asserted. A liability is recorded in the consolidated financial statements if it is believed to be probable that a loss has been incurred and the amount of the loss can be reasonably estimated. It is impossible at this time to assess whether the outcome of this proceeding will have a material adverse effect on the Company’s consolidated results of operations, cash flows or financial position. Therefore, in accordance with authoritative accounting guidance, the Company has not recorded any accrual for a contingent liability associated with this legal proceeding based on its belief that a liability, while possible, is not probable and any range of potential future charge cannot be reasonably estimated at this time.
Indemnifications
In the normal course of business, the Company enters into agreements under which it occasionally indemnifies third-parties for intellectual property infringement claims or claims arising from breaches of representations or warranties. In addition, from time to time, the Company provides indemnity protection to third-parties for claims relating to past performance arising from undisclosed liabilities, product liabilities, environmental obligations, representations and warranties, and other claims. In these agreements, the scope and amount of remedy, or the period in which claims can be made, may be limited. It is not possible to determine the maximum potential amount of future payments, if any, due under these indemnities due to the conditional nature of the obligations and the unique facts and circumstances involved in each agreement.
17
In October 2017, NuVasive filed a lawsuit in Delaware Chancery Court against Mr. Miles, the Company’s Chairman and CEO, who was a former officer and board member of NuVasive. The Company itself was not initially a named defendant in this lawsuit; however, in June 2018, NuVasive amended its complaint to add the Company as a defendant. As of June 30, 2020, the Company has
Royalties
The Company has entered into various intellectual property agreements requiring the payment of royalties based on the sale of products that utilize such intellectual property. These royalties primarily relate to products sold by Alphatec Spine and are based on fixed fees or calculated either as a percentage of net sales or on a per-unit sold basis. Royalties are included on the accompanying consolidated statements of operations as a component of cost of revenue. As of June 30, 2020, the Company is obligated to pay guaranteed minimum royalty payments under these agreements of approximately $
7. Orthotec Settlement
On September 26, 2014, the Company entered into a Settlement and Release Agreement, dated as of August 13, 2014, by and among the Company and its direct subsidiaries, including Alphatec Spine, Inc., Alphatec Holdings International C.V., Scient'x S.A.S. and Surgiview S.A.S.; HealthpointCapital, LLC, HealthpointCapital Partners, L.P., HealthpointCapital Partners II, L.P., John H. Foster and Mortimer Berkowitz III; and Orthotec, LLC and Patrick Bertranou, (the “Settlement Agreement”). Pursuant to the Settlement Agreement, the Company agreed to pay Orthotec, LLC $
As of June 30, 2020, the Company has made installment payments in the aggregate of $
A reconciliation of the total net settlement obligation is as follows (in thousands):
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
||
Litigation settlement obligation - short-term portion |
|
$ |
|
|
|
$ |
|
|
Litigation settlement obligation - long-term portion |
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
Future Interest |
|
|
|
|
|
|
|
|
Total settlement obligation, gross |
|
|
|
|
|
|
|
|
Related party receivable - included in stockholders' equity |
|
|
( |
) |
|
|
( |
) |
Total settlement obligation, net |
|
$ |
|
|
|
$ |
|
|
18
8. Net Loss Per Share
Basic earnings per share (“EPS”) is calculated by dividing the net income or loss available to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted EPS is computed by dividing the net income available to common stockholders by the weighted average number of common shares outstanding for the period and the weighted average number of dilutive common stock equivalents outstanding for the period determined using the treasury-stock method. For purposes of this calculation, common stock subject to repurchase by the Company, convertible preferred stock, options, convertible notes and warrants are considered to be common stock equivalents and are only included in the calculation of diluted earnings per share when their effect is dilutive.
The following table presents the computation of basic and diluted net loss per share for continuing and discontinued operations (in thousands, except per share amounts):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average unvested common shares subject to repurchase |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Weighted average common shares outstanding—basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted: |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The anti-dilutive securities not included in diluted net loss per share were as follows (in thousands):
|
|
As of June 30, |
|
|||||
|
|
2020 |
|
|
2019 |
|
||
Options to purchase common stock |
|
|
|
|
|
|
|
|
Unvested restricted share awards |
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock |
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
9. Stock Benefit Plans and Equity Transactions
Stock Benefit Plans
On June 17, 2020, the Company’s shareholders approved an amendment to the Company’s 2016 Equity Incentive Award Plan, which increased the shares of Common Stock available for issuance under the Equity Plan by
Salary-to-Equity Conversion Program
Effective April 5, 2020, the Company implemented a voluntary salary-to-equity conversion program for certain employees whose annual payroll costs exceed $
19
Stock-Based Compensation
Total stock-based compensation for the three and six months ended June 30, 2020 and 2019 is as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||
Cost of revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Shares Reserved for Future Issuance
As of June 30, 2020, the Company had reserved shares of its common stock for future issuance as follows (in thousands):
Stock options outstanding |
|
|
|
|
Unvested restricted stock award |
|
|
|
|
Employee stock purchase plan |
|
|
|
|
Series A convertible preferred stock |
|
|
|
|
Warrants outstanding |
|
|
|
|
Authorized for future grant under the Distributor and Development Services plans |
|
|
|
|
Authorized for future grant under the Management Objective Strategic Incentive Plan |
|
|
|
|
Authorized for future grant under the Company equity plans |
|
|
|
|
Total |
|
|
|
|
Warrants Outstanding
2017 PIPE Warrants
The 2017 Common Stock Warrants (the “2017 PIPE Warrants”) have a
2018 PIPE Warrants
The 2018 Common Stock Warrants (the “2018 PIPE Warrants”) have a
Squadron Warrants
As further described in Note 5, during the year ended December 31, 2018, in connection with the initial debt financing with Squadron, the Company issued warrants to purchase
20
interest expense. As the warrants provide for partial price protection that allow for a reduction in the price in the event of a lower per share priced issuance, the warrants were valued utilizing a Monte Carlo simulation that considers the probabilities of future financings. The Monte Carlo model simulates the present value of the potential outcomes of future stock prices of the Company over the seven-year life of the warrants. The projection of stock prices is based on the risk-free rate of return and the volatility of the stock price of the Company and correlates future equity raises based on the probabilities provided.
A summary of all outstanding warrants for common stock is as follows:
|
|
Number of Warrants |
|
|
Strike Price |
|
Expiration |
||
2017 PIPE Warrants* |
|
|
|
|
|
$ |
|
|
|
2018 PIPE Warrants |
|
|
|
|
|
$ |
|
|
|
SafeOp Surgical Merger Warrants |
|
|
|
|
|
$ |
|
|
|
2018 Squadron Capital Warrants |
|
|
|
|
|
$ |
|
|
|
2019 Squadron Capital Warrants |
|
|
|
|
|
$ |
|
|
|
2020 Squadron Capital Warrants |
|
|
|
|
|
$ |
|
|
|
Executive Warrants |
|
|
|
|
|
$ |
|
|
|
Other* |
|
|
|
|
|
$ |
|
|
|
Total |
|
|
|
|
|
|
|
|
|
* |
Represents weighted average exercise price. |
All outstanding warrants were deemed to qualify for equity classification under authoritative accounting guidance.
