UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
(Amendment No. 1 to Form 10-Q)
(Mark One)
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x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2015
OR
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o | 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: 000-52024
ALPHATEC HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
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Delaware | | 20-2463898 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
5818 El Camino Real
Carlsbad, CA 92008
(Address of principal executive offices, including zip code)
(760) 431-9286
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer | | o | | Accelerated filer | | x |
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Non-accelerated filer | | o (Do not check if a small reporting company) | | Smaller reporting company | | o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes o No x As of November 2, 2015, there were 101,101,329 shares of the registrant’s common stock outstanding.
EXPLANATORY NOTE
Alphatec Holdings, Inc. (the “Company”) is filing this Amendment No. 1 on Form 10-Q/A (the “Amended Form 10-Q”) to its Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, as originally filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2015 (the “Original Form 10-Q”), to restate its condensed consolidated balance sheet as of September 30, 2015. In connection therewith, the Company hereby amends and replaces in their entirety Items 1, 2 and 4 in Part I, and Item 1A in Part II in the Original Form 10-Q. For the convenience of the reader, this Amended Form 10-Q sets forth the Original Form 10-Q, as modified where necessary to reflect the restatement and revisions.
The Company has determined that it failed to comply with the fixed charge coverage ratio covenant under its amended credit facility (the "Amended Credit Facility") with MidCap Financial, LLC (“MidCap”) for June, August and September of 2015, which constitutes an event of default. In January and February of 2016, MidCap provided waivers of the Company’s failure to comply with the covenant during such periods. The Company can provide no assurance that it will be in compliance with the financial covenants in the future. The Company’s default under the MidCap credit facility also constitutes an event of default under the Company’s facility agreement (the "Facility Agreement") with Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., Deerfield Special Situations Fund, L.P., and Deerfield Special Situations International Master Fund, L.P. (collectively, “Deerfield”), and such default has been waived by Deerfield in February 2016 for the periods above. As a result of these events, the Company has determined that the condensed consolidated balance sheet as of September 30, 2015 that was included in the Original Form 10-Q erroneously classified the outstanding amounts due under the Deerfield Facility Agreement as long-term debt, less current portion, rather than current portion of long-term debt. The condensed consolidated balance sheet as of September 30, 2015 has been restated accordingly to reflect the revised classification of the amounts due under the Deerfield Facility Agreement. This correction also had an effect on the condensed consolidated balance sheet as of June 30, 2015 that was included in the Company's Quarterly Report on Form 10-Q for the Quarter Ended June 30, 2015, as originally filed with the SEC on August 4, 2015. This correction had no effect on the other condensed consolidated financial statements included in the Original Form 10-Q or any other consolidated financial statements previously filed by the Company with the SEC.
As required by Rule 12b-15, the Company’s principal executive officer and principal financial officer are providing new currently dated certifications. Accordingly, the Company hereby amends Item 6 in Part II in the Original Form 10-Q to reflect the filing of the new certifications.
Except as described above, this Amended Form 10-Q does not amend, update or change any other items or disclosures in the Original Form 10-Q and does not purport to reflect any information or events subsequent to the filing thereof. As such, this Amended Form 10-Q speaks only as of the date the Original Form 10-Q was filed, and the Company has not undertaken herein to amend, supplement or update any information contained in the Original Form 10-Q to give effect to any subsequent events. Accordingly, this Amended Form 10-Q should be read in conjunction with the Company’s filings made with the SEC subsequent to the filing of the Original Form 10-Q, including any amendment to those filings.
ALPHATEC HOLDINGS, INC.
QUARTERLY REPORT ON FORM 10-Q/A
September 30, 2015
Table of Contents
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Item 1. | | |
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Item 2. | Management's Discussion and Analysis of Financial Condition and Results of Operations | |
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Item 3. | | |
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Item 4. | | |
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Item 1. | | |
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Item 1A. | | |
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Item 2. | | |
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Item 6. | | |
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PART I. FINANCIAL INFORMATION
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Item 1. | Financial Statements |
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except for par value data)
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| September 30, 2015 | | December 31, 2014 |
Assets | (Restated) | | |
Current assets: | | | |
Cash | $ | 10,502 |
| | $ | 19,735 |
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Restricted cash | 3,450 |
| | 4,400 |
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Accounts receivable, net | 36,252 |
| | 40,440 |
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Inventories, net | 42,328 |
| | 41,747 |
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Prepaid expenses and other current assets | 5,225 |
| | 5,466 |
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Deferred income tax assets | 2,518 |
| | 1,324 |
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Total current assets | 100,275 |
| | 113,112 |
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Property and equipment, net | 23,720 |
| | 26,040 |
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Goodwill | — |
| | 171,333 |
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Intangibles, net | 22,943 |
| | 30,259 |
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Other assets | 1,446 |
| | 4,179 |
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Total assets | $ | 148,384 |
| | $ | 344,923 |
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Liabilities and Stockholders’ (Deficit) Equity | | | |
Current liabilities: | | | |
Accounts payable | $ | 10,827 |
| | $ | 10,130 |
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Accrued expenses | 27,216 |
| | 35,393 |
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Deferred revenue | 831 |
| | 1,300 |
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Common stock warrant liabilities | 687 |
| | 8,702 |
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Current portion of long-term debt | 79,253 |
| | 8,076 |
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Total current liabilities | 118,814 |
| | 63,601 |
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Long-term debt, less current portion | 684 |
| | 74,597 |
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Other long-term liabilities | 29,814 |
| | 32,220 |
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Deferred income tax liabilities | 1,623 |
| | 1,948 |
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Redeemable preferred stock, $0.0001 par value; 20,000 authorized at September 30, 2015 and December 31, 2014; 3,319 shares issued and outstanding at both September 30, 2015 and December 31, 2014 | 23,603 |
| | 23,603 |
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Stockholders’ (deficit) equity: | | | |
Common stock, $0.0001 par value; 200,000 authorized at September 30, 2015 and December 31, 2014; 100,144 and 99,856 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | 10 |
| | 10 |
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Treasury stock, at cost, 19 shares, at both September 30, 2015 and December 31, 2014 | (97 | ) | | (97 | ) |
Additional paid-in capital | 416,620 |
| | 413,921 |
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Shareholder note receivable | (5,000 | ) | | (5,000 | ) |
Accumulated other comprehensive loss | (20,350 | ) | | (11,316 | ) |
Accumulated deficit | (417,337 | ) | | (248,564 | ) |
Total stockholders’ (deficit) equity | (26,154 | ) | | 148,954 |
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Total liabilities and stockholders’ (deficit) equity | $ | 148,384 |
| | $ | 344,923 |
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See accompanying notes to unaudited condensed consolidated financial statements.
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except per share amounts)
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| Three Months Ended | | Nine Months Ended |
| September 30, | | September 30, |
| 2015 | | 2014 | | 2015 | | 2014 |
Revenues | $ | 42,996 |
| | $ | 51,013 |
| | $ | 138,276 |
| | $ | 153,353 |
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Cost of revenues | 14,154 |
| | 14,272 |
| | 48,234 |
| | 46,305 |
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Amortization of acquired intangible assets | 363 |
| | 435 |
| | 1,093 |
| | 1,328 |
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Gross profit | 28,479 |
| | 36,306 |
| | 88,949 |
| | 105,720 |
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Operating expenses: | | | | | | | |
Research and development | 1,898 |
| | 4,423 |
| | 9,661 |
| | 13,138 |
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In-process research and development | 274 |
| | 527 |
| | 274 |
| | 527 |
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Sales and marketing | 17,134 |
| | 18,649 |
| | 51,973 |
| | 56,545 |
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General and administrative | 8,094 |
| | 10,213 |
| | 26,473 |
| | 33,676 |
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Amortization of acquired intangible assets | 521 |
| | 742 |
| | 1,867 |
| | 2,257 |
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Goodwill and intangible impairment | 165,171 |
| | — |
| | 165,171 |
| | — |
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Restructuring expenses | 335 |
| | 20 |
| | 163 |
| | 706 |
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Total operating expenses | 193,427 |
| | 34,574 |
| | 255,582 |
| | 106,849 |
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Operating income (loss) | (164,948 | ) | | 1,732 |
| | (166,633 | ) | | (1,129 | ) |
Other income (expense): | | | | | | | |
Interest income | 18 |
| | 2 |
| | 37 |
| | 8 |
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Interest expense | (3,110 | ) | | (3,875 | ) | | (9,521 | ) | | (9,310 | ) |
Other income (expense), net | 6,058 |
| | (928 | ) | | 6,782 |
| | (1,230 | ) |
Total other income (expense) | 2,966 |
| | (4,801 | ) | | (2,702 | ) | | (10,532 | ) |
Pretax net loss | (161,982 | ) | | (3,069 | ) | | (169,335 | ) | | (11,661 | ) |
Income tax (benefit) provision | (1,717 | ) | | (28 | ) | | (562 | ) | | 948 |
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Net loss | $ | (160,265 | ) | | $ | (3,041 | ) | | $ | (168,773 | ) | | $ | (12,609 | ) |
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Net loss per basic share | $ | (1.61 | ) | | $ | (0.03 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) |
Net loss per diluted share | $ | (1.61 | ) | | $ | (0.04 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) |
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Shares used in calculating basic net loss per share | 99,376 |
| | 97,391 |
| | 99,258 |
| | 97,040 |
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Shares used in calculating diluted net loss per share | 99,376 |
| | 98,329 |
| | 99,258 |
| | 97,258 |
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See accompanying notes to unaudited condensed consolidated financial statements.
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
(in thousands)
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| Three Months Ended | | Nine Months Ended |
| September 30, | | September 30, |
| 2015 | | 2014 | | 2015 | | 2014 |
Net loss | $ | (160,265 | ) | | $ | (3,041 | ) | | $ | (168,773 | ) | | $ | (12,609 | ) |
Foreign currency translation adjustments | 624 |
| | (9,093 | ) | | (9,034 | ) | | (9,815 | ) |
Comprehensive loss | $ | (159,641 | ) | | $ | (12,134 | ) | | $ | (177,807 | ) | | $ | (22,424 | ) |
See accompanying notes to unaudited condensed consolidated financial statements.
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
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| Nine Months Ended September 30, |
| 2015 | | 2014 |
Operating activities: | | | |
Net loss | $ | (168,773 | ) | | $ | (12,609 | ) |
Adjustments to reconcile net loss to net cash provided by (used in) by operating activities: | | | |
Depreciation and amortization | 14,099 |
| | 14,006 |
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Stock-based compensation | 2,440 |
| | 3,641 |
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Interest expense related to amortization of debt discount and debt issuance costs | 3,630 |
| | 4,354 |
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Goodwill and intangible impairment | 165,171 |
| | — |
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Provision for doubtful accounts | 465 |
| | 443 |
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Provision for excess and obsolete inventory | 1,529 |
| | 2,553 |
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Deferred income tax expense | (1,320 | ) | | 338 |
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Non-cash in-process research and development expenses | 98 |
| | 102 |
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Other non-cash items | (4,983 | ) | | 2,655 |
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Changes in operating assets and liabilities: | | | |
Restricted cash | 3,300 |
| | (2,001 | ) |
Accounts receivable | 3,475 |
| | 373 |
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Inventories | (2,202 | ) | | (3,134 | ) |
Prepaid expenses and other current assets | 1,871 |
| | 4,143 |
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Other assets | 15 |
| | (202 | ) |
Accounts payable | (277 | ) | | (261 | ) |
Accrued expenses and other | (12,644 | ) | | (34,684 | ) |
Deferred revenues | (328 | ) | | (1 | ) |
Net cash provided by (used in) operating activities | 5,566 |
| | (20,284 | ) |
Investing activities: | | | |
Purchases of property and equipment | (8,738 | ) | | (7,751 | ) |
Cash received from sale of assets | — |
| | 300 |
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Net cash used in investing activities | (8,738 | ) | | (7,451 | ) |
Financing activities: | | | |
Borrowings under lines of credit | 105,523 |
| | 122,066 |
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Repayments under lines of credit | (110,354 | ) | | (115,068 | ) |
Principal payments on capital lease obligations | (555 | ) | | (605 | ) |
Proceeds from notes payable | 5,000 |
| | 24,500 |
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Principal payments on notes payable | (6,163 | ) | | (3,836 | ) |
Net cash (used in) provided by financing activities | (6,549 | ) | | 27,057 |
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Effect of exchange rate changes on cash | 488 |
| | (498 | ) |
Net decrease in cash | (9,233 | ) | | (1,176 | ) |
Cash at beginning of period | 19,735 |
| | 21,345 |
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Cash at end of period | $ | 10,502 |
| | $ | 20,169 |
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See accompanying notes to unaudited condensed consolidated financial statements.
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS—(Continued)
(UNAUDITED)
(in thousands)
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| Nine Months Ended September 30, |
| 2015 | | 2014 |
Supplemental disclosure of cash flow information: |
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Cash paid for interest | $ | 5,677 |
| | $ | 4,074 |
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Cash paid for income taxes | $ | 580 |
| | $ | 487 |
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Purchases of property and equipment in accounts payable | $ | 2,458 |
| | $ | 2,217 |
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Non-cash debt discount | $ | — |
| | $ | 500 |
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Initial fair value of warrant liability | $ | — |
| | $ | 10,368 |
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Purchase of property and equipment through capital lease | $ | 243 |
| | $ | 759 |
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See accompanying notes to unaudited condensed consolidated financial statements.
ALPHATEC HOLDINGS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. The Company and Basis of Presentation
The Company
Alphatec Holdings, Inc., through its wholly owned subsidiary, Alphatec Spine, Inc. and its subsidiaries (“Alphatec Spine”), designs, develops, manufactures and markets products for the surgical treatment of spine disorders. In addition to its U.S. operations, the Company also markets its products in over 50 international markets through the distribution channels of Alphatec Spine and its affiliate, Scient’x S.A.S., and its subsidiaries (“Scient’x”), via a direct sales force in Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa. In South America and Latin America, the Company conducts its operations through its Brazilian subsidiary, Cibramed Productos Medicos. In Japan, the Company markets its products through its subsidiary, Alphatec Pacific, Inc. and its subsidiaries (“Alphatec Pacific”).
Basis of Presentation
The accompanying condensed consolidated balance sheet as of December 31, 2014, 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 interim unaudited 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 financial statements for the year ended December 31, 2014, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 that was filed with the SEC on February 26, 2015.
Operating results for the three and nine months ended September 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015, or any other future periods.
The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through revenues from the sale of its products, equity financings and debt financings. As the Company has incurred losses, successful transition to profitability is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. This may not occur and, unless and until it does, the Company will continue to need to raise additional capital. The accompanying Condensed Consolidated Financial Statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. A going concern basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of its liabilities in the normal course of business. Operating losses and negative cash flows may continue for at least the next year as the Company continues to incur costs related to the execution of its operating plan, introduction of new products and expansion into new geographies. The Company's amended and restated credit facility (the "Amended Credit Facility") with MidCap Financial, LLC ("MidCap") matures in August 2016, which will require the Company to refinance the Amended Credit Facility with MidCap or to seek alternative financing. Management intends to pursue additional opportunities to raise additional capital through public or private equity offerings, debt financings, receivables financings or collaborations or partnerships with other companies to further support its planned operations. However, there is no assurance that it will be able to do so.
Restatement of Condensed Consolidated Financial Statements
The Company has determined that it failed to comply with the fixed charge coverage ratio covenant under its Amended Credit Facility with MidCap for June, August and September of 2015. The Company’s default under the MidCap credit facility also constitutes an event of default under the Facility Agreement with Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., Deerfield Special Situations Fund, L.P., and Deerfield Special Situations International Master Fund, L.P., (collectively "Deerfield"). In January and February of 2016, MidCap and Deerfield provided a waiver of the Company’s failure to comply with the covenant during such periods. The Company can provide no assurance that it will be in compliance with the financial covenants in the future. As a result of these events of default, the Company has determined to
restate the condensed consolidated balance sheet as of September 30, 2015 to classify the amounts due under the Deerfield Facility Agreement as current portion of long-term debt, rather than long-term debt, less current portion.
As a result of this error correction, the current portion of the long-term debt increased from $59.0 million as previously reported to $79.3 million and the amount of long-term debt less current portion decreased from$20.9 million as previously reported to $0.7 million. This correction had no effect on the other condensed consolidated financial statements included in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 that was filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2015.
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, 2014, which are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on February 26, 2015. Except as discussed below, these accounting policies have not significantly changed during the nine months ended September 30, 2015.
Goodwill
The Company accounts for goodwill in accordance with authoritative guidance which requires that goodwill be tested for impairment at least annually. The Company tests goodwill for impairment as of December 31 of each year, or more frequently if events and circumstances warrant. These assets are impaired if the Company determines that their carrying values may not be recoverable based on an assessment of certain events or changes in circumstances. If the assets are considered to be impaired, the Company recognizes the amount by which the carrying value of the assets exceeds the fair value of the assets as an impairment loss. In the third quarter of 2015, the market value of the Company’s common stock substantially declined. As a result of this decline, the Company determined that it had an indicator of impairment of its goodwill, and an interim test of goodwill impairment was required. As a result, the Company reviewed its goodwill for impairment under a two-part test in accordance with authoritative guidance.
The Company estimated the fair value in step one of the goodwill impairment test based on a combination of the income approach which included discounted cash flows as well as a market approach that utilized the guideline company market information. The fair value measurements utilized to perform the impairment analysis are categorized within Level 3 of the fair value hierarchy. The Company’s discounted cash flows required management judgment with respect to forecasted sales, launch of new products, gross margin, selling, general and administrative expenses, capital expenditures and the selection and use of an appropriate discount rate and terminal rate. For purposes of calculating the discounted cash flows, the Company used estimated revenue growth rates between 3% and 13% for the discrete forecast period. Cash flows beyond the discrete forecast period were estimated using a terminal value calculation, which incorporated historical and forecasted financial trends and considered long-term earnings growth rates for publicly traded peer companies. Future cash flows were then discounted to present value at a discount rate of 13.5%, and terminal value growth rate of 3%. The Company's market capitalization was also considered in assessing the reasonableness of the Company’s fair value as determined in step one of the goodwill impairment test. The Company’s assessment resulted in a fair value that was lower than the Company’s carrying value of net assets at September 30, 2015.
Based upon step one of the test, the Company determined that its goodwill was impaired and that step two of the test was required to measure the amount of goodwill impairment. As a result of step two, in the third quarter of 2015 the Company recorded a charge of $164.3 million, representing the write-off of the remaining balance of goodwill. Due to the length of time necessary to measure impairment of goodwill, the goodwill impairment analysis was not completed as of the time of the filing of this Quarterly Report on Form 10-Q and is subject to change. The Company expects to complete the step two impairment analysis prior to reporting its financial results for the fourth quarter of 2015 and will record any adjustments to this preliminary estimate at that time.