2017 Distributor Inducement Plan and 2017 Development Services Plan
Under the 2017 Distributor Inducement Plan, the Company is authorized to grant up to
Under the 2017 Development Services Plan, the Company is authorized to grant up to
2019 Management Objective Strategic Incentive Plan
Under the 2019 Management Objective Strategic Incentive Plan, the Company is authorized to grant up to
21
10. Income Taxes
To calculate its interim tax provision, at the end of each interim period the Company estimates the annual effective tax rate and applies that to its ordinary quarterly earnings. In addition, the effect of changes in enacted tax laws or rates or tax status is recognized in the interim period in which the change occurs. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgment including, but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in foreign jurisdictions, permanent and temporary differences between book and tax amounts, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, additional information is obtained or the tax environment changes.
Intraperiod tax allocation rules require the Company to allocate the provision for income taxes between continuing operations and other categories of earnings, such as discontinued operations. In periods in which the Company has a year-to-date pre-tax loss from continuing operations and pre-tax income in other categories of earnings, such as discontinued operations, the Company must allocate the tax provision to the other categories of earnings, and then record a related tax benefit in continuing operations.
The unrecognized tax benefits at June 30, 2020 and December 31, 2019 were $
For the three months ended June 30, 2020, the Company had an effective tax rate of
11. Related Party Transactions
In July 2016, the Company entered into a forbearance agreement with HealthpointCapital, LLC, HealthpointCapital Partners, L.P., and HealthpointCapital Partners II, L.P. (collectively, "HealthpointCapital"), pursuant to which HealthpointCapital, on behalf of the Company, paid $
During the second quarter of 2018, HealthpointCapital Partners, L.P., and HealthpointCapital Partners II, L.P. distributed its holdings in the Company’s common stock to its limited partners. As a result, the fund is no longer a shareholder of the Company as of June 30, 2020. The $
Included on the consolidated balance sheet as of June 30, 2020 is a $
12. Subsequent Event
None.
22
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
You should read the following management's discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and the related notes thereto that appear elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), on March 17, 2020. In addition to historical information the following management’s discussion and analysis of our financial condition and results of operations includes forward-looking information that involves risks, uncertainties, and assumptions. Our actual results and the timing of events could differ materially from those anticipated by these forward-looking statements as a result of many factors, such as those set forth under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and any updates to those risk factors filed from time to time in our subsequent periodic and current reports filed with the SEC.
Overview
We are a medical technology company focused on the design, development, and advancement of technology for better surgical treatment of spinal disorders. We are dedicated to revolutionizing the approach to spine surgery. We have a broad product portfolio designed to address the majority of U.S. market for fusion-based spinal disorder solutions. We intend to drive growth by exploiting our collective spine experience and investing in the research and development to continually differentiate our solutions and improve spine surgery. We believe our future success will be fueled by introducing market-shifting innovation to the spine market, and that we are well-positioned to capitalize on current spine market dynamics.
We market and sell our products in the U.S. through a network of independent distributors and direct sales representatives. An objective of our leadership team is to deliver increasingly consistent, predictable growth. To accomplish this, we have partnered more closely with new and existing distributors to create a more dedicated and loyal sales channel for the future. We have added, and intend to continue to add, new high-quality dedicated distributors to expand future growth. We believe this will allow us to reach an untapped market of surgeons, hospitals, and national accounts across the U.S., as well as better penetrate existing accounts and territories.
We have continued to make progress in the transition of our sales channel since early 2017, driving the percent of sales contributed by our strategic distribution channel from approximately 88% and 86% for the three and six months ended June 30, 2019 to 91% and 90% for the three and six months ended June 30, 2020, respectively. We intend to continue to relentlessly drive toward a fully exclusive network of independent and direct sales agents. Consolidation within the industry is helping facilitate the process, as large, seasoned agents continue to seek opportunities to re-enter the spine market by partnering with spine-focused companies that have broad, growing product portfolios.
Recent Developments
Termination of Tender Offer Agreement and Commitment Letter
On April 27, 2020, we announced the termination of our Tender Offer Agreement with EOS Imaging S.A., or EOS. This decision follows our consideration and analysis of the expected ongoing market effects of the COVID-19 pandemic, including the magnitude and duration of its impact on capital equipment priorities and purchases in significant EOS markets, including the United States. Based upon our assessment, we have concluded that a “Material Adverse Effect” (as defined in the Tender Offer Agreement) has occurred, resulting in circumstances that are no longer conducive to completion of the transaction described in the Tender Offer Agreement. We notified EOS of our termination decision, as required by the Tender Offer Agreement, in a letter dated April 24, 2020.
On April 27, 2020, we also announced that, in connection with the termination of the EOS agreement, we and Perceptive Credit Holdings III, LP have agreed to terminate the debt refinancing commitment letter, including the exclusivity obligations thereunder, entered into in connection with the EOS transaction.
COVID-19 Pandemic
Prior to the spread of COVID-19, we experienced year-over-year U.S. sales growth of over 30%, which was consistent with previously issued revenue guidance in January 2020. As the COVID-19 pandemic spread to Western Europe and the U.S., we experienced a significant decline in procedures from the last half of March 2020 through the month of April. During May procedure volumes began to increase and in the month of June sales and procedure volumes returned to near pre-pandemic levels.
The depth and extent to which the COVID-19 pandemic will impact individual markets continues to vary. We expect procedure volumes to remain difficult to estimate as COVID-19 infections continue to spread and may cause additional strain on hospital resources and deferral of elective procedures.
23
Capital markets and worldwide economies have also been significantly impacted by the COVID-19 pandemic, and it is possible that this could cause a local and/or global economic recession. Such economic recession could have a material adverse effect on our long-term business as hospitals curtail and reduce capital and overall spending. The COVID-19 pandemic and local actions, such as “shelter-in-place” orders and restrictions on our ability to travel and access our customers or temporary closures of the facilities of our suppliers and their contract manufacturers, could further significantly impact our sales and our ability to ship our products and supply our customers. Any of these events could negatively impact the number of procedures performed and have a material adverse effect on our business, financial condition, results of operations, or cash flows.
Revenue and Expense Components
The following is a description of the primary components of our revenue and expenses:
Revenue. We derive our revenue primarily from the sale of spinal surgery implants used in the treatment of spine disorders. Spinal implant products include pedicle screws and complementary implants, interbody devices, plates, and tissue-based materials. Our revenue is generated by our direct sales force and independent distributors. Our products are requested directly by surgeons and shipped and billed to hospitals and surgical centers. Currently, most of our business is conducted with customers within markets in which we have experience and with payment terms that are customary to our business. We may defer revenue until the time of collection if circumstances related to payment terms, regional market risk or customer history indicate that collectability is not certain.
Cost of revenue. Cost of revenue consists of direct product costs, royalties, milestones and the amortization of purchased intangibles. Our product costs consist primarily of direct labor, overhead, and raw materials and components. The product costs of certain of our biologics products include the cost of procuring and processing human tissue. We incur royalties related to the technologies that we license from others and the products that are developed in part by surgeons with whom we collaborate in the product development process. Amortization of purchased intangibles consists of amortization of developed product technology.
Research and development expenses. Research and development expense consists of costs associated with the design, development, testing, and enhancement of our products. Research and development expense also includes salaries and related employee benefits, research-related overhead expenses, fees paid to external service providers in both cash and equity, and costs associated with our Scientific Advisory Board and Executive Surgeon Panels.
Sales, general and administrative expenses. Sales, general and administrative expense consists primarily of salaries and related employee benefits, sales commissions and support costs, depreciation of our surgical instruments, regulatory affairs, quality assurance costs, professional service fees, travel, medical education, trade show and marketing costs, insurance and legal expenses.
Litigation-related expenses. Litigation-related expenses are costs incurred for our ongoing litigation, primarily with NuVasive, Inc.
Transaction-related (credits)expenses. Transaction-related (credits)expenses reflects the recognition of transaction expenses incurred as part of the terminated tender offer related to the EOS transaction.
Restructuring expenses. Restructuring expense consists of severance, social plan benefits and related taxes in connection with our historical cost rationalization efforts.
Loss on debt extinguishment. Loss on debt extinguishment is comprised of all amounts previously recorded as debt issuance costs related to the MidCap facility that was repaid in full.
Other expenses, net. Other expenses, net includes interest income, interest expense, gains and losses from foreign currency exchanges and other non-operating gains and losses.
Income tax benefit. Income tax benefit from continuing operations primarily consists of release of the valuation allowance from the SafeOp acquisition, partially offset by state taxes.
24
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. On an on-going basis, we evaluate our estimates and assumptions, including those related to revenue recognition, allowances for accounts receivable, inventories and intangible assets, stock-based compensation and income taxes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumption conditions.
Critical accounting policies are those that, in management’s view, are most important in the portrayal of our financial condition and results of operations. Aside from the changes disclosed in Note 2 to the Notes to Condensed Consolidated Financial Statements included in Item 1, Part I of this Quarterly Report on Form 10-Q, management believes there have been no material changes during the three months ended June 30, 2020 to the critical accounting policies discussed in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 17, 2020.
Results of Operations
The tables below set forth certain statements of operations data for the periods indicated (in thousands). Our historical results are not necessarily indicative of the operating results that may be expected in the future.
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from U.S. products |
|
$ |
28,834 |
|
|
$ |
26,093 |
|
|
$ |
57,904 |
|
|
$ |
49,048 |
|
Revenue from international supply agreement |
|
|
795 |
|
|
|
1,226 |
|
|
|
1,840 |
|
|
|
2,826 |
|
Total revenue |
|
|
29,629 |
|
|
|
27,319 |
|
|
|
59,744 |
|
|
|
51,874 |
|
Cost of revenue |
|
|
8,787 |
|
|
|
8,433 |
|
|
|
17,871 |
|
|
|
16,420 |
|
Gross profit |
|
|
20,842 |
|
|
|
18,886 |
|
|
|
41,873 |
|
|
|
35,454 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,672 |
|
|
|
3,241 |
|
|
|
7,421 |
|
|
|
6,613 |
|
Sales, general and administrative |
|
|
27,033 |
|
|
|
24,687 |
|
|
|
55,036 |
|
|
|
45,784 |
|
Litigation-related |
|
|
1,304 |
|
|
|
1,200 |
|
|
|
3,947 |
|
|
|
3,823 |
|
Amortization of acquired intangible assets |
|
|
172 |
|
|
|
172 |
|
|
|
344 |
|
|
|
354 |
|
Transaction-related |
|
|
(181 |
) |
|
|
— |
|
|
|
4,091 |
|
|
|
— |
|
Restructuring |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
60 |
|
Total operating expenses |
|
|
32,000 |
|
|
|
29,300 |
|
|
|
70,839 |
|
|
|
56,634 |
|
Operating loss |
|
|
(11,158 |
) |
|
|
(10,414 |
) |
|
|
(28,966 |
) |
|
|
(21,180 |
) |
Other expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense, net |
|
|
(3,032 |
) |
|
|
(1,921 |
) |
|
|
(5,906 |
) |
|
|
(4,040 |
) |
Loss on debt extinguishment |
|
|
(1,555 |
) |
|
|
— |
|
|
|
(1,555 |
) |
|
|
— |
|
Total other expense, net |
|
|
(4,587 |
) |
|
|
(1,921 |
) |
|
|
(7,461 |
) |
|
|
(4,040 |
) |
Loss from continuing operations before taxes |
|
|
(15,745 |
) |
|
|
(12,335 |
) |
|
|
(36,427 |
) |
|
|
(25,220 |
) |
Income tax provision |
|
|
60 |
|
|
|
71 |
|
|
|
100 |
|
|
|
102 |
|
Loss from continuing operations |
|
|
(15,805 |
) |
|
|
(12,406 |
) |
|
|
(36,527 |
) |
|
|
(25,322 |
) |
Loss from discontinued operations, net of applicable taxes |
|
|
— |
|
|
|
(30 |
) |
|
|
— |
|
|
|
(82 |
) |
Net loss |
|
$ |
(15,805 |
) |
|
$ |
(12,436 |
) |
|
$ |
(36,527 |
) |
|
$ |
(25,404 |
) |
25
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||
Revenue by source |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from U.S. products |
|
$ |
28,834 |
|
|
$ |
26,093 |
|
|
$ |
57,904 |
|
|
$ |
49,048 |
|
Revenue from international supply agreement |
|
|
795 |
|
|
|
1,226 |
|
|
|
1,840 |
|
|
|
2,826 |
|
Total revenue |
|
$ |
29,629 |
|
|
$ |
27,319 |
|
|
$ |
59,744 |
|
|
$ |
51,874 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit by source |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from U.S. products |
|
$ |
20,834 |
|
|
$ |
18,841 |
|
|
$ |
41,788 |
|
|
$ |
35,235 |
|
Revenue from international supply agreement |
|
|
8 |
|
|
|
45 |
|
|
|
85 |
|
|
|
219 |
|
Total gross profit |
|
$ |
20,842 |
|
|
$ |
18,886 |
|
|
$ |
41,873 |
|
|
$ |
35,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit margin by source |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from U.S. products |
|
|
72.3 |
% |
|
|
72.2 |
% |
|
|
72.2 |
% |
|
|
71.8 |
% |
Revenue from international supply agreement |
|
|
1.0 |
% |
|
|
3.7 |
% |
|
|
4.6 |
% |
|
|
7.7 |
% |
Total gross profit margin |
|
|
70.3 |
% |
|
|
69.1 |
% |
|
|
70.1 |
% |
|
|
68.3 |
% |
Three and Six Months Ended June 30, 2020 Compared to the Three and Six Months Ended June 30, 2019
Total revenue. Total revenue was $29.6 million for the three months ended June 30, 2020 compared to $27.3 million for the three months ended June 30, 2019, representing an increase of $2.3 million, or 8.4%. Total revenue was $59.7 million for the six months ended June 30, 2020 compared to $51.9 million for the six months ended June 30, 2019, representing an increase of $7.9 million, or 15.0%.