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:
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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 instruments that are considered to be Level 1 or Level 2 instruments as of September 30, 2015 or December 31, 2014. The Company classifies its common stock warrant liabilities within Level 3 of the fair value hierarchy because they are valued using valuation models with significant unobservable inputs. The following table provides a reconciliation of liabilities measured at fair value using significant unobservable inputs (Level 3) for the nine months ended September 30, 2015 (in thousands):
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| Common Stock Warrant Liabilities |
Balance at December 31, 2014 | $ | 8,702 |
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Changes in fair value | (8,015 | ) |
Balance at September 30, 2015 | $ | 687 |
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Common stock warrant liabilities are measured at fair value using the Black-Scholes option pricing valuation model. The assumptions used in the Black-Scholes option pricing valuation model for the common stock warrant liabilities were: (a) a risk-free interest rate based on the rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the remaining contractual term of the warrants; (b) an assumed dividend yield of zero based on the Company’s expectation that it will not pay dividends in the foreseeable future; (c) an expected term based on the remaining contractual term of the warrants; and (d) an expected volatility based upon the Company's historical volatility over the remaining contractual term of the warrants. The significant unobservable input used in measuring the fair value of the common stock warrant liabilities associated with the Deerfield Facility Agreement (described in Note 5 below) is the expected volatility. Significant increases in volatility would result in a higher fair value measurement.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board ("FASB") issued new accounting guidance related to revenue recognition. This new standard will replace all current U.S. GAAP guidance on this topic and eliminate all industry-specific guidance. The new revenue recognition standard provides a unified model to determine when and how revenue is recognized. The core principle is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. On August 12, 2015, the FASB issued guidance deferring the effective date by one year to December 15, 2017 for annual reporting periods beginning after that date. The FASB also permitted early adoption of the standard, but not before the original effective date of December 15, 2016. The Company is currently evaluating the impact, if any, the adoption of this standard will have on its financial statements.
In August 2014, the FASB issued guidance related to disclosures of uncertainties about an entity’s ability to continue as a going concern. The guidance requires management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued. Management will be required to make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. Substantial doubt exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. The guidance is effective for annual periods ending after December 15, 2016 and for interim reporting periods within annual periods beginning after December 15, 2016, with early adoption permitted. The Company is currently evaluating the impact of this guidance and expects to adopt the standard for the annual reporting period ending December 31, 2016.
In April 2015, the FASB issued guidance that amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. The guidance will not change the amortization of debt issuance costs, which will continue to follow the existing accounting guidance. The guidance is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. The Company is currently evaluating the impact of adopting this new accounting standard on its financial statements.
3. Select Balance Sheet Details
Accounts Receivable, net
Accounts receivable, net consist of the following (in thousands):
|
| | | | | | | |
| September 30, 2015 | | December 31, 2014 |
Accounts receivable | $ | 37,298 |
| | $ | 41,233 |
|
Allowance for doubtful accounts | (1,046 | ) | | (793 | ) |
Accounts receivable, net | $ | 36,252 |
| | $ | 40,440 |
|
Inventories, net
Inventories, net consist of the following (in thousands)
|
| | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2015 | | December 31, 2014 |
| Gross | | Reserve for excess and obsolete | | Net | | Gross | | Reserve for excess and obsolete | | Net |
Raw materials | $ | 6,449 |
| | $ | — |
| | $ | 6,449 |
| | $ | 5,020 |
| | $ | — |
| | $ | 5,020 |
|
Work-in-process | 1,898 |
| | — |
| | 1,898 |
| | 1,032 |
| | — |
| | 1,032 |
|
Finished goods | 53,930 |
| | (19,949 | ) | | 33,981 |
| | 57,020 |
| | (21,325 | ) | | 35,695 |
|
Inventories | $ | 62,277 |
| | $ | (19,949 | ) | | $ | 42,328 |
| | $ | 63,072 |
| | $ | (21,325 | ) | | $ | 41,747 |
|
Property and Equipment, net
Property and equipment, net consist of the following (in thousands except as indicated): |
| | | | | | | | | |
| Useful lives (in years) | | September 30, 2015 | | December 31, 2014 |
Surgical instruments | 4 | | $ | 64,838 |
| | $ | 62,872 |
|
Machinery and equipment | 7 | | 15,585 |
| | 15,382 |
|
Computer equipment | 3 | | 3,700 |
| | 3,180 |
|
Office furniture and equipment | 5 | | 3,752 |
| | 3,789 |
|
Leasehold improvements | various | | 3,854 |
| | 3,841 |
|
Building | 39 | | 66 |
| | 65 |
|
Land | n/a | | 9 |
| | 9 |
|
Construction in progress | n/a | | 468 |
| | 1,320 |
|
| | | 92,272 |
| | 90,458 |
|
Less accumulated depreciation and amortization | | | (68,552 | ) | | (64,418 | ) |
Property and equipment, net | | | $ | 23,720 |
| | $ | 26,040 |
|
Total depreciation expense was $3.4 million and $2.9 million for the three months ended September 30, 2015 and 2014, respectively. Total depreciation expense was $9.1 million and $9.2 million for the nine months ended September 30, 2015 and 2014, respectively. At September 30, 2015, assets recorded under capital leases of $3.2 million were included in the machinery and equipment balance and $0.2 million were included in the construction in progress balance. At December 31, 2014, assets recorded under capital leases of $3.2 million were included in the machinery and equipment balance and $0.6 million were included in the construction in progress balance. Amortization of assets under capital leases was included in depreciation expense.
Intangible Assets, net
Intangible assets, net consist of the following (in thousands except for useful lives):
|
| | | | | | | | | |
| Useful lives (in years) | | September 30, 2015 | | December 31, 2014 |
Developed product technology | 3-8 | | $ | 21,825 |
| | $ | 22,526 |
|
Distribution rights | 3 | | 2,100 |
| | 2,095 |
|
Intellectual property | 5 | | 1,004 |
| | 1,004 |
|
License agreements | 1-7 | | 16,716 |
| | 16,716 |
|
Core technology | 10 | | 4,187 |
| | 4,554 |
|
Trademarks and trade names | 3-9 | | 3,307 |
| | 3,559 |
|
Customer-related | 12-15 | | 19,458 |
| | 20,493 |
|
Distribution network | 10-12 | | 4,027 |
| | 4,027 |
|
Physician education programs | 10 | | 2,575 |
| | 2,802 |
|
Supply agreement | 10 | | 225 |
| | 225 |
|
| | | 75,424 |
| | 78,001 |
|
Less accumulated amortization | | | (52,481 | ) | | (47,742 | ) |
Intangible assets, net | | | $ | 22,943 |
| | $ | 30,259 |
|
Total amortization expense was $1.1 million and $1.6 million for the three months ended September 30, 2015 and 2014, respectively. Total amortization expense was $5.0 million and $4.8 million for the nine months ended September 30, 2015 and 2014, respectively.
On June 19, 2015, the Company entered into an exclusive distribution agreement with a third party to market a biologic product that would replace its existing NEXoss Synthetic Bone Graft (See Note 4). The Company expensed $0.3 million as an impairment charge in cost of goods sold in the nine months ended September 30, 2015 for the write-off of an intangible asset related to this product. Additionally, due to a revised marketing strategy for the Company's Epicage interbody fusion device, the Company evaluated the related intangible asset for impairment in June 2015. As a result of this impairment analysis the Company expensed $0.9 million as an impairment charge in cost of goods sold in the nine months ended September 30, 2015 for the write-off of an intangible asset related to this product.
In connection with the step two goodwill impairment test (see Note 2) the Company determined that the physician education intangible acquired in the Scient’x acquisition was impaired. As a result, the Company expensed $0.9 million included in goodwill and intangible impairment in the three and nine months ended September 30, 2015. Prior to the impairment, amortization of the physician education intangible asset had been recorded in amortization of acquired intangible assets within operating expenses.
Future amortization expense related to intangible assets as of September 30, 2015 is as follows (in thousands): |
| | | |
Year Ending December 31, | |
Remainder of 2015 | $ | 1,036 |
|
2016 | 4,059 |
|
2017 | 4,053 |
|
2018 | 2,884 |
|
2019 | 2,441 |
|
Thereafter | 8,470 |
|
| $ | 22,943 |
|
Accrued Expenses
Accrued expenses consist of the following (in thousands):
|
| | | | | | | |
| September 30, 2015 | | December 31, 2014 |
Legal | $ | 554 |
| | $ | 967 |
|
Accounting | 1,017 |
| | 1,262 |
|
Severance | 322 |
| | 318 |
|
Restructuring | 137 |
| | 531 |
|
Sales milestones | 133 |
| | 107 |
|
Accrued taxes | 729 |
| | 1,344 |
|
Deferred rent | 462 |
| | 785 |
|
Royalties | 1,712 |
| | 2,129 |
|
Commissions | 5,189 |
| | 6,152 |
|
Payroll and related | 5,359 |
| | 8,291 |
|
Litigation settlements | 4,400 |
| | 7,393 |
|
Accrued interest | 1,017 |
| | 946 |
|
Other | 6,185 |
| | 5,168 |
|
Total accrued expenses | $ | 27,216 |
| | $ | 35,393 |
|
Goodwill
The changes in the carrying amount of goodwill from December 31, 2014 through September 30, 2015 are as follows (in thousands):
|
| | | |
| |
Balance at December 31, 2014 | $ | 171,333 |
|
Goodwill impairment | (164,266 | ) |
Effect of foreign exchange rate on goodwill | (7,067 | ) |
Balance at September 30, 2015 | $ | — |
|
In the third quarter of 2015, the market value of the Company’s common stock substantially declined. As a result of this decline, the Company determined that it had an indicator of impairment of its goodwill, and an interim test of goodwill impairment was required (See Note 2). As a result of this interim test, the Company recorded a charge of $164.3 million, representing the write-off of the balance of goodwill in the three and nine months ended September 30, 2015. Due to the length of time necessary to measure impairment of goodwill, the goodwill impairment analysis was not completed as of the time of the filing of this Quarterly Report on Form 10-Q and is subject to change. The Company expects to complete the step two impairment analysis prior to reporting its financial results for the fourth quarter of 2015 and will record any adjustments to this preliminary estimate at that time.
4. License and Consulting Agreements
The Company’s license and consulting agreements are described below and in Note 5 to its audited consolidated financial statements for the year ended December 31, 2014, which are included in its Annual Report on Form 10-K which was filed with the SEC on February 26, 2015.
License Agreements
In June 2015 the Company entered into an exclusive distribution agreement with a third party supplier pursuant to which the Company acquired exclusive worldwide distribution rights to market a synthetic biologic product under the Company's own brand name (the "Biologic Supply Agreement"). The Biologic Supply Agreement requires the Company to make minimum payments to the third party supplier for the Company's worldwide distribution rights under the agreement to remain exclusive.
Asset Purchase Agreement
In July 2014, the Company entered into an asset purchase and product development services agreement (the "Asset Purchase Agreement") whereby the Company purchased rights to the conceptual design for an intervertebral implant device. The financial terms of the Agreement include payments in cash and the Company's common stock upon achievement of various milestones. The Company treated this arrangement as an asset acquisition. In the three months ended September 30, 2014, the Company made cash payments totaling $0.2 million and issued 72,992 shares of the Company's common stock valued at $0.1 million. The Company recognized the cash and stock payments of $0.3 million as in-process research and development expense in the three and nine months ended September 30, 2014.
Under the terms of the Asset Purchase Agreement, for milestones achieved in September 2015, the Company was obligated to pay $0.2 million cash compensation and issue 72,992 shares of the Company's common stocks valued at $0.1 million. The Company expensed $0.3 million as in-process research and development in the three and nine months ended September 30, 2015.
5. Debt
MidCap Facility Agreement
On August 30, 2013, the Company entered into the Amended Credit Facility with MidCap. The Amended Credit Facility amended and restated the prior credit facility that the Company had with MidCap (the "Prior Credit Facility"). Pursuant to the Amended Credit Facility, the Company increased the borrowing limit from $50 million to $73 million. The Company also extended the maturity of the credit facility to August 2016. In July 2015, the Company further amended the Amended Credit Facility to provide for an additional term loan of $5 million. As of September 30, 2015, the Amended Credit Facility consisted of a $38 million term loan, $28 million of which was drawn at closing and the remaining $5 million of which was drawn in April 2014, a $5 million term loan drawn in July 2015 and a revolving line of credit with a maximum borrowing base of $40 million, of which $27.0 million was outstanding under the revolving line of credit at September 30, 2015. The Company used the term loan proceeds of $28 million drawn at closing to repay a portion of the outstanding balance on the prior revolving line of credit.
The term loan interest rate is priced at the London Interbank Offered Rate ("LIBOR") plus 8.0%, subject to a 9.5% floor, and the revolving line of credit interest rate remains priced at LIBOR plus 6.0%, reset monthly. At September 30, 2015, the revolving line of credit carried an interest rate of 6.2% and the term loan carries an interest rate of 9.5%. The borrowing base is determined, from time to time, based on the value of domestic eligible accounts receivable and domestic eligible inventory. As collateral for the Amended Credit Facility, the Company granted MidCap a security interest in substantially all of its assets, including all accounts receivable and all securities evidencing its interests in its subsidiaries. In addition to monthly payments of interest, monthly repayments of $0.5 million are due through maturity, with the remaining principal due upon maturity.
In connection with the execution of the Amended Credit Facility, the Company incurred an additional $0.4 million in costs that were capitalized as debt issuance costs. At September 30, 2015, $0.3 million remains as unamortized debt issuance costs related to the prior and Amended Credit Facility within the unaudited consolidated balance sheet, which will be amortized over the remaining term of the Amended Credit Facility.
The Amended Credit Facility includes traditional lending and reporting covenants including a fixed charge coverage ratio, a senior leverage ratio and a total leverage ratio to be maintained by the Company. The Amended Credit Facility also includes several event of default provisions, such as payment default and insolvency conditions, 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 MidCap’s right to declare all outstanding obligations immediately due and payable.
In February 2013, the Company and MidCap entered into a first amendment to the Credit Facility (the "First Amendment to the Credit Facility”). The First Amendment to the Credit Facility allowed the Company to exclude payments related to an acquisition and a settlement agreement from calculation of the fixed charge coverage ratio and the senior leverage ratio. In conjunction with the First Amendment to the Credit Facility, the Company paid MidCap a fee of $0.1 million.
On March 17, 2014, the Company entered into a first amendment to the Amended Credit Facility with MidCap (the "First Amendment to the Amended Credit Facility"). Under the First Amendment to the Amended Credit Facility, MidCap gave the Company its consent to enter into the Facility Agreement (defined below) and make settlement payments in connection with the Orthotec litigation. The First Amendment to the Amended Credit Facility also added a total leverage ratio financial covenant.
On July 10, 2015, the Company entered into a Second Amendment to the Amended Credit Facility with MidCap (the "Second Amendment to the Amended Credit Facility") to increase the term loan commitment from $33 million to $38 million. The Company borrowed the additional $5 million under the term loan on July 10, 2015, which is the third term loan tranche under the Amended Credit Facility (the "Third Term Loan Tranche"). Until January 1, 2016, only interest payments are due for the Third Term Loan Tranche. Thereafter, the Company will pay an amount equal to $0.5 million on the first day of each calendar month as an amortization payment in respect of all tranches of the term loan. The Company paid MidCap, a commitment fee equal to 1.0% of the principal amount of the funds disbursed in the Third Term Loan Tranche.
The Company was in compliance with all of the covenants of the Amended Credit Facility as of September 30, 2015, except for the non-compliance disclosed in Note 1. The Company has obtained waivers in January and February of 2016 from MidCap to cure the breach of the fixed charge coverage ratio covenant for each of June, August and September of 2015. There is not assurance that the Company will be in compliance with the financial covenants of the Amended Credit Facility in the future.
Deerfield Facility Agreement
On March 17, 2014, the Company entered into the facility agreement with Deerfield (the "Facility Agreement"), pursuant to which Deerfield agreed to loan the Company up to $50 million, subject to the terms and conditions set forth in the Facility Agreement. Under the terms of the Facility Agreement, the Company had the option, but was not required, upon certain conditions to draw the entire amount available under the Facility Agreement, at any time until January 30, 2015 (the “Draw Period”), provided that the initial draw be used for a portion of the payments made in connection with the Orthotec settlement described in Note 7 below. The Company agreed to pay Deerfield, upon each disbursement of funds under the Facility Agreement, a transaction fee equal to 2.5% of the principal amount of the funds disbursed. Amounts borrowed under the Facility Agreement bear interest at a rate of 8.75% per annum and are payable on the third, fourth and fifth anniversary date of the first amount borrowed under the Facility Agreement, with the final payment due on March 20, 2019.
The Facility Agreement also contains various representations and warranties, and affirmative and negative covenants, customary for financings of this type, including restrictions on the ability of the Company and its subsidiaries to incur additional indebtedness or liens on its assets, except as permitted under the Facility Agreement. As security for the Company's repayment of its obligations under the Facility Agreement, the Company granted to Deerfield a security interest in substantially all of the Company's property and interests in property, which is subordinated to the security interest granted under the Amended Credit Facility.
In connection with the execution of the Facility Agreement on March 17, 2014, the Company issued to Deerfield warrants to purchase an aggregate of 6,250,000 shares of the Company’s common stock, which are immediately exercisable and have an exercise price equal to $1.39 per share (the “Initial Warrants”). Additionally, the Company agreed that each disbursement borrowing under the Facility Agreement be accompanied by the issuance to Deerfield of warrants to purchase up to 10,000,000 shares of the Company’s common stock, in proportion to the amount of draw compared to the total $50 million facility (the "Draw Warrants").
On March 20, 2014, the Company made an initial draw of $20 million under the Facility Agreement and received net proceeds of $19.5 million to fund the portion of the settlement payment obligations that were due in 2014 to Orthotec, LLC. The $0.5 million transaction fee is recorded as a debt discount and is being amortized over the term of the draw, which ends March 20, 2019. In connection with this borrowing, the Company issued Draw Warrants to purchase 4,000,000 shares of common stock at an exercise price of $1.39 per share, which were valued at $4.7 million and recorded as a debt discount, which is being amortized over the term of the $20 million draw. Additionally, $2.3 million of the value of the Initial Warrants was reclassified as a debt discount and is being amortized through interest expense over the term of the debt using the effective interest method.
On November 21, 2014, the Company made a second draw of $6.0 million under the Facility Agreement and received net proceeds of $5.9 million to fund a portion of the Orthotec settlement payments due through 2016. The $0.2 million transaction fee was recorded as a debt discount and is being amortized over the remaining term of the draw, which ends March 20, 2019. In connection with this second draw, the Company issued Draw Warrants to purchase 1,200,000 shares of common stock at an exercise price of $1.39 per share, which were valued at $0.9 million and were recorded as a debt discount, which is being amortized over the term of the debt using the effective interest method. Additionally, $0.2 million of the value of the Initial Warrants was reclassified as a debt discount and is being amortized through interest expense over the term of the debt using the effective interest method. No amounts remain available for the Company to borrow under the Facility Agreement.
As of September 30, 2015, Orthotec settlement payments of $21.9 million have been made, leaving remaining proceeds from the funds borrowed under the Facility Agreement of $3.5 million, which was classified as short-term restricted cash, as its use is limited under the terms of the Facility Agreement for the payments of amounts due under the Orthotec litigation settlement agreement. Additionally, a payment of $1.1 million was made on October 1, 2015. The amounts borrowed under the
Facility Agreement, which total $26.0 million in principal as of September 30, 2015, are due in three equal annual payments beginning March 20, 2017. As a result of the Company's non-compliance with the MidCap fixed charge coverage ratio covenant, the Company was in cross-default of the Facility Agreement, for which the Company received a waiver from Deerfield in February 2016 for the months of June, August and September 2015. There is no assurance that the Company will be in compliance with the financial covenants of the Amended Credit Facility in the foreseeable future, which would result in cross-default under the Facility Agreement in which case Deerfield would have the right to call the debt outstanding under the Facility Agreement due immediately. Accordingly, as disclosed in Note 1, the amounts borrowed under the Facility Agreement are presented on the condensed consolidated balance sheet as of September 30, 2015 under current liabilities, net of unamortized issuance discount.