Revenue from U.S. products was $28.8 million for the three months ended June 30, 2020 compared to $26.1 million for the three months ended June 30, 2019, representing an increase of $2.7 million, or 10.3%, and was $57.9 million for the six months ended June 30, 2020 compared to $49.0 million for the six months ended June 30, 2019, representing an increase of $8.9 million, or 18.2%. The increase in revenue for the three and six months ended June 30, 2020 was attributed to the launch of new products and our continued focus on our strategic distribution channel, as detailed below (in thousands):
|
|
Three Months Ended June 30, |
|
|
Increase (Decrease) |
|
|
Six Months Ended June 30, |
|
|
Increase (Decrease) |
|
||||||||||||||||||||||||||||||||||||
|
|
2020 |
|
|
2019 |
|
|
$ |
|
|
% |
|
|
2020 |
|
|
2019 |
|
|
$ |
|
|
% |
|
||||||||||||||||||||||||
U.S. revenue by distributor type: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Strategic distribution |
|
$ |
26,324 |
|
|
|
91 |
% |
|
$ |
22,854 |
|
|
|
88 |
% |
|
$ |
3,470 |
|
|
|
15 |
% |
|
$ |
52,316 |
|
|
|
90 |
% |
|
$ |
42,226 |
|
|
|
86 |
% |
|
$ |
10,090 |
|
|
|
24 |
% |
Legacy and terminated distribution |
|
|
2,510 |
|
|
|
9 |
% |
|
|
3,239 |
|
|
|
12 |
% |
|
|
(729 |
) |
|
|
-23 |
% |
|
|
5,588 |
|
|
|
10 |
% |
|
|
6,822 |
|
|
|
14 |
% |
|
|
(1,234 |
) |
|
|
-18 |
% |
Total U.S. revenue |
|
$ |
28,834 |
|
|
|
100 |
% |
|
$ |
26,093 |
|
|
|
100 |
% |
|
$ |
2,741 |
|
|
|
11 |
% |
|
$ |
57,904 |
|
|
|
100 |
% |
|
$ |
49,048 |
|
|
|
100 |
% |
|
$ |
8,856 |
|
|
|
18 |
% |
Revenue from the international supply agreement which is attributed to sales to Globus under which we supply to Globus certain of its implants and instruments at agreed-upon prices for a minimum term of three years, was $0.8 million for the three months ended June 30, 2020 compared to $1.2 million for the three months ended June 30, 2019, representing a decrease of $0.4 million, and $1.8 million for the six months ended June 30, 2020 compared to $2.8 million for the six months ended June 30, 2019, representing a decrease of $1.0 million. We expect this revenue to continue to decrease over the next several quarters, as Globus continues to register its own products in international markets. Globus has the option to extend the term for up to two additional twelve-month periods subject to Globus meeting specified purchase requirements. During the second quarter of 2020, Globus notified us that it would exercise the option to extend the agreement for the second additional twelve-month period through August 2021.
Cost of revenue. Cost of revenue was $8.8 million for the three months ended June 30, 2020 compared to $8.4 million for the three months ended June 30, 2019, representing an increase of $0.4 million, or 4.8%, and $17.9 million for the six months ended June 30, 2020 compared to $16.4 million for the six months ended June 30, 2019, representing an increase of $1.5 million or 9.1%.
Cost of revenue from U.S. products for the three months ended June 30, 2020 was $8.0 million compared to $7.3 million for the three months ended June 30, 2019, representing an increase of $0.7 million, or 9.6%. The increase is consistent with our revenue growth. Non-cash excess and obsolescence expense primarily related to the phase out of older legacy products was $1.7 million for the three months ended June 30, 2020 compared to $2.2 million for the three months ended June 30,2019, representing a decrease of $0.5 million, or 22.7%, and $3.4 million for the six months ended June 30, 2020 compared to $4.1 million for the six months ended June 30, 2019, representing a decrease of $0.7 million, or 17.1%.
26
Cost of revenue from international supply agreement was $0.8 million for the three months ended June 30, 2020 compared to $1.2 million for the three months ended June 30, 2019, representing a decrease of $0.4 million, or 33.3% ,and $1.8 million for the six months ended June 30, 2020 compared to $2.6 million for the six months ended June 30, 2019, representing a decrease of $0.8 million, or 30.8%. The decrease were attributed to a reduction in sales volumes and related costs under the supply agreement with Globus.
Gross profit. Gross profit was $20.8 million for the three months ended June 30, 2020 compared to $18.9 million for the three months ended June 30, 2019, representing an increase of $1.9 million, or 10.1% and $41.9 million for the six months ended June 30, 2020 compared to $35.5 million for the six months ended June 30, 2019, representing an increase of $6.4 million, or 18.0%.
Gross profit margin from U.S. product revenue increased by 0.1% and 0.4% for the three and six months ended June 30, 2020 as compared to the three and six months ended June 30, 2019, respectively. The changes in gross margin from U.S. product revenue were primarily attributed to a reduction in non-cash excess and obsolescence expense, partially offset by increases in amortization expense related to our SafeOp neuromonitoring system and product mix.
Gross profit margin from international supply agreement decreased by 2.7% and 3.1% for the three and six months ended June 30, 2020 as compared to the three and six months ended June 30, 2019, respectively. The changes in gross margin from international supply agreement were primarily related to the impact of fixed minimum royalty costs, product mix, and to a lesser extent, changes in average selling price for certain products.
Research and development expense. Research and development expense increased $0.5 million, or 15.6% during the three months ended June 30, 2020 compared to the three months ended June 30, 2019 and increased $0.8 million, or 12.1% for the six months ended June 30, 2020. The increase was primarily related to personnel and new project costs, partially offset by decreases in other various research and development initiatives. We expect research and development expenses to increase in future periods as we continue to hire additional engineering and development talent and invest in our product pipeline.
Sales, general and administrative expense. Sales, general and administrative expense increased $2.4 million, or 9.8% during the three months ended June 30, 2020 compared to the three months ended June 30, 2019 and increased $9.2 million, or 20.1% for the six months ended June 30, 2020 compared to the six months ended June 30, 2019. The increase was primarily related to commissions and related sales compensation expenses associated with our increase in U.S. revenue and continued investment in building out our strategic distribution channel, as well as increased marketing efforts, additional headcount and increases in our stock-based compensation. We expect our sales, general and administrative expenses to increase in absolute dollars and in line with expected increase in our U.S. product revenue.
Litigation expenses. Litigation expense increased by $0.1 million, or 8.3% for the three months ended June 30, 2020 as compared to the three months June 30, 2019 and increased by $0.1 million, or 2.6% for the six months ended June 30, 2020 as compared to the six months ended June 30, 2019. The expense is primarily related to our ongoing litigation with NuVasive, Inc. and fluctuations related to the timing of related legal activities.
Amortization of acquired intangible assets. Amortization of acquired intangible assets remained consistent for the three and six months ended June 30, 2020 compared to the three and six months ended June 30, 2019. The expense represents amortization in the period associated with general business assets, intellectual property, licenses and other assets obtained in acquisitions and licensing agreements.
Transaction-related (credits)expenses. Transaction-related (credits)expenses of $-0.2 million and $4.1 million for the three and six months ended June 30, 2020 are attributed to advisory fees, legal fees, transaction financing commitment fees and other transaction-related costs incurred in connection with the terminated EOS tender offer.
Loss on debt extinguishment. As part of the payoff of the MidCap facility in the second quarter of 2020, the remaining balance of all amounts previously recorded as debt issuance costs were recorded as a loss on debt extinguishment.
Interest and other expenses, net. Interest and other expenses, net increased $1.1 million and $1.9 million during the three and six months ended June 30, 2020 as compared to the three and six months ended June 30, 2019, respectively. The increases were primarily due to new debt arrangements and additional draws on existing agreements.
Income tax provision. Income tax provision for the three and six months ended June 30, 2020, was negligible and remained consistent as compared to the three and six months ended June 30, 2019. For the six months ended June 30, 2020, we had an effective income tax rate of 0%, primarily due to our net loss position.
27
Liquidity and Capital Resources
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments related to the recovery of the recorded assets or the classification of the liabilities that might be necessary should we be unable to continue as a going concern.
At each reporting period, we evaluate whether there are conditions or events that raise substantial doubt about our ability to continue as a going concern within twelve months after the date the consolidated financial statements are issued. Our evaluation entails analyzing prospective operating budgets and forecasts for expectations of our cash needs and comparing those needs to the current cash and cash equivalent balances, and availability under existing credit facilities. Our working capital at June 30, 2020 was $53.2 million (including cash of $31.2 million), which along with available draws on an additional $25 million under the credit facility with Squadron Medical Finance Solutions LLC (“Squadron”), allows us to fund operations through at least one year subsequent to the date the financial statements are issued.
Our capital requirements over the next twelve months will depend on many factors, including the ability to achieve anticipated revenue, manage operating expense and the timing of required investments in inventory and instrument sets to support our customers. We have experienced negative operating cash flows for all historical periods presented and we expect these losses to continue into the foreseeable future, particularly if the COVID-19 pandemic continues to impact operations and surgical volumes. The severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration, extent and severity of the pandemic and its impact on our customers, all of which are uncertain and cannot be predicted.
Squadron Credit Agreement, Paycheck Protection Loan and Other Debt and Commitments
On November 6, 2018, we closed a $35 million Term Loan with Squadron, a provider of debt financing to growing companies in the orthopedic industry. The debt bears interest at LIBOR plus 8% (10.0% as of June 30, 2020) per annum. The credit agreement specifies a minimum interest rate of 10% and a maximum of 13% per year. In March 2019, we expanded the credit facility with Squadron for up to an additional $30 million in secured financing. We took a draw of $10.0 million of the expanded credit facility in June 2019 and, subsequently, took a draw of the remaining $20.0 million in April 2020. On May 29, 2020, we entered into a second amendment to the Term Loan to expand the credit facility by an additional $35 million and remove all financial covenant requirements. It is at our sole discretion to make draws on the additional $35 million Term Loan. In June 2020, we took a draw of $10.0 million used to retire the existing working capital revolver with MidCap. All future draws must be made by December 31, 2021. The total principal outstanding under the Term Loan as of June 30, 2020 is $75.0 million with an additional $25 million in available borrowings. Under the terms of the amended facility, the maturity date on the entire term loan was extended to June 2025 with interest-only payments due monthly through November 2022, followed by monthly principal payments of $1.0 million beginning December 2022 and a lump-sum payment payable at maturity in June 2025. As collateral for the Term Loan, Squadron has a first lien security interest in substantially all assets except for accounts receivable.
On April 23, 2020, we received the proceeds from a loan in the amount of approximately $4.3 million (the “PPP Loan”) from Silicon Valley Bank, as lender, pursuant to the Paycheck Protection Program (“PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The PPP Loan matures on April 21, 2022 and bears interest at a rate of 1.0% per annum. Commencing August 21, 2021, we are required to pay the lender equal monthly payments of principal and interest as required to fully amortize by April 21, 2022 the principal amount outstanding on the PPP Loan as of the date prescribed by guidance issued by the SBA. The PPP Loan is evidenced by a promissory note dated April 21, 2020, which contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. We may prepay the PPP Loan at any time prior to maturity with no prepayment penalties.
28
All or a portion of the PPP Loan may be forgiven by the U.S. Small Business Administration (“SBA”) upon application beginning 16 months after loan approval and upon documentation of expenditures in accordance with the SBA requirements. Under the CARES Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the twenty-four-week period beginning on the date of loan approval. For purposes of the CARES Act, payroll costs exclude compensation of an individual employee in excess of $100,000, prorated annually. Not more than 25% of the forgiven amount may be for non-payroll costs. Forgiveness is reduced if full-time headcount declines, or if salaries and wages for employees with salaries of $100,000 or less annually are reduced by more than 25%. In the event the PPP Loan, or any portion thereof, is forgiven pursuant to the PPP, the amount forgiven is applied to outstanding principal. We used all of the proceeds from the PPP Loan to retain employees and maintain payroll. Although it is our intention, no assurance is provided that we will apply for and obtain forgiveness of the PPP Loan in whole or in part.
We entered into an Inventory Financing Agreement whereby we may draw up to $3.0 million for the purchase of inventory to accrue interest at a rate of LIBOR plus 8% and also includes a 10% floor and 13% ceiling. All principal will become due and payable upon maturity on November 6, 2023 and all interest will be paid monthly. Should we elect to prepay the Squadron credit agreement, all amounts due under the Inventory Financing Agreement will become mandatorily due.
As of June 30, 2020, we have made $42.8 million in Orthotec settlement payments and there remains an aggregate amount of $15.0 million in Orthotec settlement payments (including accrued and future interest) to be paid by us.
We entered into a distribution agreement with a third-party provider in January 2020 in which we are obligated to certain minimum purchase requirements related to inventory purchases and equipment leases. As of June 30, 2020, the minimum purchase commitment required by us under the agreement was $3.3 million to be paid over a three-year period.