As of September 30, 2015, the outstanding Initial Warrants and Draw Warrants to purchase an aggregate of 11,450,000 shares of common stock were revalued to their fair value with a charge to other income expense of $6.3 million and $8.0 million for the three months and nine months ended September 30, 2015, respectively. The change in the fair value of the warrants of $8.0 million for the nine months ended September 30, 2015 is included in other non-cash items in the condensed consolidated statements of cash flow. The warrant liability of $0.7 million is recorded as common stock warrant liabilities within current liabilities on the condensed consolidated balance sheet as of September 30, 2015.
On July 10, 2015, the Company entered into a First Amendment to the Facility Agreement (the “Facility Agreement First Amendment”), with Deerfield. The Facility Agreement First Amendment permitted, among other things, the Company to enter into and borrow the additional $5 million under the term loan in July 2015 under the Second Amendment to the Amended Credit Facility.
At September 30, 2015, the outstanding warrants were valued using the Black-Scholes option pricing model. This is a Level 3 measurement using the following assumptions:
|
| | |
| September 30, 2015 |
Risk-free interest rate | 1.3 | % |
Dividend yield | — | % |
Expected volatility | 63 | % |
Expected life (years) | 4.5 |
|
Principal payments on debt are as follows as of September 30, 2015 (in thousands):
|
| | | |
| |
Year Ending December 31, | |
Remainder of 2015 (1) | $ | 2,058 |
|
2016 (1) | 56,173 |
|
2017 (1) | 8,667 |
|
2018 (1) | 8,667 |
|
2019 (1) | 8,666 |
|
Thereafter | — |
|
Total | 84,231 |
|
Add: capital lease principal payments | 1,471 |
|
Less: debt discount | (5,765 | ) |
Total | 79,937 |
|
Less: current portion of long-term debt (1) | (79,253 | ) |
Long-term debt, net of current portion | $ | 684 |
|
(1) The amounts above are presented based on the contractual payment schedules in each of the respective agreements. However, the debt balance under the Amended Credit Facility and the Facility Agreement was callable as of September 30, 2015 due to the event of default (See Note 1 and Note 5) and therefore, is presented as a current liability on the condensed consolidated balance sheet as of September 30, 2015.
6. Commitments and Contingencies
Leases
The Company leases certain equipment under capital leases which expire on various dates through September 2018. The leases bear interest at rates ranging from 6.6% to 9.6% per annum, are generally due in monthly principal and interest installments and are collateralized by the related equipment. The Company also leases its buildings and certain equipment and vehicles under operating leases which expire on various dates through January 2019. Future minimum annual lease payments under such leases are as follows as of September 30, 2015 (in thousands):
|
| | | | | | | |
Year Ending December 31, | Operating | | Capital |
Remainder of 2015 | $ | 899 |
| | $ | 224 |
|
2016 | 2,318 |
| | 877 |
|
2017 | 846 |
| | 437 |
|
2018 | 272 |
| | 68 |
|
2019 | 137 |
| | — |
|
| $ | 4,472 |
| | 1,606 |
|
Less: amount representing interest | | | (135 | ) |
Present value of minimum lease payments | | | 1,471 |
|
Current portion of capital leases | | | (799 | ) |
Capital leases, less current portion | | | $ | 672 |
|
Rent expense under operating leases for the three months ended September 30, 2015 and 2014 was $0.8 million. Rent expense under operating leases for the nine months ended September 30, 2015 and 2014 was $2.3 million and $2.6 million, respectively.
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 our 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.
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 calculated either as a percentage of net sales or in one instance on a per-unit sold basis. Royalties are included on the accompanying condensed consolidated statement of operations as a component of cost of revenues.
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 $49 million in cash, including initial cash payments totaling $1.75 million, which the Company previously paid in March 2014, and an additional lump sum payment of $15.75 million, which the Company previously paid in April 2014. The Company agreed to pay the remaining $31.5 million in 28 quarterly installments of $1.1 million and then one additional quarterly installment of $0.7 million, commencing October 1, 2014. As of September 30, 2015, the Company has made installment payments in the aggregate of $21.9 million. The Company has the right to prepay the amounts due without penalty. In addition, the unpaid balance of the amounts due accrues interest at the rate of 7% per year beginning May 15, 2014 until the amounts due are paid in full. The accrued but unpaid interest will be paid in quarterly installments of $1.1 million (or the full amount of the accrued but unpaid interest if less than $1.1 million) following the full payment of the $31.5 million in quarterly installments described above. No interest will accrue on the accrued interest. The Settlement Agreement provided for mutual releases of all claims in the Orthotec, LLC v. Surgiview, S.A.S, et al. matter in the Superior Court of California, Los Angeles County and all other related litigation matters involving the Company and its directors and affiliates.
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, options 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 (in thousands, except per share data):
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2015 | | 2014 | | 2015 | | 2014 |
Numerator: | | | | | | | |
Net loss for basic earnings per share | $ | (160,265 | ) | | $ | (3,041 | ) | | $ | (168,773 | ) | | $ | (12,609 | ) |
Decrease in fair value of warrants | — |
| | (513 | ) | | — |
| | (520 | ) |
Diluted net loss applicable to common stockholders | $ | (160,265 | ) | | $ | (3,554 | ) | | $ | (168,773 | ) | | $ | (13,129 | ) |
Denominator: | | | | | | | |
Weighted average common shares outstanding | 100,144 |
| | 98,126 |
| | 100,092 |
| | 97,864 |
|
Weighted average unvested common shares subject to repurchase | (768 | ) | | (735 | ) | | (834 | ) | | (824 | ) |
Weighted average common shares outstanding—basic | 99,376 |
| | 97,391 |
| | 99,258 |
| | 97,040 |
|
Effect of dilutive securities: | | | | | | | |
Conversion of preferred stock | — |
| | — |
| | — |
| | — |
|
Options | — |
| | — |
| | — |
| | — |
|
Warrants | — |
| | 938 |
| | — |
| | 218 |
|
Weighted average common shares outstanding—diluted | 99,376 |
| | 98,329 |
| | 99,258 |
| | 97,258 |
|
Net loss per share: | | | | | | | |
Basic | $ | (1.61 | ) | | $ | (0.03 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) |
Diluted | $ | (1.61 | ) | | $ | (0.04 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) |
The anti-dilutive securities not included in diluted net loss per share were as follows (in thousands):
|
| | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2015 | | 2014 | | 2015 | | 2014 |
Options to purchase common stock | 7,859 |
| | 6,904 |
| | 8,029 |
| | 7,199 |
|
Unvested restricted share awards | 768 |
| | 735 |
| | 834 |
| | 824 |
|
Warrants to purchase common stock | 11,544 |
| | 594 |
| | 11,544 |
| | 6,844 |
|
Total | 20,171 |
| | 8,233 |
| | 20,407 |
| | 14,867 |
|
9. Stock Benefit Plans and Stock-Based Compensation
In February 2015, the Company granted 1,854,000 performance-based restricted stock units ("PSUs") to certain employees under its 2005 Employee, Director and Consultant Stock Plan (the "2005 Plan"). The PSUs vest based upon the Company's achievement of certain performance goals over the period from January 1, 2015 through December 31, 2017. The number of PSUs that may vest varies between 0%-200% based on the achievement of such goals. The PSUs were valued at $1.35 per share based on the closing price of the Company's common stock on the date of grant. For purposes of measuring compensation expense, the amount of PSUs ultimately expected to vest is estimated at each reporting date based on management’s expectations regarding the relevant performance criteria. The recognition of compensation expense associated with PSUs requires judgment in assessing the probability of meeting the performance goals, as well as defined criteria for assessing achievement of the performance-related goals. The awards are deemed probable of vesting as of September 30, 2015.
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 as the tax environment changes.
The Company recognizes interest and penalties related to uncertain tax positions as a component of the income tax provision. The Company’s unrecognized tax benefits decreased less than $0.2 million during the nine months ended September 30, 2015. The decrease in unrecognized tax benefits during the nine months ended September 30, 2015 was primarily related to foreign currency fluctuations and changes in prior year uncertain tax positions within the Company's foreign subsidiaries, partially offset by an increase related to state research credits and uncertain tax positions within the Company’s foreign subsidiaries. The unrecognized tax benefits at September 30, 2015 and December 31, 2014 were $8.7 million and $8.9 million, respectively. With the facts and circumstances currently available to the Company, it is reasonably possible that the amount that could reverse over the next 12 months is insignificant. Additionally, the French restructuring (see Note 12) may result in limitations on the Company’s ability to utilize its French net operating loss carryforwards to offset future taxable income.
The income tax benefit consists primarily of the income tax benefit related to the reversal of the deferred tax liabilities associated with tax deductible goodwill, partially offset by income tax provisions related to state income taxes and operations in other foreign jurisdictions where the Company operates. The tax impact of the $165.2 million impairment charge (see note 2) in the current quarter is a $1.5 million income tax benefit as a result of the reversal of the deferred tax liabilities on the tax deductible goodwill due to the Company having a valuation allowance against deferred tax assets.
The Company is not currently under examination by the Internal Revenue Service, or by any foreign, state or local tax authorities.
11. Segment and Geographical Information
Operating segments are defined as components of an enterprise for which separate financial information is available and evaluated regularly by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company has one operating and one reportable business segment.
During the three and nine months ended September 30, 2015 and 2014, the Company operated in two geographic regions, the U.S. and International, which consists of locations outside of the U.S. In the International geographic region, sales in Japan for the three and nine months ended September 30, 2015 totaled $8.3 million and $23.7 million, respectively, which represented greater than 10 percent of the Company’s consolidated revenues for such periods. In the International geographic region, sales in Japan for the three and nine months ended September 30, 2014 totaled $8.5 million and $23.8 million, respectively, which represented greater than 10 percent of the Company’s consolidated revenues for such periods.
Revenues attributed to the geographic location of the customer were as follows (in thousands):
|
| | | | | | | | | | | | | | | |
| Three Months Ended | | Nine Months Ended |
| September 30, | | September 30, |
| 2015 | | 2014 | | 2015 | | 2014 |
United States | $ | 27,385 |
| | $ | 34,808 |
| | $ | 85,099 |
| | $ | 101,376 |
|
International | 15,611 |
| | 16,205 |
| | 53,177 |
| | 51,977 |
|
Total consolidated revenues | $ | 42,996 |
| | $ | 51,013 |
| | $ | 138,276 |
| | $ | 153,353 |
|
Total assets by region were as follows (in thousands):
|
| | | | | | | |
| September 30, 2015 | | December 31, 2014 |
United States | $ | 99,710 |
| | $ | 200,978 |
|
International | 48,674 |
| | 143,945 |
|
Total consolidated assets | $ | 148,384 |
| | $ | 344,923 |
|
12. Restructuring
On September 16, 2013, the Company announced that Scient'x began a process to significantly restructure its business operations in France in an effort to improve operating efficiencies and rationalize its cost structure. The restructuring included a reduction in Scient'x's workforce and closing of the manufacturing facilities in France. The Company has recorded total costs of $10.3 million to date associated with this restructuring, which includes employee severance, social plan benefits and related taxes, facility closing costs, manufacturing transfer costs, and contract termination costs, in accordance with ASC Topic 420, Accounting for Costs Associated with Exit or Disposal Activities, and ASC Topic 712, Non Retirement Postemployment Benefits. The Company has substantially completed the activities associated with the Scient'x restructuring as of September 30, 2015, and substantially all of the costs have been paid.
On July 6, 2015, the Company announced a restructuring of its manufacturing operations in California in an effort to improve its cost structure. The restructuring includes a reduction in workforce and closing the California manufacturing facility. Restructuring liabilities are measured at fair value and recognized as incurred. The restructuring will take place over the next year and the Company estimates that it will incur termination benefits, accelerated depreciation, facility closing and other restructuring costs of up to $4 million.
Certain restructuring costs are based upon estimates. Actual amounts paid may ultimately be different from these estimates. If additional costs are incurred, such additional costs will be recognized when they occur.
13. Related Party Transactions
For the nine months ended September 30, 2015 and 2014, the Company incurred expenses of $0.1 million related to HealthpointCapital, LLC. As of September 30, 2015, the Company also had a liability of $0.1 million payable to HealthpointCapital, LLC for travel and administrative expenses.
The Company has entered into indemnification agreements with certain of its directors which are named defendants in the New York Orthotec matter (see Note 7 – Orthotec Settlement). The indemnification agreements require the Company to indemnify these individuals to the fullest extent permitted by applicable law and to advance expenses incurred by them in connection with any proceeding against them to which they may be entitled to indemnification by the Company. For the nine months ended September 30, 2015 and 2014, the Company incurred legal expenses of zero and less than $0.1 million, respectively, in connection with the Company’s indemnification obligations for two former directors of Scient'x in the New York Orthotec matter.
14. Subsequent Event
On November 2, 2015, the Company entered into a first amendment (the "First Amendment") to the collaboration agreement with Elite Medical Holdings, LLC and Pac 3 Surgical Products, LLC (the "Collaborators") (the "Collaboration Agreement"). Under the Collaboration Agreement, the Collaborators agreed to provide services related to the development and commercialization of the Company’s current products and products in the Company’s product pipeline. As consideration for the services, the Collaboration Agreement provides that the Company will issue an aggregate $8.0 million of the Company’s common stock, based on a per share price of $1.95 per share, which was the average of the closing price of the Company’s common stock on The NASDAQ Global Select Market on each of the four days prior to the effective date and the effective of the Collaboration Agreement. Pursuant to the First Amendment, in exchange for a "lock up" restriction on selling or transferring each tranche of shares issued to the Collaborators and a maximum value cap (as discussed below), the Company has agreed to make a cash payment to the Collaborators in the event that the shares in such tranche do not have a minimum amount of value based on the market value of the Company’s common stock at the end of the lock up period applicable to such tranche of shares. In addition, in the event that at the end of a lock up period the value of a tranche of shares issued to the Collaborators exceeds a certain amount, the Collaborators have agreed to forfeit shares back to the Company, so as to limit the maximum amount of value derived from such shares at the end of a lock up period. Pursuant to the First Amendment, the shares issued to the Collaborators in each of 2014, 2015 and 2016 are subject to a lock up that lasts until the first quarter of 2017, 2018 and 2019, respectively. The valuation of each tranche of shares occurs at the end of the applicable lock up period. Based on the closing price of the Company’s common stock on October 30, 2015, the Company could have an additional liability of $3.5 million for shares of the Company’s common stock previously issued under the Collaboration Agreement, with $2.1 million payable in 2017 and $1.4 million million payable in 2018. In addition, based on the closing price of the Company’s common stock on October 30, 2015, the Company could have an additional liability of $2.8 million for shares of the Company’s common stock issuable under the remaining terms of the Collaboration Agreement (assuming that all of the shares issuable under the Collaboration Agreement are issued), with $0.7 million payable in 2018 (in addition to the amount above payable in 2018), and $2.1 million payable in 2019. If the Collaborators elect to sell, assign or transfer: (i) more than 20% of the shares issued to the Collaborators prior to the first valuation date; or (ii) any of the Collaborator shares still subject to a lockup after the first valuation date, all of the aforementioned restrictions on transfer and valuation minimums and maximums are null and void. Other than as set forth in the First Amendment, the Collaboration Agreement remains in full force and effect.
|
| |
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, or SEC, on February 26, 2015. 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 in our Annual Report on Form 10-K for the year ended December 31, 2014 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, manufacturing and marketing of products for the surgical treatment of spine disorders. We have a comprehensive product portfolio and pipeline that addresses the cervical, thoracolumbar and intervertebral regions of the spine and covers a variety of major spinal disorders and surgical procedures. Our principal product offerings are focused on the global market for orthopedic spinal disorder solutions. We believe that our products and systems have enhanced features and benefits that make them attractive to surgeons and that our broad portfolio of products and systems provide a comprehensive solution for the safe and successful surgical treatment of spinal disorders.
Revenue and Expense Components
The following is a description of the primary components of our revenues and expenses:
Revenues. We derive our revenues primarily from the sale of spinal surgery implants used in the treatment of spine disorders. Spinal implant products include spine screws and complementary products, vertebral body replacement devices, plates, products to treat vertebral compression fractures and bone grafting materials. Our revenues are 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. In general, except for those countries where we have a direct sales force (the U.S., Japan, Italy and the United Kingdom), we use independent distributors that purchase our products and market them to surgeons. A majority of our business is conducted with customers within markets in which we have experience and with payment terms that are customary to our business. If we offer payment terms greater than our customary business terms or begin operating in a new market, revenues are deferred until the earlier of when payments become due or cash is received from the related distributors.
Cost of revenues. Cost of revenues consists of direct product costs, royalties, milestones, depreciation of our surgical instruments, and the impairment and the amortization of purchased intangibles. We manufacture substantially all of the non-tissue-based implants that we sell. Our product costs consist primarily of direct labor, manufacturing 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 expense. 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, and costs associated with our Scientific Advisory Board and Executive Surgeon Panels.
In-process research and development expense. In-process research and development expense consists of acquired research and development assets that were not part of an acquisition of a business and were not technically feasible on the date we acquired such technology, provided that technology did not have any alternative future use at that date.
Sales and marketing expense. Sales and marketing expense consists primarily of salaries and related employee benefits, sales commissions and support costs, professional service fees, travel, medical education, trade show and marketing costs.
General and administrative expense. General and administrative expense consists primarily of salaries and related employee benefits, professional service fees and legal expenses.
Goodwill and intangible impairment. Goodwill and intangible impairment consists of the expensing the premium paid over fair value for businesses acquired in prior periods and the impairment of intangible assets.
Restructuring expense. Restructuring expense consists of severance, social plan benefits and related taxes, facility closing costs, manufacturing transfer costs and contract termination incurred in connection with the reorganization of the Scient’x operations in France and our manufacturing operations in California.
Total other income (expense). Total other income (expense) includes interest income, interest expense, gains and losses from foreign currency exchanges, gains and losses on warrant liability and other non-operating gains and losses.
Income tax (benefit) provision . Income tax (benefit) provision consists primarily of state and foreign income taxes and the tax effect of changes in deferred tax liabilities associated with tax goodwill.
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, goodwill 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. Except for 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 nine months ended September 30, 2015 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, 2014 filed with the SEC on February 26, 2015.