Our various debt agreements include several event of default provisions, such as payment default, insolvency conditions and a material adverse effect clause, which could cause interest to be charged at a rate which is up to five percentage points above the rate effective immediately before the event of default or result in our lenders’ rights to declare all outstanding obligations immediately due and payable We were in compliance with the covenants under the credit agreements at June 30, 2020.
Operating Activities
We used net cash of $30.1 million from operating activities for the six months ended June 30, 2020. During this period, net cash used in operating activities consisted of our net loss adjusted for $21.3 million of non-cash adjustments including amortization, depreciation, stock-based compensation, provision for doubtful accounts, provision for excess and obsolete inventory, interest expense related to amortization of debt discount and issuance costs, debt extinguishment charges, loss on disposal of instruments, and $14.9 million use of cash related to working capital and other assets.
Investing Activities
We used cash of $7.0 million in investing activities for the six months ended June 30, 2020 primarily for the purchase of surgical instruments to support the commercial launch of new products.
Financing Activities
Financing activities provided $21.1 million of cash for the six months ended June 30, 2020, primarily related to $77.8 million of proceeds from the exercise of stock options or warrants, and borrowings under new and existing lines of credit, partially offset by payments of $56.7 million related to repayments of lines of credit and the extinguishment of an existing debt agreement.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
29
Contractual obligations and commercial commitments
Total contractual obligations and commercial commitments as of June 30, 2020 are summarized in the following table (in thousands):
|
|
Payment Due by Year |
|
|||||||||||||||||||||||||
|
|
Total |
|
|
2020 (remainder) |
|
|
2021 |
|
|
2022 |
|
|
2023 |
|
|
2024 |
|
|
Thereafter |
|
|||||||
Amended Credit Facility with MidCap |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Paycheck Protection Plan Loan |
|
|
4,270 |
|
|
|
— |
|
|
|
2,104 |
|
|
|
2,166 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Inventory financing |
|
|
2,978 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,978 |
|
|
|
— |
|
|
|
— |
|
Squadron Term Loan |
|
|
75,000 |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
|
|
12,000 |
|
|
|
12,000 |
|
|
|
50,000 |
|
Interest expense |
|
|
35,421 |
|
|
|
4,536 |
|
|
|
7,973 |
|
|
|
7,911 |
|
|
|
7,220 |
|
|
|
5,743 |
|
|
|
2,038 |
|
Note payable for software agreements and insurance premiums |
|
|
370 |
|
|
|
370 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Capital lease obligations |
|
|
89 |
|
|
|
15 |
|
|
|
37 |
|
|
|
37 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Facility lease obligations (3) |
|
|
31,792 |
|
|
|
848 |
|
|
|
1,552 |
|
|
|
2,977 |
|
|
|
3,025 |
|
|
|
3,116 |
|
|
|
20,274 |
|
Other purchase commitments and operating lease obligations |
|
|
3,671 |
|
|
|
511 |
|
|
|
2,085 |
|
|
|
1,075 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Litigation settlement obligations, gross (2) |
|
|
15,033 |
|
|
|
2,200 |
|
|
|
4,000 |
|
|
|
4,400 |
|
|
|
4,400 |
|
|
|
33 |
|
|
|
— |
|
Guaranteed minimum royalty obligations |
|
|
4,763 |
|
|
|
335 |
|
|
|
918 |
|
|
|
918 |
|
|
|
918 |
|
|
|
918 |
|
|
|
756 |
|
License agreement milestones (1) |
|
|
2,250 |
|
|
|
— |
|
|
|
700 |
|
|
|
450 |
|
|
|
650 |
|
|
|
250 |
|
|
|
200 |
|
Total |
|
$ |
175,637 |
|
|
$ |
8,815 |
|
|
$ |
19,369 |
|
|
$ |
20,934 |
|
|
$ |
31,191 |
|
|
$ |
22,060 |
|
|
$ |
73,268 |
|
|
(1) |
These commitments represent payments in cash and are subject to attaining certain sales milestones which we believe are reasonably likely to be achieved beginning in 2020. |
|
(2) |
Represents gross payments due to Orthotec, LLC pursuant to a Settlement and Release Agreement, dated as of August 13, 2014, by and among the Company and its direct subsidiaries, including Alphatec Spine, Inc., Alphatec Holdings International C.V., Scient'x S.A.S. and Surgiview S.A.S.; HealthpointCapital, LLC, HealthpointCapital Partners, L.P., HealthpointCapital Partners II, L.P., John H. Foster and Mortimer Berkowitz III; and Orthotec, LLC and Patrick Bertranou. In September 2014, the Company and HealthpointCapital entered into an agreement for joint payment of settlement whereby HealthpointCapital is obligated to pay $5 million of the settlement amount, with payments beginning in the fourth quarter of 2020 and continuing through 2021. See Note 11 to the Notes to Condensed Consolidated Financial Statements included in Item 1, Part I of this Quarterly Report on Form 10-Q for further information. |
|
(3) |
Includes our new headquarters building lease commitment anticipated to commence in November 2020. |
Real Property Leases
In January 2016, we entered into a lease agreement, or the Building Lease, for office, engineering, and research and development space in Carlsbad, California with the lease term through July 31, 2021. Under the Building Lease our monthly rent payable is approximately $105,000 per month during the first year and increases by approximately $3,000 each year thereafter.
On December 4, 2019, we entered into a new lease agreement, or new Building Lease, for a new headquarters location which will consist of 121,541 square feet of office, engineering, and research and development space in Carlsbad, California. The term of the new Building Lease is currently anticipated to commence November 15, 2020 and terminate November 30, 2030, subject to two (2) sixty (60) month options to renew. Base rent under the Building Lease for the first twelve months of the term will be $195,000 per month subject to full abatement during months two through ten. Base rent for the second year of the term will be $244,115 per month and thereafter will increase annually by 3%. At the beginning of each exercised option period, base rent will be adjusted to the market rental value, and thereafter will increase annually by 3% through the end of such option period.
30
Recent Accounting Pronouncements
Aside from newly implemented accounting policies related to leases discussed above under “Critical Accounting Policies and Estimates” and for the changes disclosed in Note 2 to the Notes to Condensed Consolidated Financial Statements (Unaudited) under the heading “Recent Accounting Pronouncements,” there have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended June 30, 2020, as compared to the recent accounting pronouncements described in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, filed on March 17, 2020.