Results of Operations
The table below sets 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 | | Nine Months Ended |
| September 30, | | September 30, |
| 2015 | | 2014 | | 2015 | | 2014 |
Revenues | $ | 42,996 |
| | $ | 51,013 |
| | $ | 138,276 |
| | $ | 153,353 |
|
Cost of revenues | 14,154 |
| | 14,272 |
| | 48,234 |
| | 46,305 |
|
Amortization of acquired intangible assets | 363 |
| | 435 |
| | 1,093 |
| | 1,328 |
|
Gross profit | 28,479 |
| | 36,306 |
| | 88,949 |
| | 105,720 |
|
Operating expenses: | | | | | | | |
Research and development | 1,898 |
| | 4,423 |
| | 9,661 |
| | 13,138 |
|
In-process research and development | 274 |
| | 527 |
| | 274 |
| | 527 |
|
Sales and marketing | 17,134 |
| | 18,649 |
| | 51,973 |
| | 56,545 |
|
General and administrative | 8,094 |
| | 10,213 |
| | 26,473 |
| | 33,676 |
|
Amortization of acquired intangible assets | 521 |
| | 742 |
| | 1,867 |
| | 2,257 |
|
Goodwill and intangible impairment | 165,171 |
| | — |
| | 165,171 |
| | — |
|
Restructuring expense | 335 |
| | 20 |
| | 163 |
| | 706 |
|
Total operating expenses | 193,427 |
| | 34,574 |
| | 255,582 |
| | 106,849 |
|
Operating income (loss) | (164,948 | ) | | 1,732 |
| | (166,633 | ) | | (1,129 | ) |
Other income (expense): | | | | | | | |
Interest income | 18 |
| | 2 |
| | 37 |
| | 8 |
|
Interest expense | (3,110 | ) | | (3,875 | ) | | (9,521 | ) | | (9,310 | ) |
Other income (expense), net | 6,058 |
| | (928 | ) | | 6,782 |
| | (1,230 | ) |
Total other income (expense) | 2,966 |
| | (4,801 | ) | | (2,702 | ) | | (10,532 | ) |
Pretax net loss | (161,982 | ) | | (3,069 | ) | | (169,335 | ) | | (11,661 | ) |
Income tax (benefit) provision | (1,717 | ) | | (28 | ) | | (562 | ) | | 948 |
|
Net loss | $ | (160,265 | ) | | $ | (3,041 | ) | | $ | (168,773 | ) | | $ | (12,609 | ) |
Three Months Ended September 30, 2015 Compared to the Three Months Ended September 30, 2014
Revenues. Revenues were $43.0 million for the three months ended September 30, 2015 compared to $51.0 million for the three months ended September 30, 2014, representing a decrease of $8.0 million, or 15.7%. The decrease was the result of a decrease in the U.S. region ($7.4 million) and a decrease in the International region ($0.6 million).
U.S. revenues were $27.4 million for the three months ended September 30, 2015 compared to $34.8 million for the three months ended September 30, 2014, representing a decrease of $7.4 million, or 21.3%. The decrease was the result of lower sales direct to hospitals ($6.0 million) and a decrease in sales to stocking distributors. ($1.4 million).
International revenues were $15.6 million for the three months ended September 30, 2015 compared to $16.2 million for the three months ended September 30, 2014, representing a decrease of $0.6 million, or 3.7%. The decrease was the result of an unfavorable exchange rate effect ($2.7 million), offset by growth in implant and instrument sales ($2.1 million).
Cost of revenues. Cost of revenues was $14.2 million for the three months ended September 30, 2015 compared to $14.3 million for the three months ended September 30, 2014, representing a decrease of $0.1 million, or 0.8%. The decrease was the result of a reduction in product costs due to volume and mix ($0.4 million), a reduction in reserves and adjustments ($0.8 million), a reduction in royalty expenses due to a reduction sales volume ($0.4 million), and a reduction in amortization expenses ($0.2 million), offset by non-recurring favorable royalties and milestones in 2014 ($1.2 million) and an increase in manufacturing depreciation expense due to the reduction in useful lives resulting from the production outsourcing initiative ($0.5 million).
Amortization of acquired intangible assets. Amortization of acquired intangible assets was $0.4 million for the three months ended September 30, 2015 and for the three months ended September 30, 2014. This expense represented amortization in the period for intangible assets associated with product related assets obtained in acquisitions.
Gross profit. Gross profit was $28.5 million for the three months ended September 30, 2015 compared to $36.3 million for the three months ended September 30, 2014, representing a decrease of $7.8 million, or 21.6%. The decrease was due to a decline in sales volume ($8.0 million), offset by a reduction in cost of revenues ($0.2 million).
Gross margin. Gross margin was 66.2% for the three months ended September 30, 2015 compared to 71.2% for the three months ended September 30, 2014. The decrease of 5.0 percentage points was due to increased cost of revenues resulting from non-recurring favorable royalties and milestones in 2014 (2.3 percentage points), an increase in manufacturing depreciation expense due to the reduction in useful lives resulting from the production outsourcing initiative (1.3 percentage points), an increase in instrument depreciation as a percentage of revenue (0.7 percentage points) and an unfavorable variation in regional mix, currency and product mix (2.4 percentage points), offset by a reduction in inventory reserves and adjustments (1.2 percentage points), a reduction in amortization expenses (0.3 percentage points) and a reduction in royalty costs due to a change in product mix (0.2 percentage points).
Gross margin for the U.S. region was 69.5% for the three months ended September 30, 2015 compared to 75.8% for the three months ended September 30, 2014. The decrease of 6.3 percentage points was due to increased cost of revenues resulting from non-recurring favorable royalties and milestones in 2014 (3.4 percentage points), an increase in manufacturing depreciation expense due to the reduction in useful lives resulting from the production outsourcing initiative (2.0 percentage points), increased instrument depreciation expense as a percentage of revenue (1.2 percentage points), unfavorable variation in pricing and product mix (0.4 percentage points) and increased royalty costs due to a change in product mix (0.3 percentage points), offset by a decrease in inventory reserves and adjustments (0.5 percentage points) and a reduction in amortization expenses (0.5 percentage points).
Gross margin for the International region was 60.5% for the three months ended September 30, 2015 compared to 61.3% for the three months ended September 30, 2014. The decrease of 0.8 percentage points was due to unfavorable variation in regional mix, currency and product mix (4.1 percentage points), offset by a reduction in inventory reserves and adjustments (2.1 percentage points), a reduction in royalty costs due to a change in product mix (0.9 percentage points) and a reduction in amortization expenses (0.3 percentage points).
In-process research and development expense. In-process research and development expense was $0.3 million for the three months ended September 30, 2015 compared to $0.5 million for the three months ended September 30, 2014, representing a decrease of $0.3 million. The $0.3 million expense in 2015 relates to payments on asset purchase agreements for which the underlying product was not technologically feasible at the time the asset was acquired.
Research and development expense. Research and development expense was $1.9 million for the three months ended September 30, 2015 compared to $4.4 million for the three months ended September 30, 2014, representing a decrease of $2.5 million, or 57.1%. The decrease was related to the reduction in stock compensation provided to outside consultants ($1.5 million), a reduction in personnel costs ($0.6 million) and the timing of development activities and product launch schedules ($0.4 million).
Sales and marketing expense. Sales and marketing expense was $17.1 million for the three months ended September 30, 2015 compared to $18.6 million for the three months ended September 30, 2014, representing a decrease of $1.5 million, or 8.1%. The decrease was primarily the result of a decrease in commission expense due to reduction in U.S. regional revenue.
General and administrative expense. General and administrative expense was $8.1 million for the three months ended September 30, 2015 compared to $10.2 million for the three months ended September 30, 2014, representing of a decrease of $2.1 million, or 20.7%. The decrease was primarily due to a refund of states use tax ($0.4 million), a reduction in personnel expenses ($1.0 million) and a reduction in general consulting expenses ($0.7 million).
Amortization of acquired intangible assets. Amortization of acquired intangible assets was $0.5 million for the three months ended September 30, 2015 compared to $0.7 million for the three months ended September 30, 2014. This expense represents amortization in the period for intangible assets associated with general business assets obtained in acquisitions.
Goodwill and intangible impairment. Goodwill and intangible assets impairment was $165.2 million for the three months ended September 30, 2015. This expense consists of the expensing of the premium paid over fair value for businesses acquired in prior periods and the impairment of intangible assets.
Restructuring expense. Restructuring expense was $0.3 million for the three months ended September 30, 2015 compared to less than $0.1 million for the three months ended September 30, 2014. In September 2013, we announced that Scient'x had begun a process to significantly restructure its business operations in France in an effort to improve operating efficiencies and rationalize its cost structure. As of September 30, 2015, substantially all of the activities associated with the Scient'x restructuring are completed and substantially all of the costs associated with that restructuring have been paid. In July 2015, we announced a restructuring of its manufacturing operations in California in an effort to improve its cost structure. The restructuring includes a reduction in workforce and closing the California manufacturing facility. The restructuring will take
place over the next year and the Company estimates that it will incur termination benefits, accelerated depreciation and facility closing and other restructuring costs up to $4 million.
Interest expense, net. Interest expense, net, was $3.1 million for the three months ended September 30, 2015 and $3.9 million for the three months ended September 30, 2014 representing a decrease of $0.8 million, or 19.7%. The decrease was primarily due to lower debt offering cost amortization related to the Deerfield facility.
Other income (expense), net. Other income (expense) was net income of $6.1 million for the three months ended September 30, 2015 compared to net expense of $0.9 million for the three months ended September 30, 2014, representing an increase in income of $7.0 million. The increase in income was due primarily to a decrease in the fair value of common stock warrant liability ($5.8 million) and net favorable foreign currency exchange results realized in 2015 due to having non-functional currency denominated assets and liabilities on subsidiaries books ($1.2 million).
Income tax (benefit) provision. Income tax (benefit) provision was $(1.7) million for the three months ended September 30, 2015 and less than $(0.1) million for the three months ended September 30, 2014. The 2015 income tax benefit consists primarily of the reversal of deferred tax liabilities associated with tax deductible goodwill, partially offset by state and foreign income taxes. The 2014 income tax benefit consists primarily of state and foreign income taxes and the tax effect of changes in deferred tax liabilities associated with tax deductible goodwill.
Nine Months Ended September 30, 2015 Compared to the Nine Months Ended September 30, 2014
Revenues. Revenues were $138.3 million for the nine months ended September 30, 2015 compared to $153.4 million for the nine months ended September 30, 2014, representing a decrease of $(15.1) million, or 9.8%. The decrease was the result of a decrease in the U.S. region ($16.3 million), offset by an increase in the International region ($1.2 million).
U.S. revenues were $85.1 million for the nine months ended September 30, 2015 compared to $101.4 million for the nine months ended September 30, 2014, representing a decrease of $16.3 million, or 16.1% . The decrease was the result of lower sales direct to hospitals ($14.2 million) and a decrease in stocking revenue ($2.1 million).
International revenues were $53.2 million for the nine months ended September 30, 2015 compared to $52.0 million for the nine months ended September 30, 2014, representing an increase of $1.2 million, or 2.3% . The increase was the result of the growth in implants and instruments sales ($10.6 million), offset by an unfavorable exchange rate effect ($9.4 million).
Cost of revenues. Cost of revenues was $48.2 million for the nine months ended September 30, 2015 compared to $46.3 million for the nine months ended September 30, 2014, representing an increase of $1.9 million, or 4.2%. The increase was the result of charges for the impairment of certain product related intangible assets and the disposal of manufacturing equipment ($1.9 million), non-recurring favorable royalties and milestones in 2014 ($1.2 million), an increase in manufacturing depreciation expense due to the reduction of useful lives resulting from the production outsourcing initiative ($0.5 million), and an increase in product costs due to mix ($0.7 million), offset by reduced instrument depreciation expense ($0.8 million), a decrease in inventory reserves and other adjustments ($1.0 million), a decrease in royalty expenses due to volume and product mix ($0.3 million), and a reduction in amortization expense ($0.3 million).
Amortization of acquired intangible assets. Amortization of acquired intangible assets was $1.1 million for the nine months ended September 30, 2015 compared to $1.3 million for the nine months ended September 30, 2014. This expense represents amortization in the period for intangible assets associated with product related assets obtained in acquisitions.
Gross profit. Gross profit was $88.9 million for the nine months ended September 30, 2015 compared to $105.7 million for the nine months ended September 30, 2014, representing a decrease of ($16.8 million), or (15.9)%. The decrease was due to an increase in cost of revenues ($1.7 million) combined with the decline in sales volume ($15.1 million).
Gross margin. Gross margin was 64.3% for the nine months ended September 30, 2015 compared to 68.9% for the nine months ended September 30, 2014. The decrease of 4.6 percentage points was due to increased cost of revenues resulting from one-time charges (2.5 percentage points), increased royalty costs due to a change in product mix (0.2 percentage points) and unfavorable variation in regional mix, currency and product mix (2.7 percentage points), offset by a decrease in amortization expense (0.3 percentage points) and decrease in inventory reserves and other adjustments (0.5 percentage points).
Gross margin for the U.S. region was 66.5% for the nine months ended September 30, 2015 compared to 73.2% for the nine months ended September 30, 2014. The decrease of (6.7) percentage points was due to increased cost of revenues resulting from one-time charges (4.1 percentage points), unfavorable variation in pricing and product mix (2.0 percentage points), increased royalty costs due to a change in product mix (0.5 percentage points) and an increase in instrument depreciation expense (0.4 percentage points), offset by a decrease in inventory reserves and adjustments (0.1 percentage points) and a decrease in amortization expense (0.2 percentage points)
Gross margin for the International region was 60.8% for the nine months ended September 30, 2015 compared to 60.6% for the nine months ended September 30, 2014. The increase of 0.2 percentage points was due to reduced instrument depreciation expense (0.5 percentage points), a reduction in amortization of acquired intangibles (0.5 percentage points) and a decrease in inventory reserves and adjustments (0.9 percentage points), offset by unfavorable variation in pricing and product mix (1.7 percentage points).
Research and development expense. Research and development expense was $9.7 million for the nine months ended September 30, 2015 compared to $13.1 million for the nine months ended September 30, 2014, representing a decrease of $(3.5) million, or 26.5%. The decrease was related to the reduction in stock compensation provided to outside consultants ($1.7 million), a reduction in personnel costs ($0.7 million) and the timing of development activities and product launch schedules ($1.1 million).
In-process research and development expense. In-process research and development expense was $0.3 million for the nine months ended September 30, 2015 compared to $0.5 million for the nine months ended September 30, 2014, representing a decrease of $0.3 million. The $0.3 million expense in 2015 relates to payments on asset purchase agreements for which the underlying product was not technologically feasible at the time the asset was acquired.
Sales and marketing expense. Sales and marketing expense was $52.0 million for the nine months ended September 30, 2015 compared to $56.5 million for the nine months ended September 30, 2014, representing a decrease of $(4.5) million, or 8.1%. The decrease was due to decrease in selling and marketing activities due to the timing of activity ($0.8 million), and a decrease in commission expense due to reduction in U.S. regional revenue ($3.7 million).
General and administrative expense. General and administrative expense was $26.5 million for the nine months ended September 30, 2015 compared to $33.7 million for the nine months ended September 30, 2014, representing a decrease of $(7.2) million, or 21.4%. The decrease was due to a reduction in legal expenses associated with the Orthotec litigation ($4.2 million), a sales tax refund ($0.4 million) and a reduction in personnel and professional fees ($2.6 million).
Amortization of acquired intangible assets. Amortization of acquired intangible assets was $1.9 million for the nine months ended September 30, 2015 compared to $2.3 million for the nine months ended September 30, 2014. This expense represents amortization in the period for intangible assets associated with general business assets obtained in acquisitions.
Goodwill and intangible impairment. Goodwill and intangible assets impairment was $165.2 million for the nine months ended September 30, 2015 compared to zero for the nine months ended September 30, 2014. This expense consists of the expensing of the premium paid over fair value for businesses acquired in prior periods and the impairment of intangible assets.
Restructuring expense. Restructuring expense was $0.2 million for the nine months ended September 30, 2015 compared to $0.7 million for the nine months ended September 30, 2014. On September 16, 2013, we announced that Scient'x had begun a process to significantly restructure its business operations in France in an effort to improve operating efficiencies and rationalize its cost structure. As of September 30, 2015 substantially all the activities associated with the restructuring were completed and substantially all of the costs associated with the restructuring have been paid. In July 2015, we announced a restructuring of our manufacturing operations in California in an effort to improve our cost structure. The restructuring includes a reduction in workforce and closing the California manufacturing facility. The restructuring will take place over the next year and we estimate that we will incur termination benefits, accelerated depreciation and facility closing and other restructuring costs up to $4 million in the aggregate.
Interest expense, net. Interest expense was $9.5 million for the nine months ended September 30, 2015 and $9.3 million for the nine months ended September 30, 2014 representing an increase of $0.2 million, or 2.0%. The increase is due to interest expense and amortization of debt discount related to the Deerfield facility.
Other income (expense), net. Other income (expense), net was income of $6.8 million for the nine months ended September 30, 2015 compared to expense of $1.2 million for the nine months ended September 30, 2014. The increase in income for the nine months ended September 30, 2015 was due to the change in fair value of common stock warrant liability ($8.0 million), partially offset by unfavorable foreign currency exchange results due to having non-functional currency denominated assets and liabilities on subsidiaries books ($0.3 million).
Income tax (benefit) provision. Income tax (benefit) provision was a benefit of $(0.6) million for the nine months ended September 30, 2015 compared to a provision of $0.9 million for the nine months ended September 30, 2014. The 2015 income tax benefit consists primarily of the reversal of deferred tax liabilities associated with tax deductible goodwill, partially offset by state and foreign income taxes. The 2014 income tax expense consists primarily of state and foreign income taxes and the tax effect of changes in deferred tax liabilities associated with tax deductible goodwill.
Non-GAAP Financial Measures
We utilize certain financial measures that are not calculated based on U.S. generally accepted accounting principles, or GAAP. Certain of these financial measures are considered “non-GAAP” financial measures within the meaning of Item 10 of Regulation S-K promulgated by the SEC. We believe that non-GAAP financial measures reflect an additional way of viewing aspects of our operations that, when viewed with the GAAP results, provide a more complete understanding of our results of operations and the factors and trends affecting our business. These non-GAAP financial measures are unaudited and are also used by our management to evaluate financial results and to plan and forecast future periods. However, non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Non-GAAP financial measures used by us may differ from the non-GAAP measures used by other companies, including our competitors.
Adjusted EBITDA represents net income (loss) excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation, other income (expense) and other non-recurring income or expense items, such as asset impairments, litigation expenses and trial costs, in-process research and development expense and restructuring expenses. We believe that the most directly comparable GAAP financial measure to adjusted EBITDA is net income (loss). Adjusted EBITDA has limitations. Therefore, adjusted EBITDA should not be considered either in isolation or as a substitute for analysis of our results as reported under GAAP. Furthermore, adjusted EBITDA should not be considered as an alternative to operating income (loss) or net income (loss) as a measure of operating performance or to net cash provided by operating, investing or financing activities, or as a measure of our ability to meet cash needs.
The following is a reconciliation of adjusted EBITDA to the most comparable GAAP measure, net loss, for the three and nine months ended September 30, 2015 and 2014 (in thousands):
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2015 | | 2014 | | 2015 | | 2014 |
Net loss | $ | (160,265 | ) | | $ | (3,041 | ) | | $ | (168,773 | ) | | $ | (12,609 | ) |
Stock-based compensation | (78 | ) | | 1,502 |
| | 2,440 |
| | 3,641 |
|
Depreciation | 3,440 |
| | 2,895 |
| | 9,067 |
| | 9,247 |
|
Amortization of intangible assets | 188 |
| | 379 |
| | 2,072 |
| | 1,174 |
|
Amortization of acquired intangible assets | 884 |
| | 1,177 |
| | 2,960 |
| | 3,585 |
|
In-process research and development | 274 |
| | 527 |
| | 274 |
| | 527 |
|
Interest expense, net | 3,092 |
| | 3,873 |
| | 9,484 |
| | 9,302 |
|
Income tax (benefit) provision | (1,717 | ) | | (28 | ) | | (562 | ) | | 948 |
|
Other (income) expense, net | (6,058 | ) | | 928 |
| | (6,782 | ) | | 1,230 |
|
Goodwill and intangible impairment | 165,171 |
| | — |
| | 165,171 |
| | — |
|
Restructuring and other expense | 335 |
| | 20 |
| | 163 |
| | 742 |
|
Litigation expenses and trial costs | — |
| | — |
| | — |
| | 4,779 |
|
Adjusted EBITDA | $ | 5,266 |
| | $ | 8,232 |
| | $ | 15,514 |
| | $ | 22,566 |
|
Liquidity and Capital Resources
We have incurred significant net losses since inception and relied on our ability to fund our operations through revenues from the sale of our products, equity financings and debt financings. As we have incurred losses, successful transition to profitability is dependent upon achieving a level of revenues adequate to support our cost structure. This may not occur and, unless and until it does, we will continue to need to raise additional capital. Operating losses and negative cash flows may continue for at least the next year as we continue to incur costs related to the execution of our operating plan, introduction of new products and expansion into new geographies. Our amended and Restated credit facility, or the Amended Credit Facility, with MidCap Financial, LLC, or MidCap, matures in August 2016, which will require us to refinance the Amended Credit Facility with MidCap or seek alternative financing. As disclosed in Note 1 and Note 5 to the condensed consolidated financial statements in Item 1, we were not in compliance with the fixed charge coverage ratio covenant as of September 30, 2015 related to the Amended Credit Facility with MidCap for June, August and September of 2015. We obtained waivers from MidCap in January and February 2016 to cure the non-compliance for these periods. Our default under the Amended Credit Facility with MidCap also constitutes an event of default under our Facility Agreement with Deerfield (described in Note 1 and Note 5), and such default has been waived in February 2016 for these periods. There is no assurance that we will be in compliance with the financial covenants of the Amended Credit Facility in the future. If we have future defaults and we do not
obtain waivers from MidCap or Deerfield they would have the right to call their respective debts due immediately, which would significantly impact our ability to continue as a going concern. We intend to pursue additional opportunities to raise additional capital through public or private equity offerings, debt financings, receivables financings or collaborations or partnerships with other companies to further support our planned operations. However, there is no assurance that we will be able to do so.
Historically, our principal sources of cash have included customer payments from the sale of our products, proceeds from the issuance of common and preferred stock and proceeds from the issuance of debt. Our principal uses of cash have included cash used in operations, acquisitions of businesses and intellectual property rights, payments relating to purchases of surgical instruments, repayments of borrowings under our Amended Credit Facility with MidCap, and payments due under the Orthotec settlement agreements. We expect that our principal uses of cash in the future will be for operations, working capital, capital expenditures, and potential acquisitions. We expect that, as our revenues grow, our sales and marketing and research and development expenses will continue to grow and, as a result, we will need to generate significant net revenues to achieve profitability. We anticipate that if we require additional liquidity for operations, it will be funded through borrowings under our Amended Credit Facility, the incurrence of other indebtedness, additional equity financings or a combination of these potential sources of liquidity.
We will need to invest in working capital and surgical instruments (the costs of which are capitalized) in order to support our revenue projections through the end of 2015. If we are not able to achieve our revenue forecast and cash consumption starts to exceed forecasted consumption, management will need to adjust our investment in surgical instruments and manage our inventory to the decreased sales volumes. If we do not make these adjustments in a timely manner, there could be an adverse impact on our financial resources. Our revenue projections may be negatively impacted as a result of a decline in sales of our products, including declines due to changes in our customers’ ability to obtain third-party coverage and reimbursement for procedures that use our products, increased pricing pressures resulting from intensifying competition, and cost increases and slower product development cycles resulting from a changing regulatory environment.
On July 6, 2015, we announced a restructuring of our manufacturing operations in California in an effort to improve our cost structure. The restructuring includes a reduction in workforce and closing the California manufacturing facility. The restructuring will take place over the next year and we estimate that we will incur termination benefits, accelerated depreciation and facility closing and other restructuring costs of up to $4 million.
A substantial portion of our available cash funds is held in business accounts with reputable financial institutions. At times, however, our deposits, may exceed federally insured limits and thus we may face losses in the event of insolvency of any of the financial institutions where our funds are deposited. We did not hold any marketable securities as of September 30, 2015.
Amended Credit Facility and Other Debt
On August 30, 2013, we entered into the Amended Credit Facility with MidCap. The Amended Credit Facility amended and restated the prior credit facility that we had with MidCap (the "Prior Credit Facility"). Pursuant to the Amended Credit Facility, we increased the borrowing limit from $50 million to $73 million. We also extended the maturity to August 2016. In July 2015, we further amended the Amended Credit Facility to provide for an additional term loan of $5 million. As of September 30, 2015, the Amended Credit Facility consisted of a $38 million term loan, $28 million of which was drawn at closing, and a revolving line of credit with a maximum borrowing base of $40 million, of which $27.0 million was outstanding under the revolving line of credit at September 30, 2015. We used the term loan proceeds of $28 million drawn at closing to repay a portion of the outstanding balance on the prior revolving line of credit.
The term loan interest rate is priced at the London Interbank Offered Rate ("LIBOR") plus 8.0%, subject to a 9.5% floor, and the revolving line of credit interest rate remains priced at LIBOR plus 6.0%, reset monthly. At September 30, 2015, the revolving line of credit carried an interest rate of 6.2% and the term loan carries an interest rate of 9.5%. The borrowing base is determined, from time to time, based on the value of domestic eligible accounts receivable and domestic eligible inventory. As collateral for the Amended Credit Facility, we granted MidCap a security interest in substantially all of its assets, including all accounts receivable and all securities evidencing its interests in its subsidiaries. In addition to monthly payments of interest, monthly repayments of $0.5 million are due through maturity, with the remaining principal due upon maturity.
In connection with the execution of the Amended Credit Facility, we incurred an additional $0.4 million in costs that were capitalized as debt issuance costs. At September 30, 2015, $0.3 million remains as unamortized debt issuance costs related to the Amended Credit Facility and the prior credit facility with MidCap within the unaudited consolidated balance sheet, which will be amortized over the remaining term of the Amended Credit Facility.
The Amended Credit Facility includes traditional lending and reporting covenants including a fixed charge coverage ratio, a senior leverage ratio and a total leverage ratio to be maintained by us. The Amended Credit Facility also includes several
potential events of default, such as payment default and insolvency conditions, 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 MidCap’s right to declare all outstanding obligations immediately due and payable. We are in compliance with all of the covenants of the Amended Credit Facility as of September 30, 2015 except as disclosed in Note 1 and Note 5 of the condensed consolidated financial statements included under Item 1 of this report.
On March 17, 2014, we entered into a first amendment to the Amended Credit Facility with MidCap (the "First Amendment to the Amended Credit Facility"). Under the First Amendment to the Amended Credit Facility, MidCap gave us its consent to enter into the Facility Agreement and make settlement payments in connection with the Orthotec litigation. The First Amendment to the Amended Credit Facility also added a total leverage ratio financial covenant.
On July 10, 2015, we entered into a Second Amendment to the Amended Credit Facility with MidCap (the "Second Amendment") to increase the term loan commitment from $33 million to $38 million. We borrowed the additional $5 million on July 10, 2015, which is the third term loan tranche under the Amended Credit Facility (the"Third Term Loan Tranche"). Until January 1, 2016, only interest payments are due for the Third Term Loan Tranche. Thereafter, we will pay an amount equal to $0.5 million on the first day of each calendar month as an amortization payment in respect of all tranches of the term loan. We agreed to pay MidCap, a commitment fee equal to 1.0% of the principal amount of the funds disbursed in the Third Term Loan Tranche.
We have various capital lease arrangements. The leases bear interest at rates ranging from 6.6% to 9.6% per annum, are generally due in monthly principal and interest installments, are collateralized by the related equipment, and have various maturity dates through September 2018. As of September 30, 2015, the balance of these capital leases, net of interest totaled $1.5 million.
Operating Activities
We generated net cash of $5.6 million from operating activities for the nine months ended September 30, 2015. During this period, net cash provided by operating activities primarily consisted of a net loss of $168.8 million and working capital and other assets used of $6.8 million, which were offset by $181.1 million of non-cash costs including goodwill and intangible impairment, amortization, depreciation, deferred income taxes, stock-based compensation, provision for doubtful accounts, provision for excess and obsolete inventory, and interest expense related to amortization of debt discount and issue costs and in -process research and development expenses. Working capital and other assets used of $6.8 million primarily consisted of increases in inventories of $2.2 million, and decreases accrued expenses and other liabilities of $12.6 million, partially offset by decreases in restricted cash of $3.3 million, accounts receivable of $3.5 million and prepaid expenses and other current assets of $1.9 million.
Investing Activities
We used cash of $8.7 million, net of accounts payable, in investing activities for the nine months ended September 30, 2015, with the majority $8.7 million being used for the purchase of surgical instruments.
Financing Activities
Financing activities used net cash of $6.5 million for the nine months ended September 30, 2015. On the Amended Credit Facility with MidCap we borrowed an aggregate of $105.5 million and made principal payments totaling $110.4 million during the nine months ended September 30, 2015. We made principal payments on notes payable and capital leases totaling $6.7 million in the nine months ended September 30, 2015.
Contractual obligations and commercial commitments
Total contractual obligations and commercial commitments as of September 30, 2015 are summarized in the following table (in thousands):
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Payment Due by Year |
| | | 2015 | | | | | | | | | | |
| Total | | (3 months) | | 2016 | | 2017 | | 2018 | | 2019 | | Thereafter |
Amended Credit Facility with MidCap (2) | $ | 56,353 |
| | $ | 1,402 |
| | $ | 54,951 |
| | $ | — |
| | $ | — |
| | $ | — |
| | $ | — |
|
Credit Facility with Deerfield (2) | 26,000 |
| | — |
| | — |
| | 8,667 |
| | 8,667 |
| | 8,666 |
| | — |
|
Interest expense (2) | 9,514 |
| | 1,659 |
| | 5,011 |
| | 1,706 |
| | 948 |
| | 190 |
| | — |
|
Notes payable for software licenses | 264 |
| | 122 |
| | 142 |
| | — |
| | — |
| | — |
| | — |
|
Note payable for insurance premiums | 1,614 |
| | 534 |
| | 1,080 |
| | — |
| | — |
| | — |
| | — |
|
Capital lease obligations | 1,606 |
| | 224 |
| | 877 |
| | 437 |
| | 68 |
| | — |
| | — |
|
Operating lease obligations | 4,472 |
| | 899 |
| | 2,318 |
| | 846 |
| | 272 |
| | 137 |
| | — |
|
Litigation settlement obligations | 35,933 |
| | 1,100 |
| | 4,400 |
| | 4,400 |
| | 4,400 |
| | 4,400 |
| | 17,233 |
|
Guaranteed minimum royalty obligations | 8,943 |
| | 852 |
| | 2,286 |
| | 1,950 |
| | 1,868 |
| | 1,118 |
| | 869 |
|
New product development milestones (1) | 400 |
| | — |
| | — |
| | 200 |
| | — |
| | 200 |
| | — |
|
Total | $ | 145,099 |
| | $ | 6,792 |
| | $ | 71,065 |
| | $ | 18,206 |
| | $ | 16,223 |
| | $ | 14,711 |
| | $ | 18,102 |
|
__________________________
| |
(1) | This commitment represents payments in cash, and is subject to attaining certain sales milestones, development milestones such as U.S. Food and Drug Administration approval, product design and functionality testing requirements, which we believe are reasonably likely to be achieved during the period from 2015 through 2019. |
| |
(2) | The amounts above are presented based on the contractual payment schedules in each of the respective agreements. However, the debt balance under the Amended Credit Facility and Facility Agreement was callable as of September 30, 2015 due to the event of default (See Note 1 and Note 5) and therefore, is presented as a current liability on the condensed consolidated balance sheet as of September 30, 2015. |
Stock-based Compensation
Stock-based compensation has been classified as follows in the accompanying condensed consolidated statements of operations (in thousands, except per share data):
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2015 |
| 2014 | | 2015 | | 2014 |
Cost of revenues | $ | 26 |
| | $ | 94 |
| | $ | 79 |
| | $ | 240 |
|
Research and development | (804 | ) | | 699 |
| | 223 |
| | 1,809 |
|
Sales and marketing | 132 |
| | 141 |
| | 385 |
| | 351 |
|
General and administrative | 568 |
| | 568 |
| | 1,753 |
| | 1,241 |
|
Total | $ | (78 | ) | | $ | 1,502 |
| | $ | 2,440 |
| | $ | 3,641 |
|
Effect on basic and diluted net loss per share | $ | — |
| | $ | (0.01 | ) | | $ | (0.02 | ) | | $ | (0.02 | ) |
Recent Accounting Pronouncements
In May 2014, the FASB issued new accounting guidance related to revenue recognition. This new standard will replace all current U.S. GAAP guidance on this topic and eliminate all industry-specific guidance. The new revenue recognition standard provides a unified model to determine when and how revenue is recognized. The core principle is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. On August 12, 2015, the FASB issued guidance deferring the effective date by one year to December 15, 2017 for annual reporting periods beginning after that date. The FASB also permitted early adoption of the standard, but not before the original effective date of December 15, 2016. The Company is currently evaluating the impact, if any, the adoption of this standard will have on its financial statements.
In August 2014, the FASB issued guidance related to disclosures of uncertainties about an entity’s ability to continue as a going concern. The guidance requires management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued. Management will be required to make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. Substantial doubt exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. The guidance is effective for annual periods ending after December 15, 2016 and for interim reporting periods within annual periods beginning after December 15, 2016, with early adoption permitted. We are currently evaluating the impact of this guidance and expect to adopt the standard for the annual reporting period ended December 31, 2016.
In April 2015, the FASB issued guidance that amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. The guidance will not change the amortization of debt issuance costs, which will continue to follow the existing accounting guidance.This guidance is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. We are currently evaluating the impact of adopting this new accounting standard on our financial statements.
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, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act, including statements regarding:
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• | our estimates regarding anticipated operating losses, future revenue, expenses, capital requirements, uses and sources of cash and liquidity, including our anticipated revenue growth and cost savings; |
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• | 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; |
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• | our beliefs about the features, strengths and benefits of our products; |
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• | the effect of our strategy to streamline our organization and lower our costs; |
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• | our expectations about the timing, costs and benefits of the restructuring and outsourcing of our manufacturing operations; |
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• | our ability to successfully integrate, and realize benefits from licenses and acquisitions; |
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• | our ability to successfully achieve and maintain regulatory clearance or approval for our products in applicable jurisdictions and in a timely manner; |
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• | the effect of any existing or future federal, state or international regulations on our ability to effectively conduct our business; |
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• | our estimates of market sizes and anticipated uses of our products; |
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• | our business strategy and our underlying assumptions about market data, demographic trends, reimbursement trends and pricing trends; |
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• | our ability to achieve profitability, and the potential need to raise additional funding; |
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• | our ability to maintain an adequate sales network for our products; |
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• | our ability to increase the use and promotion of our products by training and educating surgeons and our sales network; |
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• | our ability to attract and retain a qualified management team, as well as other qualified personnel and advisors; |
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• | our ability to enter into licensing and business combination agreements with third parties; |
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• | our ability to protect our intellectual property, and to not infringe upon the intellectual property of third parties; |
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• | our ability to regain and maintain compliance with the quality requirements of the FDA and similar regulatory authorities outside of the U.S.; |
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• | the effects of the escalating cost of medical products and services and the effects of market demand, government regulation, third-party reimbursement policies and societal pressures on the worldwide healthcare industry and our business; |
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• | our ability to meet the financial covenants under our credit facilities, to obtain waivers from our lenders with respect to any noncompliance with our financial covenants, and to refinance our existing debt prior to the maturity of our credit facilities with our current or new lenders; |
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• | our ability to regain and maintain compliance with the continued listing requirements of The NASDAQ Global Select Market; |
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• | our ability to resolve the deficiencies cited in the warning letter that we received from the FDA in July 2015 following the FDA's inspection of our manufacturing facilities; |
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• | our ability to ensure that we have effective disclosure controls and procedures and to remedy our material weakness in our internal control over financial reporting; |
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• | our ability to meet or exceed the industry standard in clinical and legal compliance and corporate governance programs; |
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• | potential liability resulting from litigation; |
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• | potential liability resulting from a governmental review of our business practices; |
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• | our beliefs about the usefulness of the non-GAAP financial measures included in this Quarterly Report on Form 10-Q; |
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• | our ability to meet and potential liability from not meeting the payment obligations under the Orthotec settlement agreement; |
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• | 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.
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, 2014 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, 2014 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.
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Interest Rate Risk
Our borrowings under our Credit Facility expose us to market risk related to changes in interest rates. As of September 30, 2015, our outstanding floating rate indebtedness totaled $56.4 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 $0.6 million. Other outstanding debt consists of fixed rate instruments, including debt outstanding under the Facility Agreement, notes payable and capital leases.
Foreign Currency Risk
Our foreign currency exposure continues to grow as we seek to expand internationally. Our exposure to foreign currency transaction gains and losses is primarily the result of certain net receivables due from our foreign subsidiaries and customers being denominated in currencies other than the U.S. dollar, primarily the Euro and Japanese Yen, in which our revenues and profits are denominated. We had unfavorable foreign currency exchange results realized in 2015 due to having U.S. dollar denominated assets and liabilities on foreign subsidiaries books. We do not currently engage in hedging or similar transactions to reduce these risks. Fluctuations in currency exchange rates could impact our results of operations, financial position and cash flows.
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 revenues, 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 nine months ended September 30, 2015.
Equity Price Risk
In connection with the Facility Agreement with Deerfield, we have issued warrants to purchase 11,450,000 shares of our common stock. We recorded the warrant liability at fair value and adjust the carrying value of these common stock warrants to their estimated fair value at each reporting date, with the increases or decreases in the fair value of such warrants at each reporting date recorded as other income (expense) in our consolidated statement of operations. A 10 percent increase in our stock price from its September 30, 2015 closing price of $0.33 per share would increase the fair value of the warrant liability by approximately $0.1 million with a corresponding charge to the Statements of Operations.
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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 the 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 defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls
and procedures were not effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. This conclusion was a result of a material weakness as described below in the Company’s internal control over financial reporting that existed at September 30, 2015 and had not been remediated by the end of the period covered by this Quarterly Report on Form 10-Q.
Material Weakness in Internal Control Over Financial Reporting
The Company’s management, including our Chief Executive Officer and Chief Financial Officer, identified a material weakness in the Company’s internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.
The Amended Credit Facility with MidCap includes certain financial debt covenants. Subsequent to filing the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2015, filed on November 3, 2015, the Company discovered that the Company was not in compliance with a financial debt covenant related to the Amended Credit Facility with MidCap for June, August and September of 2015. The Company failed to design effective controls to assess whether it is in compliance with the debt covenants, which resulted in the restatement of the Company's condensed consolidated balance sheets as of June 30, 2015 and September 30, 2015. Based on this assessment and the material weakness described above, management concluded that the Company’s internal control over financial reporting was not effective as of June 30, 2015 and September 30, 2015.
Remediation Measures
To address the material weakness described above, the Company has designed and implemented new and enhanced controls to ensure that the calculation of the fixed charge coverage ratio reflects an accurate interpretation of the definitions in the underlying debt agreement and that the appropriate level of review is performed.