Forward Looking Statements
This Quarterly Report on Form 10-Q incorporates a number of forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including statements regarding:
|
• |
our estimates regarding anticipated operating losses, future revenue, expenses, cost savings, capital requirements, uses and sources of cash and liquidity, including our anticipated revenue growth and cost savings; |
|
• |
our ability to meet the financial covenants under our credit facilities; |
|
• |
our ability to ensure that we have effective disclosure controls and procedures; |
|
• |
our not realizing the full economic benefit from the Globus Transaction, including as a result of indemnification claims under the definitive agreement and the retention by us of certain liabilities associated with the international business, and our ability to meet our obligations under the Globus supply agreement; |
|
• |
our ability to meet, and potential liability from not meeting, the payment obligations under the Orthotec settlement agreement; |
|
• |
our ability to regain and maintain compliance with the quality requirements of the FDA; |
|
• |
our ability to market, improve, grow, commercialize and achieve market acceptance of any of our products or any product candidates that we are developing or may develop in the future; |
|
• |
our beliefs about the features, strengths and benefits of our products; |
|
• |
our ability to successfully achieve and maintain regulatory clearance or approval for our products in applicable jurisdictions and in a timely manner; |
|
• |
the effect of any existing or future federal, state or international regulations on our ability to effectively conduct our business; |
|
• |
our estimates of market sizes and anticipated uses of our products; |
|
• |
our business strategy and our underlying assumptions about market data, demographic trends, reimbursement trends and pricing trends; |
|
• |
our ability to achieve profitability, and the potential need to raise additional funding; |
|
• |
our ability to attract and retain a qualified management team, as well as other qualified personnel and advisors; |
|
• |
our ability to protect our intellectual property, and to not infringe upon the intellectual property of third parties; |
|
• |
our ability to meet or exceed the industry standard in clinical and legal compliance and corporate governance programs; |
|
• |
potential liability resulting from litigation; |
|
• |
potential liability resulting from a governmental review of our business practices; |
|
• |
our beliefs about the usefulness of the non-GAAP financial measures included in this Quarterly Report on Form 10-Q; |
|
• |
our beliefs with respect to our critical accounting policies and the reasonableness of our estimates and assumptions; and |
|
• |
other factors discussed elsewhere in this Quarterly Report on Form 10-Q or any document incorporated by reference herein or therein. |
Any or all of our forward-looking statements in this Quarterly Report on Form 10-Q may turn out to be wrong. They can be affected by inaccurate assumptions and/or by known or unknown risks and uncertainties. Many factors mentioned in our discussion in this Quarterly Report on Form 10-Q will be important in determining future results. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially from expected results.
31
We also provide a cautionary discussion of risks and uncertainties under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and any updates to those risk factors filed from time to time in our subsequent periodic and current reports filed with the SEC. These are factors that we think could cause our actual results to differ materially from expected results. Other factors besides those listed there could also adversely affect us.
Without limiting the foregoing, the words “believe,” “anticipate,” “plan,” “expect,” “estimate,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “continue,” “project,” and similar expressions are intended to identify forward-looking statements. There are a number of factors and uncertainties that could cause actual events or results to differ materially from those indicated by such forward-looking statements, many of which are beyond our control, including the factors set forth under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and any updates to those risk factors filed from time to time in our subsequent periodic and current reports filed with the SEC. In addition, the forward-looking statements contained herein represent our estimate only as of the date of this filing and should not be relied upon as representing our estimate as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking statements.
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
Interest Rate Risk
Other outstanding debt consists of various variable rate instruments, including debt outstanding under the Term Loan with Squadron.
Our borrowings under our credit facilities expose us to market risk related to changes in interest rates. As of June 30, 2020, our outstanding floating rate indebtedness totaled $79.3 million. The primary base interest rate is the LIBOR rate. Assuming the outstanding balance on our floating rate indebtedness remains constant over a year, a 100 basis point increase in the interest rate would decrease pre-tax income and cash flow by approximately $0.8 million.
Commodity Price Risk
We purchase raw materials that are processed from commodities, such as titanium and stainless steel. These purchases expose us to fluctuations in commodity prices. Given the historical volatility of certain commodity prices, this exposure can impact our product costs. However, because our raw material prices comprise a small portion of our cost of revenue, we have not experienced any material impact on our results of operations from changes in commodity prices. A 10% change in commodity prices would not have had a material impact on our results of operations for the three and six months ended June 30, 2020.
Item 4. |
Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in our reports that we file or submit pursuant to the Securities Exchange Act of 1934, as amended, or the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s, or SEC's, rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Under the supervision and with participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we carried out an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based on this evaluation, our Company’s Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable level of assurance.
Previously Reported Material Weaknesses in Internal Control over Financial Reporting
As reported in in our Annual Report on Form 10-K for the year ended December 31, 2019, we identified deficiencies in our internal controls over financial reporting related to our revenue and inventory cycles whereby the review of sales orders and inventory transfers were not properly applied to a portion of orders during the year. We reported these deficiencies to the Audit Committee of our Board of Directors and a material weakness related to these deficiencies existed at December 31, 2019.
32
Remediation of the Material Weakness during the first quarter 2020
The material weakness related to the lack of sufficient review over sales order and inventory transfers resulted in a reasonable possibility that a material misstatement of our revenue and inventory in the annual or interim financial statements may not be prevented or detected on a timely basis. To remediate the deficiencies described above and prevent similar deficiencies in the future, we developed and implemented a remediation plan during the first quarter of 2020 which included:
|
• |
Improving controls to ensure proper documentation over revenue orders and inventory transfers |
|
• |
Assurance that control owners have appropriate training and understanding surrounding affected controls |
Although we have implemented these remediation efforts, the deficiencies will not be considered fully remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. Any actions we have taken or may take to remediate these deficiencies are subject to continued management review supported by testing, as well as oversight by the Audit Committee of our Board of Directors.
We cannot provide complete assurance that other material weaknesses or significant deficiencies will not occur in the future or that we will be able to remediate such weaknesses or deficiencies in a timely manner. The occurrence of such material weaknesses or our inability to remediate these deficiencies could impair our ability to accurately and timely report our financial position, results of operations or cash flows.
Changes in Internal Control over Financial Reporting
Except as described above, there have been no changes to our internal control over financial reporting during the three months ended June 30, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Despite most of our employees working remotely due to the current COVID-19 pandemic, we have not experienced any material impact to our internal control over financial reporting. We will continue to monitor the COVID-19 situation to assess and minimize any impact on the design and operating effectiveness of our internal control over financial reporting.
33
PART II. OTHER INFORMATION
Item 1. |
Legal Proceedings |
Litigation
We are and may become involved in various legal proceedings arising from our business activities. While the Company has no material accruals for pending litigation or claims for which accrual amounts are not disclosed in the Company’s consolidated financial statements, litigation is inherently unpredictable, and depending on the nature and timing of a proceeding, an unfavorable resolution could materially affect our future consolidated results of operations, cash flows or financial position in a particular period. We assess contingencies to determine the degree of probability and range of possible loss for potential accrual or disclosure in our consolidated financial statements. An estimated loss contingency is accrued in our consolidated financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Because litigation is inherently unpredictable and unfavorable resolutions could occur, assessing contingencies is highly subjective and requires judgments about future events. When evaluating contingencies, we may be unable to provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence of complex or novel legal theories, and/or the ongoing discovery and development of information important to the matters. In addition, damage amounts claimed in litigation against us may be unsupported, exaggerated or unrelated to reasonably possible outcomes, and as such are not meaningful indicators of our potential liability.