The Company believes the actions described above will be sufficient to remediate the identified material weakness and strengthen our internal control over financial reporting. However, the new and enhanced controls have not operated for a sufficient amount of time to conclude that the material weakness has been remediated. The Company will continue to monitor the effectiveness of these controls and will make any further changes management determines appropriate.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control that occurred during the quarter ended September 30, 2015 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, other than the changes discussed above under "Remediation Measures."
PART II. OTHER INFORMATION
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, the Company believes the ultimate disposition of the above matter that 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 our 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 us may be unsupported, exaggerated or unrelated to reasonably possible outcomes, and as such are not meaningful indicators of the Company’s potential liability.
The following are material changes to the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission on February 26, 2015.
We may be unable to comply with the covenants of our credit facilities.
We must comply with certain affirmative and negative covenants, including financial covenants, in our Amended Credit Facility with MidCap and affirmative and negative covenants in our Facility Agreement with Deerfield. We determined that we failed to comply with the fixed charge coverage ratio covenant under our Amended Credit Facility with MidCap in June, August and September of 2015, but MidCap and Deerfield have provided waivers of our failure to comply with the covenant during such periods. Even though we obtained waivers from MidCap and Deerfield in January and February of 2016 for the periods above, there can be no assurance that at all times in the future we will satisfy all such financial or other covenants of the MidCap Amended Credit Facility or the Deerfield Facility Agreement, or obtain any required waiver or amendment, in which event of default the lenders party to the MidCap Amended Credit Facility could refuse to make further extensions of credit to us and MidCap and/or Deerfield could require all amounts borrowed under the MidCap Amended Credit Facility and/or the Facility Agreement, respectively, together with accrued interest and other fees, to be immediately due and payable. In addition to allowing the lenders to accelerate the loan, several events of default under the MidCap Amended Credit Facility, such as our failure to make required payments of principal and interest and the occurrence of certain bankruptcy or insolvency events, could require us to pay interest at a rate which is up to five percentage points higher than the interest rate effective immediately before the event of default.
An event of default under the MidCap Amended Credit Facility or the Deerfield Facility Agreement could have a material adverse effect on us. Upon an event of default, if the lenders under the MidCap Amended Credit Facility accelerate the repayment of all amounts borrowed, together with accrued interest and other fees, or if the lenders elect to charge us additional interest, we cannot assure you that we will have sufficient cash available to repay the amounts due, and we may be forced to seek to amend the terms of the MidCap Amended Credit Facility or the Deerfield Facility Agreement or obtain alternative financing, which may not be available to us on acceptable terms, if at all.
In addition, if we fail to pay amounts when due under the MidCap Amended Credit Facility or the Deerfield Facility Agreement or upon the occurrence of another event of default, the lenders under the MidCap Amended Credit Facility or the Deerfield Facility Agreement could proceed against the collateral granted to them pursuant to the MidCap Amended Credit Facility and the Deerfield Facility Agreement. We have granted to the lenders under the MidCap Amended Credit Facility a
first priority security interest in substantially all of our assets, including all accounts receivable and all securities evidencing our interests in our subsidiaries, as collateral under the MidCap Amended Credit Facility. If the lenders proceed against the collateral, such assets would no longer be available for use in our business, which would have a significant adverse effect our business, financial condition and results of operations.
For the quarters ended June 30, 2015 and September 30, 2015, we determined that we had a material weakness in our internal control over financial reporting. As a result, current and potential stockholders could lose confidence in our financial reporting which would harm our business and the trading of our stock.
For the quarters ended June 30, 2015 and September 30, 2015, we determined that we had a material weakness in our internal control over financial reporting. Our efforts to comply with Sections 302 and 404 of the Sarbanes-Oxley Act of 2002 and the related regulations regarding our required assessment of our internal control over financial reporting and our independent auditor’s audit of that assessment requires the commitment of significant financial and managerial resources.
The Amended Credit Facility with MidCap includes certain financial debt covenants. Subsequent to filing the Quarterly Report on Form 10-Q for the quarterly periods ended June 30, 2015, filed on August 4, 2015 and September 30, 2015, filed on November 3, 2015, we discovered that we were not in compliance with the fixed charge coverage ratio covenant under the Amended Credit Facility with MidCap for June, August and September 2015. We obtained waivers from MidCap to cure the non-compliance for these periods. As a result of our failure to comply with the fixed coverage ratio covenant under the Amended Credit Facility, we were also in default under the Facility Agreement with Deerfield, for which we also obtained a waiver for the previously mentioned periods. The aforementioned waivers from MidCap and Deerfield were received in January and February of 2016. As a result, we have determined to restate the condensed consolidated balance sheets as of June 30, 2015 and September 30, 2015 to classify the amounts due under the MidCap Amended Credit Facility and the Deerfield Facility Agreement as current portion of long-term debt, rather than long-term debt. We determined that we failed to design effective controls to assess whether we are in compliance with the debt covenants. This deficiency resulted in a material weakness, which is defined as a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of annual or interim consolidated financial statements will not be prevented or detected on a timely basis. To address the material weakness described above, we have designed and implemented new and enhanced controls to ensure that the calculation of the fixed charge coverage ratio reflects an accurate interpretation of the definitions in the underlying debt agreements and that the appropriate level of review is performed.
If we determine in future fiscal periods that we have other material weaknesses in our internal control over financial reporting, the reliability of our financial reports may be impacted or we could be required to restate our financial statements. In addition, our failure to successfully remediate a material weakness in the future could result in adverse consequences to us, including, but not limited to, a loss of investor confidence in the reliability of our financial statements, which could cause the market price of our stock to decline.
We have recognized significant goodwill impairment charges.
We account for goodwill in accordance with guidance that requires that goodwill be tested for impairment at least annually. We test goodwill for impairment in December of each year, or more frequently if events and circumstances warrant. These assets are impaired if we determine that their carrying values may not be recoverable based on an assessment of certain events or changes in circumstances. If the assets are considered to be impaired, we recognize the amount by which the carrying value of the assets exceeds the fair value of the assets as an impairment loss. In the third quarter of 2015, the market value of our common stock substantially declined. As a result of this decline, we determined that we had an indicator of impairment of our goodwill, and an interim test of goodwill impairment was required. As a result, we reviewed our goodwill for impairment under a two-part test in accordance with the relevant guidance. Based upon this two-part test, we determined that our goodwill was impaired, which required us to write off the entire balance of our goodwill. In the third quarter of 2015, we recorded a charge of $164.3 million representing the write-off of the balance of our goodwill. For additional information related to these charges, see the Goodwill subsection of Note 2 to the condensed consolidated financial statements included in this report.
In July of 2015 we received a warning letter from the FDA, and there is no guarantee that we can successfully remedy the deficiencies set forth in such warning letter.
On July 17, 2015, Alphatec Spine, Inc., our wholly owned subsidiary, received a Warning Letter from the FDA in connection with the FDA’s inspection of our manufacturing facilities located in Carlsbad, California that occurred from February 4, 2015 until March 13, 2015, or the Inspection. In the Warning Letter, the FDA cited eight deficiencies in our responses to the FDA Form 483, Inspectional Observations, which was issued to us at the end of the Inspection. The deficiencies relate to our internal procedures for quality planning, design control, document control and corrective and preventive actions. The Warning Letter does not restrict production or shipment of our products from our facilities, or the sale
or marketing of our products. We are currently addressing the deficiencies cited by the FDA in the Warning Letter and intend to work closely with the FDA to resolve any outstanding issues. Until the procedures noted in the Warning Letter are corrected, we may be subject to additional regulatory action by the FDA, and any such actions could significantly disrupt our ongoing business and operations and have a material adverse impact on our financial position and operating results. There can be no assurance that the FDA will be satisfied with our response.
If we fail to continue to meet all applicable NASDAQ Global Select Market requirements and our common stock is delisted, the delisting could adversely affect the market liquidity of our common stock, impair the value of your investment and harm our business.
Our common stock is currently listed on the NASDAQ Global Select Market. In order to maintain that listing, we must satisfy minimum financial and other requirements. On September 17, 2015, we received written notice from the Listing Qualifications Department of the NASDAQ Stock Market LLC, or NASDAQ, notifying us that for the preceding 30 consecutive business days, our common stock did not maintain a minimum closing bid price of $1.00 per share as required for continued inclusion on The NASDAQ Global Select Market under NASDAQ Listing Rule 5450(a)(1). The notification letter states that pursuant to NASDAQ Listing Rule 5810(c)(3)(A), we will be afforded 180 calendar days, or until March 15, 2016, to regain compliance with the minimum bid price requirement. In order to regain compliance, shares of our common stock must maintain a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during such 180-day period. If we do not regain compliance by March 15, 2016, NASDAQ will provide written notification to us that our common stock will be delisted. At that time, we may appeal NASDAQ’s delisting determination to a NASDAQ Listing Qualifications Panel. Alternatively, we may be eligible to transfer to The NASDAQ Capital Market in order to receive an additional 180 day grace period if we satisfy all of the requirements, other than the minimum bid price requirement, for listing on The NASDAQ Capital Market.
While we intend to engage in efforts to regain compliance, and thus maintain our listing, there can be no assurance that we will be able to regain compliance during the applicable time periods set forth above. If we fail to continue to meet all applicable NASDAQ Global Select Market requirements in the future and NASDAQ determines to delist our common stock, the delisting could substantially decrease trading in our common stock and adversely affect the market liquidity of our common stock; adversely affect our ability to obtain financing on acceptable terms, if at all, to continue our operations; and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. Additionally, the market price of our common stock may decline further and stockholders may lose some or all of their investment. The closing bid price of our common stock on the NASDAQ Global Select Market was $0.35 per share on October 30, 2015.
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
Unregistered Sales of Equity Securities
None
Issuer Purchases of Equity Securities
Under the terms of our Amended and Restated 2005 Employee, Director and Consultant Stock Plan, or the 2005 Plan, we may award shares of restricted stock to our employees, directors and consultants. These shares of restricted stock are subject to a lapsing right of repurchase by us. We may exercise this right of repurchase in the event that a restricted stock recipient’s employment, directorship or consulting relationship with us terminates prior to the end of the vesting period. If we exercise this right, we are required to repay the purchase price paid by or on behalf of the recipient for the repurchased restricted shares. Repurchased shares are returned to the 2005 Plan and are available for future awards under the terms of the 2005 Plan. |
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Period | Total Number of Shares Purchased | | Average Price Paid per Share | | Total Number of Shares Purchased as part of Publicly Announced Plans or Programs | | Maximum Number of Shares That May Yet Be Purchased Under the Plans or Programs |
July 1, 2015 through July 31, 2015 | — |
| | $ | — |
| | — |
| | — |
|
August 1, 2015 through August 31, 2015 | — |
| | $ | — |
| | — |
| | — |
|
September 1, 2015 through September 30, 2015 | — |
| | $ | — |
| | — |
| | — |
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(1) | Not included in the table above are 547 shares of common stock forfeited and retired in connection with the payment of minimum statutory withholding taxes due upon the vesting of certain stock awards or the exercise of certain stock options. In lieu of making a cash payment with respect to such withholding taxes, the holders of such stock forfeited a number of shares at the then current fair market value of the shares to pay such taxes. |
__________________________
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Exhibit Number | Exhibit Description |
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10.1† | Second Amendment to the Amended and Restated Credit, Security and Guaranty Agreement, dated July 10, 2015, with MidCap Funding IV Trust, as a lender and other lenders from time to time a party thereto, which is incorporated by reference to Exhibit 10.1 to the Registant's Quarterly Report on Form 10-Q filed on November 3, 2015. |
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10.2 | First Amendment to the Facility Agreement, dated July 10, 2015, by and among Alphatec Holdings, Inc., Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., and Deerfield Special Situations Fund, L.P., which is incorporated by reference to Exhibit 10.2 to the Registant's Quarterly Report on Form 10-Q filed on November 3, 2015. |
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10.3 | Amended and Restated Term Loan Note, dated July 10, 2015, with MidCap Funding IV Trust, which is incorporated by reference to Exhibit 10.3 to the Registant's Quarterly Report on Form 10-Q filed on November 3, 2015. |
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31.1 | Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 | Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32 | Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101 | The following materials from the Alphatec Holdings, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as (Unaudited) of September 30, 2015 and December 31, 2014, (ii) Condensed Consolidated Statements of Operations (Unaudited) for the three and nine months ended September 30, 2015 and 2014, (iii) Condensed Consolidated Statements of Comprehensive Loss (Unaudited) for the three and nine months ended September 30, 2015 and 2014, (iv) Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2015 and 2014, and (v) Notes to Condensed Consolidated Financial Statements (Unaudited). |
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† | Confidential treatment has been requested from the Securities and Exchange Commission as to certain portions of this document. |
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/ James M. Corbett |
| James M. Corbett President and Chief Executive Officer (principal executive officer) |
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By: | /s/ Michael O’Neill |
| Michael O’Neill Chief Financial Officer, Vice President and Treasurer (principal financial officer and principal accounting officer) |
Date: February 9, 2016
Exhibit Index
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Exhibit Number | Exhibit Description |
| |
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10.1† | Second Amendment to the Amended and Restated Credit, Security and Guaranty Agreement, dated July 10, 2015, with MidCap Funding IV Trust, as a lender and other lenders from time to time a party thereto, which is incorporated by reference to Exhibit 10.1 to the Registant's Quarterly Report on Form 10-Q filed on November 3, 2015. |
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10.2 | First Amendment to the Facility Agreement, dated July 10, 2015, by and among Alphatec Holdings, Inc., Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., and Deerfield Special Situations Fund, L.P., which is incorporated by reference to Exhibit 10.2 to the Registant's Quarterly Report on Form 10-Q filed on November 3, 2015. |
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10.3 | Amended and Restated Term Loan Note, dated July 10, 2015, with MidCap Funding IV Trust, which is incorporated by reference to Exhibit 10.3 to the Registant's Quarterly Report on Form 10-Q filed on November 3, 2015. |
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31.1 | Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 | Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32 | Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101 | The following materials from the Alphatec Holdings, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as (Unaudited) of September 30, 2015 and December 31, 2014, (ii) Condensed Consolidated Statements of Operations (Unaudited) for the three and nine months ended September 30, 2015 and 2014, (iii) Condensed Consolidated Statements of Comprehensive Loss (Unaudited) for the three and nine months ended September 30, 2015 and 2014, (iv) Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2015 and 2014, and (v) Notes to Condensed Consolidated Financial Statements (Unaudited). |
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† | Confidential treatment has been requested from the Securities and Exchange Commission as to certain portions of this document. |
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James M. Corbett, certify that:
1.I have reviewed this Amendment No. 1 to Quarterly Report on Form 10-Q of Alphatec Holdings, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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By: | /s/ James M. Corbett |
| James M. Corbett President and Chief Executive Officer (principal executive officer) |
| February 9, 2016 |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael O'Neill, certify that:
1.I have reviewed this Amendment No. 1 to Quarterly Report on Form 10-Q of Alphatec Holdings, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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By: | /s/ Michael O’Neill |
| Michael O’Neill Chief Financial Officer, Vice President and Treasurer (principal financial officer and principal accounting officer of the Company) |
| February 9, 2016 |
Exhibit 32
CERTIFICATION UNDER
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with Amendment No.1 to the Quarterly Report of Alphatec Holdings, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James M. Corbett, Chief Executive Officer, certify, to my knowledge, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
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1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
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2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
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Dated: | February 9, 2016 | /s/ James M. Corbett |
| | James M. Corbett President and Chief Executive Officer (principal executive officer) |
In connection with Amendment No.1 to the Quarterly Report of Alphatec Holdings, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael O’Neill, Chief Financial Officer, certify, to my knowledge, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
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1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
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2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
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Dated: | February 9, 2016 | /s/ Michael O’Neill |
| | Michael O’Neill Chief Financial Officer, Vice President and Treasurer (principal financial officer and principal accounting officer of the Company) |
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v3.3.1.900
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands |
Sep. 30, 2015 |
Dec. 31, 2014 |
Current assets: |
|
|
Cash |
$ 10,502
|
$ 19,735
|
Restricted cash |
3,450
|
4,400
|
Accounts receivable, net |
36,252
|
40,440
|
Inventories, net |
42,328
|
41,747
|
Prepaid expenses and other current assets |
5,225
|
5,466
|
Deferred income tax assets |
2,518
|
1,324
|
Total current assets |
100,275
|
113,112
|
Property and equipment, net |
23,720
|
26,040
|
Goodwill |
0
|
171,333
|
Intangibles, net |
22,943
|
30,259
|
Other assets |
1,446
|
4,179
|
Total assets |
148,384
|
344,923
|
Current liabilities: |
|
|
Accounts payable |
10,827
|
10,130
|
Accrued expenses |
27,216
|
35,393
|
Deferred revenue |
831
|
1,300
|
Common stock warrant liabilities |
687
|
8,702
|
Current portion of long-term debt |
79,300
|
8,076
|
Total current liabilities |
118,814
|
63,601
|
Long-term debt, less current portion |
700
|
74,597
|
Other long-term liabilities |
29,814
|
32,220
|
Deferred income tax liabilities |
1,623
|
1,948
|
Redeemable preferred stock, $0.0001 par value; 20,000 authorized at September 30, 2015 and December 31, 2014; 3,319 shares issued and outstanding at both September 30, 2015 and December 31, 2014 |
23,603
|
23,603
|
Stockholders’ (deficit) equity: |
|
|
Common stock, $0.0001 par value; 200,000 authorized at September 30, 2015 and December 31, 2014; 100,144 and 99,856 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively |
10
|
10
|
Treasury stock, at cost, 19 shares, at both September 30, 2015 and December 31, 2014 |
(97)
|
(97)
|
Additional paid-in capital |
416,620
|
413,921
|
Shareholder note receivable |
(5,000)
|
(5,000)
|
Accumulated other comprehensive loss |
(20,350)
|
(11,316)
|
Accumulated deficit |
(417,337)
|
(248,564)
|
Total stockholders’ (deficit) equity |
(26,154)
|
148,954
|
Total liabilities and stockholders’ (deficit) equity |
$ 148,384
|
$ 344,923
|
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v3.3.1.900
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
|
Sep. 30, 2015 |
Dec. 31, 2014 |
Statement of Financial Position [Abstract] |
|
|
Redeemable preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Redeemable preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Redeemable preferred stock, shares issued |
3,319,000
|
3,319,000
|
Redeemable preferred stock, shares outstanding |
3,319,000
|
3,319,000
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares issued |
100,144,000
|
99,856,000
|
Common stock, shares outstanding |
100,144,000
|
99,856,000
|
Treasury stock, shares |
19,000
|
19,000
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.3.1.900
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2015 |
Sep. 30, 2014 |
Sep. 30, 2015 |
Sep. 30, 2014 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
$ 42,996
|
$ 51,013
|
$ 138,276
|
$ 153,353
|
Cost of revenues |
14,154
|
14,272
|
48,234
|
46,305
|
Amortization of acquired intangible assets |
363
|
435
|
1,093
|
1,328
|
Gross profit |
28,479
|
36,306
|
88,949
|
105,720
|
Operating expenses: |
|
|
|
|
Research and development |
1,898
|
4,423
|
9,661
|
13,138
|
In-process research and development |
274
|
527
|
274
|
527
|
Sales and marketing |
17,134
|
18,649
|
51,973
|
56,545
|
General and administrative |
8,094
|
10,213
|
26,473
|
33,676
|
Amortization of acquired intangible assets |
521
|
742
|
1,867
|
2,257
|
Goodwill and intangible impairment |
165,171
|
0
|
165,171
|
0
|
Restructuring expenses |
335
|
20
|
163
|
706
|
Total operating expenses |
193,427
|
34,574
|
255,582
|
106,849
|
Operating income (loss) |
(164,948)
|
1,732
|
(166,633)
|
(1,129)
|
Other income (expense): |
|
|
|
|
Interest income |
18
|
2
|
37
|
8
|
Interest expense |
(3,110)
|
(3,875)
|
(9,521)
|
(9,310)
|
Other income (expense), net |
6,058
|
(928)
|
6,782
|
(1,230)
|
Total other income (expense) |
2,966
|
(4,801)
|
(2,702)
|
(10,532)
|
Pretax net loss |
(161,982)
|
(3,069)
|
(169,335)
|
(11,661)
|
Income tax (benefit) provision |
(1,717)
|
(28)
|
(562)
|
948
|
Net loss |
$ (160,265)
|
$ (3,041)
|
$ (168,773)
|
$ (12,609)
|
Net loss per basic share |
$ (1.61)
|
$ (0.03)
|
$ (1.70)
|
$ (0.13)
|
Net loss per diluted share |
$ (1.61)
|
$ (0.04)
|
$ (1.70)
|
$ (0.13)
|
Shares used in calculating basic net loss per share |
99,376
|
97,391
|
99,258
|
97,040
|
Shares used in calculating diluted net loss per share |
99,376
|
98,329
|
99,258
|
97,258
|
X |
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v3.3.1.900
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2015 |
Sep. 30, 2014 |
Sep. 30, 2015 |
Sep. 30, 2014 |
Statement of Comprehensive Income [Abstract] |
|
|
|
|
Net loss |
$ (160,265)
|
$ (3,041)
|
$ (168,773)
|
$ (12,609)
|
Foreign currency translation adjustments |
624
|
(9,093)
|
(9,034)
|
(9,815)
|
Comprehensive loss |
$ (159,641)
|
$ (12,134)
|
$ (177,807)
|
$ (22,424)
|
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v3.3.1.900
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2015 |
Sep. 30, 2014 |
Operating activities: |
|
|
Net loss |
$ (168,773)
|
$ (12,609)
|
Adjustments to reconcile net loss to net cash provided by (used in) by operating activities: |
|
|
Depreciation and amortization |
14,099
|
14,006
|
Stock-based compensation |
2,440
|
3,641
|
Interest expense related to amortization of debt discount and debt issuance costs |
3,630
|
4,354
|
Goodwill and intangible impairment |
165,171
|
0
|
Provision for doubtful accounts |
465
|
443
|
Provision for excess and obsolete inventory |
1,529
|
2,553
|
Deferred income tax expense |
(1,320)
|
338
|
Non-cash in-process research and development expenses |
98
|
102
|
Other non-cash items |
(4,983)
|
2,655
|
Changes in operating assets and liabilities: |
|
|
Restricted cash |
3,300
|
(2,001)
|
Accounts receivable |
3,475
|
373
|
Inventories |
(2,202)
|
(3,134)
|
Prepaid expenses and other current assets |
1,871
|
4,143
|
Other assets |
15
|
(202)
|
Accounts payable |
(277)
|
(261)
|
Accrued expenses and other |
(12,644)
|
(34,684)
|
Deferred revenues |
(328)
|
(1)
|
Net cash provided by (used in) operating activities |
5,566
|
(20,284)
|
Investing activities: |
|
|
Purchases of property and equipment |
(8,738)
|
(7,751)
|
Cash received from sale of assets |
0
|
300
|
Net cash used in investing activities |
(8,738)
|
(7,451)
|
Financing activities: |
|
|
Borrowings under lines of credit |
105,523
|
122,066
|
Repayments under lines of credit |
(110,354)
|
(115,068)
|
Principal payments on capital lease obligations |
(555)
|
(605)
|
Proceeds from notes payable |
5,000
|
24,500
|
Principal payments on notes payable |
(6,163)
|
(3,836)
|
Net cash (used in) provided by financing activities |
(6,549)
|
27,057
|
Effect of exchange rate changes on cash |
488
|
(498)
|
Net decrease in cash |
(9,233)
|
(1,176)
|
Cash at beginning of period |
19,735
|
21,345
|
Cash at end of period |
10,502
|
20,169
|
Supplemental disclosure of cash flow information: |
|
|
Cash paid for interest |
5,677
|
4,074
|
Cash paid for income taxes |
580
|
487
|
Purchases of property and equipment in accounts payable |
2,458
|
2,217
|
Non-cash debt discount |
0
|
500
|
Initial fair value of warrant liability |
0
|
10,368
|
Purchase of property and equipment through capital lease |
$ 243
|
$ 759
|
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v3.3.1.900
The Company and Basis of Presentation
|
9 Months Ended |
Sep. 30, 2015 |
Accounting Policies [Abstract] |
|
The Company and Basis of Presentation |
The Company and Basis of Presentation The Company Alphatec Holdings, Inc., through its wholly owned subsidiary, Alphatec Spine, Inc. and its subsidiaries (“Alphatec Spine”), designs, develops, manufactures and markets products for the surgical treatment of spine disorders. In addition to its U.S. operations, the Company also markets its products in over 50 international markets through the distribution channels of Alphatec Spine and its affiliate, Scient’x S.A.S., and its subsidiaries (“Scient’x”), via a direct sales force in Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa. In South America and Latin America, the Company conducts its operations through its Brazilian subsidiary, Cibramed Productos Medicos. In Japan, the Company markets its products through its subsidiary, Alphatec Pacific, Inc. and its subsidiaries (“Alphatec Pacific”). Basis of Presentation The accompanying condensed consolidated balance sheet as of December 31, 2014, 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 interim unaudited 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 financial statements for the year ended December 31, 2014, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 that was filed with the SEC on February 26, 2015. Operating results for the three and nine months ended September 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015, or any other future periods. The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through revenues from the sale of its products, equity financings and debt financings. As the Company has incurred losses, successful transition to profitability is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. This may not occur and, unless and until it does, the Company will continue to need to raise additional capital. The accompanying Condensed Consolidated Financial Statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. A going concern basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of its liabilities in the normal course of business. Operating losses and negative cash flows may continue for at least the next year as the Company continues to incur costs related to the execution of its operating plan, introduction of new products and expansion into new geographies. The Company's amended and restated credit facility (the "Amended Credit Facility") with MidCap Financial, LLC ("MidCap") matures in August 2016, which will require the Company to refinance the Amended Credit Facility with MidCap or to seek alternative financing. Management intends to pursue additional opportunities to raise additional capital through public or private equity offerings, debt financings, receivables financings or collaborations or partnerships with other companies to further support its planned operations. However, there is no assurance that it will be able to do so. Restatement of Condensed Consolidated Financial Statements The Company has determined that it failed to comply with the fixed charge coverage ratio covenant under its Amended Credit Facility with MidCap for June, August and September of 2015. The Company’s default under the MidCap credit facility also constitutes an event of default under the Facility Agreement with Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., Deerfield Special Situations Fund, L.P., and Deerfield Special Situations International Master Fund, L.P., (collectively "Deerfield"). In January and February of 2016, MidCap and Deerfield provided a waiver of the Company’s failure to comply with the covenant during such periods. The Company can provide no assurance that it will be in compliance with the financial covenants in the future. As a result of these events of default, the Company has determined to restate the condensed consolidated balance sheet as of September 30, 2015 to classify the amounts due under the Deerfield Facility Agreement as current portion of long-term debt, rather than long-term debt, less current portion. As a result of this error correction, the current portion of the long-term debt increased from $59.0 million as previously reported to $79.3 million and the amount of long-term debt less current portion decreased from$20.9 million as previously reported to $0.7 million. This correction had no effect on the other condensed consolidated financial statements included in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 that was filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2015.
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v3.3.1.900
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2015 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
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, 2014, which are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on February 26, 2015. Except as discussed below, these accounting policies have not significantly changed during the nine months ended September 30, 2015. Goodwill The Company accounts for goodwill in accordance with authoritative guidance which requires that goodwill be tested for impairment at least annually. The Company tests goodwill for impairment as of December 31 of each year, or more frequently if events and circumstances warrant. These assets are impaired if the Company determines that their carrying values may not be recoverable based on an assessment of certain events or changes in circumstances. If the assets are considered to be impaired, the Company recognizes the amount by which the carrying value of the assets exceeds the fair value of the assets as an impairment loss. In the third quarter of 2015, the market value of the Company’s common stock substantially declined. As a result of this decline, the Company determined that it had an indicator of impairment of its goodwill, and an interim test of goodwill impairment was required. As a result, the Company reviewed its goodwill for impairment under a two-part test in accordance with authoritative guidance. The Company estimated the fair value in step one of the goodwill impairment test based on a combination of the income approach which included discounted cash flows as well as a market approach that utilized the guideline company market information. The fair value measurements utilized to perform the impairment analysis are categorized within Level 3 of the fair value hierarchy. The Company’s discounted cash flows required management judgment with respect to forecasted sales, launch of new products, gross margin, selling, general and administrative expenses, capital expenditures and the selection and use of an appropriate discount rate and terminal rate. For purposes of calculating the discounted cash flows, the Company used estimated revenue growth rates between 3% and 13% for the discrete forecast period. Cash flows beyond the discrete forecast period were estimated using a terminal value calculation, which incorporated historical and forecasted financial trends and considered long-term earnings growth rates for publicly traded peer companies. Future cash flows were then discounted to present value at a discount rate of 13.5%, and terminal value growth rate of 3%. The Company's market capitalization was also considered in assessing the reasonableness of the Company’s fair value as determined in step one of the goodwill impairment test. The Company’s assessment resulted in a fair value that was lower than the Company’s carrying value of net assets at September 30, 2015. Based upon step one of the test, the Company determined that its goodwill was impaired and that step two of the test was required to measure the amount of goodwill impairment. As a result of step two, in the third quarter of 2015 the Company recorded a charge of $164.3 million, representing the write-off of the remaining balance of goodwill. Due to the length of time necessary to measure impairment of goodwill, the goodwill impairment analysis was not completed as of the time of the filing of this Quarterly Report on Form 10-Q and is subject to change. The Company expects to complete the step two impairment analysis prior to reporting its financial results for the fourth quarter of 2015 and will record any adjustments to this preliminary estimate at that time. 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 instruments that are considered to be Level 1 or Level 2 instruments as of September 30, 2015 or December 31, 2014. The Company classifies its common stock warrant liabilities within Level 3 of the fair value hierarchy because they are valued using valuation models with significant unobservable inputs. The following table provides a reconciliation of liabilities measured at fair value using significant unobservable inputs (Level 3) for the nine months ended September 30, 2015 (in thousands): | | | | | | Common Stock Warrant Liabilities | Balance at December 31, 2014 | $ | 8,702 |
| Changes in fair value | (8,015 | ) | Balance at September 30, 2015 | $ | 687 |
|
Common stock warrant liabilities are measured at fair value using the Black-Scholes option pricing valuation model. The assumptions used in the Black-Scholes option pricing valuation model for the common stock warrant liabilities were: (a) a risk-free interest rate based on the rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the remaining contractual term of the warrants; (b) an assumed dividend yield of zero based on the Company’s expectation that it will not pay dividends in the foreseeable future; (c) an expected term based on the remaining contractual term of the warrants; and (d) an expected volatility based upon the Company's historical volatility over the remaining contractual term of the warrants. The significant unobservable input used in measuring the fair value of the common stock warrant liabilities associated with the Deerfield Facility Agreement (described in Note 5 below) is the expected volatility. Significant increases in volatility would result in a higher fair value measurement. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board ("FASB") issued new accounting guidance related to revenue recognition. This new standard will replace all current U.S. GAAP guidance on this topic and eliminate all industry-specific guidance. The new revenue recognition standard provides a unified model to determine when and how revenue is recognized. The core principle is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. On August 12, 2015, the FASB issued guidance deferring the effective date by one year to December 15, 2017 for annual reporting periods beginning after that date. The FASB also permitted early adoption of the standard, but not before the original effective date of December 15, 2016. The Company is currently evaluating the impact, if any, the adoption of this standard will have on its financial statements. In August 2014, the FASB issued guidance related to disclosures of uncertainties about an entity’s ability to continue as a going concern. The guidance requires management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued. Management will be required to make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. Substantial doubt exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. The guidance is effective for annual periods ending after December 15, 2016 and for interim reporting periods within annual periods beginning after December 15, 2016, with early adoption permitted. The Company is currently evaluating the impact of this guidance and expects to adopt the standard for the annual reporting period ending December 31, 2016. In April 2015, the FASB issued guidance that amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. The guidance will not change the amortization of debt issuance costs, which will continue to follow the existing accounting guidance. The guidance is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. The Company is currently evaluating the impact of adopting this new accounting standard on its financial statements.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.3.1.900
Select Balance Sheet Details
|
9 Months Ended |
Sep. 30, 2015 |
Balance Sheet Related Disclosures [Abstract] |
|
Select Balance Sheet Details |
Select Balance Sheet Details Accounts Receivable, net Accounts receivable, net consist of the following (in thousands): | | | | | | | | | | September 30, 2015 | | December 31, 2014 | Accounts receivable | $ | 37,298 |
| | $ | 41,233 |
| Allowance for doubtful accounts | (1,046 | ) | | (793 | ) | Accounts receivable, net | $ | 36,252 |
| | $ | 40,440 |
|
Inventories, net Inventories, net consist of the following (in thousands) | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2015 | | December 31, 2014 | | Gross | | Reserve for excess and obsolete | | Net | | Gross | | Reserve for excess and obsolete | | Net | Raw materials | $ | 6,449 |
| | $ | — |
| | $ | 6,449 |
| | $ | 5,020 |
| | $ | — |
| | $ | 5,020 |
| Work-in-process | 1,898 |
| | — |
| | 1,898 |
| | 1,032 |
| | — |
| | 1,032 |
| Finished goods | 53,930 |
| | (19,949 | ) | | 33,981 |
| | 57,020 |
| | (21,325 | ) | | 35,695 |
| Inventories | $ | 62,277 |
| | $ | (19,949 | ) | | $ | 42,328 |
| | $ | 63,072 |
| | $ | (21,325 | ) | | $ | 41,747 |
|
Property and Equipment, net Property and equipment, net consist of the following (in thousands except as indicated): | | | | | | | | | | | | Useful lives (in years) | | September 30, 2015 | | December 31, 2014 | Surgical instruments | 4 | | $ | 64,838 |
| | $ | 62,872 |
| Machinery and equipment | 7 | | 15,585 |
| | 15,382 |
| Computer equipment | 3 | | 3,700 |
| | 3,180 |
| Office furniture and equipment | 5 | | 3,752 |
| | 3,789 |
| Leasehold improvements | various | | 3,854 |
| | 3,841 |
| Building | 39 | | 66 |
| | 65 |
| Land | n/a | | 9 |
| | 9 |
| Construction in progress | n/a | | 468 |
| | 1,320 |
| | | | 92,272 |
| | 90,458 |
| Less accumulated depreciation and amortization | | | (68,552 | ) | | (64,418 | ) | Property and equipment, net | | | $ | 23,720 |
| | $ | 26,040 |
|
Total depreciation expense was $3.4 million and $2.9 million for the three months ended September 30, 2015 and 2014, respectively. Total depreciation expense was $9.1 million and $9.2 million for the nine months ended September 30, 2015 and 2014, respectively. At September 30, 2015, assets recorded under capital leases of $3.2 million were included in the machinery and equipment balance and $0.2 million were included in the construction in progress balance. At December 31, 2014, assets recorded under capital leases of $3.2 million were included in the machinery and equipment balance and $0.6 million were included in the construction in progress balance. Amortization of assets under capital leases was included in depreciation expense. Intangible Assets, net Intangible assets, net consist of the following (in thousands except for useful lives): | | | | | | | | | | | | Useful lives (in years) | | September 30, 2015 | | December 31, 2014 | Developed product technology | 3-8 | | $ | 21,825 |
| | $ | 22,526 |
| Distribution rights | 3 | | 2,100 |
| | 2,095 |
| Intellectual property | 5 | | 1,004 |
| | 1,004 |
| License agreements | 1-7 | | 16,716 |
| | 16,716 |
| Core technology | 10 | | 4,187 |
| | 4,554 |
| Trademarks and trade names | 3-9 | | 3,307 |
| | 3,559 |
| Customer-related | 12-15 | | 19,458 |
| | 20,493 |
| Distribution network | 10-12 | | 4,027 |
| | 4,027 |
| Physician education programs | 10 | | 2,575 |
| | 2,802 |
| Supply agreement | 10 | | 225 |
| | 225 |
| | | | 75,424 |
| | 78,001 |
| Less accumulated amortization | | | (52,481 | ) | | (47,742 | ) | Intangible assets, net | | | $ | 22,943 |
| | $ | 30,259 |
|
Total amortization expense was $1.1 million and $1.6 million for the three months ended September 30, 2015 and 2014, respectively. Total amortization expense was $5.0 million and $4.8 million for the nine months ended September 30, 2015 and 2014, respectively. On June 19, 2015, the Company entered into an exclusive distribution agreement with a third party to market a biologic product that would replace its existing NEXoss Synthetic Bone Graft (See Note 4). The Company expensed $0.3 million as an impairment charge in cost of goods sold in the nine months ended September 30, 2015 for the write-off of an intangible asset related to this product. Additionally, due to a revised marketing strategy for the Company's Epicage interbody fusion device, the Company evaluated the related intangible asset for impairment in June 2015. As a result of this impairment analysis the Company expensed $0.9 million as an impairment charge in cost of goods sold in the nine months ended September 30, 2015 for the write-off of an intangible asset related to this product. In connection with the step two goodwill impairment test (see Note 2) the Company determined that the physician education intangible acquired in the Scient’x acquisition was impaired. As a result, the Company expensed $0.9 million included in goodwill and intangible impairment in the three and nine months ended September 30, 2015. Prior to the impairment, amortization of the physician education intangible asset had been recorded in amortization of acquired intangible assets within operating expenses. Future amortization expense related to intangible assets as of September 30, 2015 is as follows (in thousands): | | | | | Year Ending December 31, | | Remainder of 2015 | $ | 1,036 |
| 2016 | 4,059 |
| 2017 | 4,053 |
| 2018 | 2,884 |
| 2019 | 2,441 |
| Thereafter | 8,470 |
| | $ | 22,943 |
|
Accrued Expenses Accrued expenses consist of the following (in thousands): | | | | | | | | | | September 30, 2015 | | December 31, 2014 | Legal | $ | 554 |
| | $ | 967 |
| Accounting | 1,017 |
| | 1,262 |
| Severance | 322 |
| | 318 |
| Restructuring | 137 |
| | 531 |
| Sales milestones | 133 |
| | 107 |
| Accrued taxes | 729 |
| | 1,344 |
| Deferred rent | 462 |
| | 785 |
| Royalties | 1,712 |
| | 2,129 |
| Commissions | 5,189 |
| | 6,152 |
| Payroll and related | 5,359 |
| | 8,291 |
| Litigation settlements | 4,400 |
| | 7,393 |
| Accrued interest | 1,017 |
| | 946 |
| Other | 6,185 |
| | 5,168 |
| Total accrued expenses | $ | 27,216 |
| | $ | 35,393 |
|
Goodwill The changes in the carrying amount of goodwill from December 31, 2014 through September 30, 2015 are as follows (in thousands): | | | | | | | Balance at December 31, 2014 | $ | 171,333 |
| Goodwill impairment | (164,266 | ) | Effect of foreign exchange rate on goodwill | (7,067 | ) | Balance at September 30, 2015 | $ | — |
|
In the third quarter of 2015, the market value of the Company’s common stock substantially declined. As a result of this decline, the Company determined that it had an indicator of impairment of its goodwill, and an interim test of goodwill impairment was required (See Note 2). As a result of this interim test, the Company recorded a charge of $164.3 million, representing the write-off of the balance of goodwill in the three and nine months ended September 30, 2015. Due to the length of time necessary to measure impairment of goodwill, the goodwill impairment analysis was not completed as of the time of the filing of this Quarterly Report on Form 10-Q and is subject to change. The Company expects to complete the step two impairment analysis prior to reporting its financial results for the fourth quarter of 2015 and will record any adjustments to this preliminary estimate at that time.