Refer to Note 6 to the Notes to Condensed Consolidated Financial Statements included in Item 1, Part I of this Quarterly Report on Form 10-Q for further information regarding the NuVasive, Inc. litigation.
Item 1A. |
Risk Factors |
There have been no material changes to the risk factors described under Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 17, 2020 except for those noted below:
COVID-19
In December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 has spread to multiple countries, including the United States, and several European countries. To date, COVID-19 has had, and may continue to have, an adverse impact on our operations, supply chains, distribution channels and expenses as a result of the preventive and precautionary measures that we, our customers, other businesses, and governments are taking, including the deferral of elective medical procedures and diversion of capital and other resources. Due to these impacts and measures, we have experienced and may continue to experience significant and unpredictable reductions in the demand for our products as healthcare customers divert medical resources and priorities towards the treatment of the disease. For example, as COVID-19 reached a global pandemic level in the month of March 2020, we experienced significant decline in procedure volume in the U.S., as healthcare systems diverted resources to meet the increasing demands of managing COVID-19. In addition, the American College of Surgeons, U.S. surgeon general, and other public health bodies have recommended delaying elective surgeries during the COVID-19 pandemic, and surgeons and medical societies are evaluating the risks of minimally invasive surgeries in the presence of infectious diseases, which we expect will continue to negatively impact the usage of our products and procedures performed.
Due to the COVID-19 outbreak, we have experienced significant business disruptions, including restrictions on our ability to sell, distribute and service our products, temporary closures of our facilities and the facilities of our suppliers and their contract manufacturers, as well as reduction in access to our customers due to diverted resources and priorities and the business hours of hospitals as governments institute prolonged shelter-in-place and/or self-quarantine mandates. For example, our corporate headquarters located in California has instituted shelter-in-place orders applicable to our employees in that region. These unprecedented measures to slow the spread of the virus taken by local governments and health care authorities globally, including the deferral of elective medical procedures and social distancing measures, have had, and will continue to have, a significant negative impact on our operations and financial results.
As a result of the shelter-in-place orders implemented by state and local governments, we have instituted a remote work environment which has impacted our employees working at our California headquarters. The remote work environment makes us more susceptible to fraud, system interruptions and similar errors that from time to time result in lost funds or delayed transactions. To date, our email and computer systems have been subject to and are likely to continue to be the target of, fraudulent attacks, including attempts to cause us to improperly transfer funds or defraud our vendors into improperly transferring funds meant for us. These attacks have increased in frequency and sophistication. When a fraud is successfully perpetrated, funds transferred to a fraudulent recipient are often times not recoverable, and, in certain instances, we may be liable for those unrecovered funds. While we have greatly enhanced our automated and manual controls to mitigate this risk, there can be no assurance that such controls will prevent or detect such attempts, which may result in financial losses or other adverse consequences which could be material to us.
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In addition, the COVID-19 pandemic has adversely affected, and may continue to adversely affect, the economies and financial markets of many countries, which may result in a period of regional, national, and global economic slowdown or regional, national, or global recessions that could curtail or delay spending by hospitals and affect demand for our products as well as increased risk of customer defaults or delays in payments. COVID-19 and the current financial, economic, and capital markets environment, and future developments in these and other areas present material uncertainty and risk with respect to our performance, financial condition, volume of business, results of operations, and cash flows. Due to the uncertain scope and duration of the pandemic and uncertain timing of global recovery and economic normalization, we are unable to estimate the impacts on our operations and financial results. As a result, we have withdrawn our full year 2020 financial and procedure guidance.
Our loans under the Paycheck Protection Program may not be forgiven or may subject us to challenges and investigations regarding our qualification for the loan.
On April 23, 2020, we received a loan under the Paycheck Protection Program, also referred to as a “PPP Loan”, which was established under the Coronavirus Aid, Relief and Economic Security Act, known as the CARES Act, in the aggregate principal amount of approximately $4.3 million. Pursuant to section 1106 of the CARES Act, we may apply for and be granted forgiveness for all or a portion of the PPP Loan. Such forgiveness will be determined, subject to limitations, based on the use of the loan proceeds for qualifying expenses, which include payroll costs, rent, and utility costs over the allowable measurements period following the receipt of the loan proceeds.
The SBA continues to develop and issue new and updated guidance regarding the PPP Loan application process, including guidance regarding required borrower certifications and requirements for forgiveness of loans made under the program. We continue to track the guidance as it is released and assess and re-assess various aspects of its application as necessary. However, given the evolving nature of the guidance and our anticipated ability to use the loan proceeds for qualifying expenses, we cannot give any assurance that our PPP loan will be forgiven in whole or in part.
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
None.
Item 5. |
Other Information |
None.
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Item 6. |
Exhibits |
Exhibit |
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Number Exhibit Description |
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4.1 |
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4.2 |
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4.3 |
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4.4 |
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10.1 |
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Second Amendment to Credit, Security and Guaranty Agreement(5) |
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10.2 |
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10.3 |
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Fourth Amendment to the Alphatec Holdings, Inc. 2016 Equity Incentive Plan(7) |
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31.1 |
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31.2 |
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32 |
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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101 |
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The following materials from the Alphatec Holdings, Inc. Quarterly Report on Form 10-Q for the Three and Six Months ended June 30, 2020, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets (Unaudited) as of June 30, 2020 and December 31, 2019, (ii) Condensed Consolidated Statements of Operations (Unaudited) for the Three and Six Months Ended June 30, 2020 and 2019, (iii) Condensed Consolidated Statements of Comprehensive Loss (Unaudited) for the Six Months Ended June 30, 2020 and 2019, (iv) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the Six Months Ended June 30, 2020 and 2019 (v) Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2020 and 2019, and (vi) Notes to Condensed Consolidated Financial Statements (Unaudited). |
104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101.INS) |
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(1) |
Incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on June 4, 2020 |
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(2) |
Incorporated by reference to Exhibit 4.2 to the Company’s Form 8-K filed with the SEC on June 4, 2020 |
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(3) |
Incorporated by reference to Exhibit 4.3 to the Company’s Form 8-K filed with the SEC on June 4, 2020 |
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(4) |
Incorporated by reference to Exhibit 4.4 to the Company’s Form 8-K filed with the SEC on June 4, 2020 |
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(5) |
Incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on June 4, 2020 |
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(6) |
Incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed with the SEC on June 4, 2020 |
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(7) |
Incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on June 18, 2020 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ALPHATEC HOLDINGS, INC. |
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By: |
/s/ Patrick S. Miles |
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Patrick S. Miles |
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Chairman and Chief Executive Officer |
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(principal executive officer) |
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By: |
/s/ Jeffrey G. Black |
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Jeffrey G. Black |
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Executive Vice President and Chief Financial Officer |
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(principal financial officer and principal accounting officer) |
Date: August 6, 2020
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