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v3.3.1.900
License and Consulting Agreements
|
9 Months Ended |
Sep. 30, 2015 |
Contractors [Abstract] |
|
License and Consulting Agreements |
License and Consulting Agreements The Company’s license and consulting agreements are described below and in Note 5 to its audited consolidated financial statements for the year ended December 31, 2014, which are included in its Annual Report on Form 10-K which was filed with the SEC on February 26, 2015. License Agreements In June 2015 the Company entered into an exclusive distribution agreement with a third party supplier pursuant to which the Company acquired exclusive worldwide distribution rights to market a synthetic biologic product under the Company's own brand name (the "Biologic Supply Agreement"). The Biologic Supply Agreement requires the Company to make minimum payments to the third party supplier for the Company's worldwide distribution rights under the agreement to remain exclusive. Asset Purchase Agreement In July 2014, the Company entered into an asset purchase and product development services agreement (the "Asset Purchase Agreement") whereby the Company purchased rights to the conceptual design for an intervertebral implant device. The financial terms of the Agreement include payments in cash and the Company's common stock upon achievement of various milestones. The Company treated this arrangement as an asset acquisition. In the three months ended September 30, 2014, the Company made cash payments totaling $0.2 million and issued 72,992 shares of the Company's common stock valued at $0.1 million. The Company recognized the cash and stock payments of $0.3 million as in-process research and development expense in the three and nine months ended September 30, 2014. Under the terms of the Asset Purchase Agreement, for milestones achieved in September 2015, the Company was obligated to pay $0.2 million cash compensation and issue 72,992 shares of the Company's common stocks valued at $0.1 million. The Company expensed $0.3 million as in-process research and development in the three and nine months ended September 30, 2015.
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- DefinitionThe entire disclosure for long-term contracts or programs.
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v3.3.1.900
Debt
|
9 Months Ended |
Sep. 30, 2015 |
Debt Disclosure [Abstract] |
|
Debt |
Debt MidCap Facility Agreement On August 30, 2013, the Company entered into the Amended Credit Facility with MidCap. The Amended Credit Facility amended and restated the prior credit facility that the Company had with MidCap (the "Prior Credit Facility"). Pursuant to the Amended Credit Facility, the Company increased the borrowing limit from $50 million to $73 million. The Company also extended the maturity of the credit facility to August 2016. In July 2015, the Company further amended the Amended Credit Facility to provide for an additional term loan of $5 million. As of September 30, 2015, the Amended Credit Facility consisted of a $38 million term loan, $28 million of which was drawn at closing and the remaining $5 million of which was drawn in April 2014, a $5 million term loan drawn in July 2015 and a revolving line of credit with a maximum borrowing base of $40 million, of which $27.0 million was outstanding under the revolving line of credit at September 30, 2015. The Company used the term loan proceeds of $28 million drawn at closing to repay a portion of the outstanding balance on the prior revolving line of credit. The term loan interest rate is priced at the London Interbank Offered Rate ("LIBOR") plus 8.0%, subject to a 9.5% floor, and the revolving line of credit interest rate remains priced at LIBOR plus 6.0%, reset monthly. At September 30, 2015, the revolving line of credit carried an interest rate of 6.2% and the term loan carries an interest rate of 9.5%. The borrowing base is determined, from time to time, based on the value of domestic eligible accounts receivable and domestic eligible inventory. As collateral for the Amended Credit Facility, the Company granted MidCap a security interest in substantially all of its assets, including all accounts receivable and all securities evidencing its interests in its subsidiaries. In addition to monthly payments of interest, monthly repayments of $0.5 million are due through maturity, with the remaining principal due upon maturity. In connection with the execution of the Amended Credit Facility, the Company incurred an additional $0.4 million in costs that were capitalized as debt issuance costs. At September 30, 2015, $0.3 million remains as unamortized debt issuance costs related to the prior and Amended Credit Facility within the unaudited consolidated balance sheet, which will be amortized over the remaining term of the Amended Credit Facility. The Amended Credit Facility includes traditional lending and reporting covenants including a fixed charge coverage ratio, a senior leverage ratio and a total leverage ratio to be maintained by the Company. The Amended Credit Facility also includes several event of default provisions, such as payment default and insolvency conditions, 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 MidCap’s right to declare all outstanding obligations immediately due and payable. In February 2013, the Company and MidCap entered into a first amendment to the Credit Facility (the "First Amendment to the Credit Facility”). The First Amendment to the Credit Facility allowed the Company to exclude payments related to an acquisition and a settlement agreement from calculation of the fixed charge coverage ratio and the senior leverage ratio. In conjunction with the First Amendment to the Credit Facility, the Company paid MidCap a fee of $0.1 million. On March 17, 2014, the Company entered into a first amendment to the Amended Credit Facility with MidCap (the "First Amendment to the Amended Credit Facility"). Under the First Amendment to the Amended Credit Facility, MidCap gave the Company its consent to enter into the Facility Agreement (defined below) and make settlement payments in connection with the Orthotec litigation. The First Amendment to the Amended Credit Facility also added a total leverage ratio financial covenant. On July 10, 2015, the Company entered into a Second Amendment to the Amended Credit Facility with MidCap (the "Second Amendment to the Amended Credit Facility") to increase the term loan commitment from $33 million to $38 million. The Company borrowed the additional $5 million under the term loan on July 10, 2015, which is the third term loan tranche under the Amended Credit Facility (the "Third Term Loan Tranche"). Until January 1, 2016, only interest payments are due for the Third Term Loan Tranche. Thereafter, the Company will pay an amount equal to $0.5 million on the first day of each calendar month as an amortization payment in respect of all tranches of the term loan. The Company paid MidCap, a commitment fee equal to 1.0% of the principal amount of the funds disbursed in the Third Term Loan Tranche. The Company was in compliance with all of the covenants of the Amended Credit Facility as of September 30, 2015, except for the non-compliance disclosed in Note 1. The Company has obtained waivers in January and February of 2016 from MidCap to cure the breach of the fixed charge coverage ratio covenant for each of June, August and September of 2015. There is not assurance that the Company will be in compliance with the financial covenants of the Amended Credit Facility in the future. Deerfield Facility Agreement On March 17, 2014, the Company entered into the facility agreement with Deerfield (the "Facility Agreement"), pursuant to which Deerfield agreed to loan the Company up to $50 million, subject to the terms and conditions set forth in the Facility Agreement. Under the terms of the Facility Agreement, the Company had the option, but was not required, upon certain conditions to draw the entire amount available under the Facility Agreement, at any time until January 30, 2015 (the “Draw Period”), provided that the initial draw be used for a portion of the payments made in connection with the Orthotec settlement described in Note 7 below. The Company agreed to pay Deerfield, upon each disbursement of funds under the Facility Agreement, a transaction fee equal to 2.5% of the principal amount of the funds disbursed. Amounts borrowed under the Facility Agreement bear interest at a rate of 8.75% per annum and are payable on the third, fourth and fifth anniversary date of the first amount borrowed under the Facility Agreement, with the final payment due on March 20, 2019. The Facility Agreement also contains various representations and warranties, and affirmative and negative covenants, customary for financings of this type, including restrictions on the ability of the Company and its subsidiaries to incur additional indebtedness or liens on its assets, except as permitted under the Facility Agreement. As security for the Company's repayment of its obligations under the Facility Agreement, the Company granted to Deerfield a security interest in substantially all of the Company's property and interests in property, which is subordinated to the security interest granted under the Amended Credit Facility. In connection with the execution of the Facility Agreement on March 17, 2014, the Company issued to Deerfield warrants to purchase an aggregate of 6,250,000 shares of the Company’s common stock, which are immediately exercisable and have an exercise price equal to $1.39 per share (the “Initial Warrants”). Additionally, the Company agreed that each disbursement borrowing under the Facility Agreement be accompanied by the issuance to Deerfield of warrants to purchase up to 10,000,000 shares of the Company’s common stock, in proportion to the amount of draw compared to the total $50 million facility (the "Draw Warrants"). On March 20, 2014, the Company made an initial draw of $20 million under the Facility Agreement and received net proceeds of $19.5 million to fund the portion of the settlement payment obligations that were due in 2014 to Orthotec, LLC. The $0.5 million transaction fee is recorded as a debt discount and is being amortized over the term of the draw, which ends March 20, 2019. In connection with this borrowing, the Company issued Draw Warrants to purchase 4,000,000 shares of common stock at an exercise price of $1.39 per share, which were valued at $4.7 million and recorded as a debt discount, which is being amortized over the term of the $20 million draw. Additionally, $2.3 million of the value of the Initial Warrants was reclassified as a debt discount and is being amortized through interest expense over the term of the debt using the effective interest method. On November 21, 2014, the Company made a second draw of $6.0 million under the Facility Agreement and received net proceeds of $5.9 million to fund a portion of the Orthotec settlement payments due through 2016. The $0.2 million transaction fee was recorded as a debt discount and is being amortized over the remaining term of the draw, which ends March 20, 2019. In connection with this second draw, the Company issued Draw Warrants to purchase 1,200,000 shares of common stock at an exercise price of $1.39 per share, which were valued at $0.9 million and were recorded as a debt discount, which is being amortized over the term of the debt using the effective interest method. Additionally, $0.2 million of the value of the Initial Warrants was reclassified as a debt discount and is being amortized through interest expense over the term of the debt using the effective interest method. No amounts remain available for the Company to borrow under the Facility Agreement. As of September 30, 2015, Orthotec settlement payments of $21.9 million have been made, leaving remaining proceeds from the funds borrowed under the Facility Agreement of $3.5 million, which was classified as short-term restricted cash, as its use is limited under the terms of the Facility Agreement for the payments of amounts due under the Orthotec litigation settlement agreement. Additionally, a payment of $1.1 million was made on October 1, 2015. The amounts borrowed under the Facility Agreement, which total $26.0 million in principal as of September 30, 2015, are due in three equal annual payments beginning March 20, 2017. As a result of the Company's non-compliance with the MidCap fixed charge coverage ratio covenant, the Company was in cross-default of the Facility Agreement, for which the Company received a waiver from Deerfield in February 2016 for the months of June, August and September 2015. There is no assurance that the Company will be in compliance with the financial covenants of the Amended Credit Facility in the foreseeable future, which would result in cross-default under the Facility Agreement in which case Deerfield would have the right to call the debt outstanding under the Facility Agreement due immediately. Accordingly, as disclosed in Note 1, the amounts borrowed under the Facility Agreement are presented on the condensed consolidated balance sheet as of September 30, 2015 under current liabilities, net of unamortized issuance discount. As of September 30, 2015, the outstanding Initial Warrants and Draw Warrants to purchase an aggregate of 11,450,000 shares of common stock were revalued to their fair value with a charge to other income expense of $6.3 million and $8.0 million for the three months and nine months ended September 30, 2015, respectively. The change in the fair value of the warrants of $8.0 million for the nine months ended September 30, 2015 is included in other non-cash items in the condensed consolidated statements of cash flow. The warrant liability of $0.7 million is recorded as common stock warrant liabilities within current liabilities on the condensed consolidated balance sheet as of September 30, 2015. On July 10, 2015, the Company entered into a First Amendment to the Facility Agreement (the “Facility Agreement First Amendment”), with Deerfield. The Facility Agreement First Amendment permitted, among other things, the Company to enter into and borrow the additional $5 million under the term loan in July 2015 under the Second Amendment to the Amended Credit Facility. At September 30, 2015, the outstanding warrants were valued using the Black-Scholes option pricing model. This is a Level 3 measurement using the following assumptions: | | | | | September 30, 2015 | Risk-free interest rate | 1.3 | % | Dividend yield | — | % | Expected volatility | 63 | % | Expected life (years) | 4.5 |
|
Principal payments on debt are as follows as of September 30, 2015 (in thousands): | | | | | | | Year Ending December 31, | | Remainder of 2015 (1) | $ | 2,058 |
| 2016 (1) | 56,173 |
| 2017 (1) | 8,667 |
| 2018 (1) | 8,667 |
| 2019 (1) | 8,666 |
| Thereafter | — |
| Total | 84,231 |
| Add: capital lease principal payments | 1,471 |
| Less: debt discount | (5,765 | ) | Total | 79,937 |
| Less: current portion of long-term debt (1) | (79,253 | ) | Long-term debt, net of current portion | $ | 684 |
|
(1) The amounts above are presented based on the contractual payment schedules in each of the respective agreements. However, the debt balance under the Amended Credit Facility and the Facility Agreement was callable as of September 30, 2015 due to the event of default (See Note 1 and Note 5) and therefore, is presented as a current liability on the condensed consolidated balance sheet as of September 30, 2015.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.3.1.900
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2015 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Commitments and Contingencies Leases The Company leases certain equipment under capital leases which expire on various dates through September 2018. The leases bear interest at rates ranging from 6.6% to 9.6% per annum, are generally due in monthly principal and interest installments and are collateralized by the related equipment. The Company also leases its buildings and certain equipment and vehicles under operating leases which expire on various dates through January 2019. Future minimum annual lease payments under such leases are as follows as of September 30, 2015 (in thousands): | | | | | | | | | Year Ending December 31, | Operating | | Capital | Remainder of 2015 | $ | 899 |
| | $ | 224 |
| 2016 | 2,318 |
| | 877 |
| 2017 | 846 |
| | 437 |
| 2018 | 272 |
| | 68 |
| 2019 | 137 |
| | — |
| | $ | 4,472 |
| | 1,606 |
| Less: amount representing interest | | | (135 | ) | Present value of minimum lease payments | | | 1,471 |
| Current portion of capital leases | | | (799 | ) | Capital leases, less current portion | | | $ | 672 |
|
Rent expense under operating leases for the three months ended September 30, 2015 and 2014 was $0.8 million. Rent expense under operating leases for the nine months ended September 30, 2015 and 2014 was $2.3 million and $2.6 million, respectively. 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 our 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. 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 calculated either as a percentage of net sales or in one instance on a per-unit sold basis. Royalties are included on the accompanying condensed consolidated statement of operations as a component of cost of revenues.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.3.1.900
Orthotec Settlement
|
9 Months Ended |
Sep. 30, 2015 |
Commitments and Contingencies Disclosure [Abstract] |
|
Orthotec Settlement |
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 $49 million in cash, including initial cash payments totaling $1.75 million, which the Company previously paid in March 2014, and an additional lump sum payment of $15.75 million, which the Company previously paid in April 2014. The Company agreed to pay the remaining $31.5 million in 28 quarterly installments of $1.1 million and then one additional quarterly installment of $0.7 million, commencing October 1, 2014. As of September 30, 2015, the Company has made installment payments in the aggregate of $21.9 million. The Company has the right to prepay the amounts due without penalty. In addition, the unpaid balance of the amounts due accrues interest at the rate of 7% per year beginning May 15, 2014 until the amounts due are paid in full. The accrued but unpaid interest will be paid in quarterly installments of $1.1 million (or the full amount of the accrued but unpaid interest if less than $1.1 million) following the full payment of the $31.5 million in quarterly installments described above. No interest will accrue on the accrued interest. The Settlement Agreement provided for mutual releases of all claims in the Orthotec, LLC v. Surgiview, S.A.S, et al. matter in the Superior Court of California, Los Angeles County and all other related litigation matters involving the Company and its directors and affiliates.
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v3.3.1.900
Net Loss Per Share
|
9 Months Ended |
Sep. 30, 2015 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
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, options 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 (in thousands, except per share data): | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2015 | | 2014 | | 2015 | | 2014 | Numerator: | | | | | | | | Net loss for basic earnings per share | $ | (160,265 | ) | | $ | (3,041 | ) | | $ | (168,773 | ) | | $ | (12,609 | ) | Decrease in fair value of warrants | — |
| | (513 | ) | | — |
| | (520 | ) | Diluted net loss applicable to common stockholders | $ | (160,265 | ) | | $ | (3,554 | ) | | $ | (168,773 | ) | | $ | (13,129 | ) | Denominator: | | | | | | | | Weighted average common shares outstanding | 100,144 |
| | 98,126 |
| | 100,092 |
| | 97,864 |
| Weighted average unvested common shares subject to repurchase | (768 | ) | | (735 | ) | | (834 | ) | | (824 | ) | Weighted average common shares outstanding—basic | 99,376 |
| | 97,391 |
| | 99,258 |
| | 97,040 |
| Effect of dilutive securities: | | | | | | | | Conversion of preferred stock | — |
| | — |
| | — |
| | — |
| Options | — |
| | — |
| | — |
| | — |
| Warrants | — |
| | 938 |
| | — |
| | 218 |
| Weighted average common shares outstanding—diluted | 99,376 |
| | 98,329 |
| | 99,258 |
| | 97,258 |
| Net loss per share: | | | | | | | | Basic | $ | (1.61 | ) | | $ | (0.03 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) | Diluted | $ | (1.61 | ) | | $ | (0.04 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) |
The anti-dilutive securities not included in diluted net loss per share were as follows (in thousands): | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2015 | | 2014 | | 2015 | | 2014 | Options to purchase common stock | 7,859 |
| | 6,904 |
| | 8,029 |
| | 7,199 |
| Unvested restricted share awards | 768 |
| | 735 |
| | 834 |
| | 824 |
| Warrants to purchase common stock | 11,544 |
| | 594 |
| | 11,544 |
| | 6,844 |
| Total | 20,171 |
| | 8,233 |
| | 20,407 |
| | 14,867 |
|
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v3.3.1.900
Stock Benefit Plans and Stock-Based Compensation
|
9 Months Ended |
Sep. 30, 2015 |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] |
|
Stock Benefit Plans and Stock-Based Compensation |
Stock Benefit Plans and Stock-Based Compensation In February 2015, the Company granted 1,854,000 performance-based restricted stock units ("PSUs") to certain employees under its 2005 Employee, Director and Consultant Stock Plan (the "2005 Plan"). The PSUs vest based upon the Company's achievement of certain performance goals over the period from January 1, 2015 through December 31, 2017. The number of PSUs that may vest varies between 0%-200% based on the achievement of such goals. The PSUs were valued at $1.35 per share based on the closing price of the Company's common stock on the date of grant. For purposes of measuring compensation expense, the amount of PSUs ultimately expected to vest is estimated at each reporting date based on management’s expectations regarding the relevant performance criteria. The recognition of compensation expense associated with PSUs requires judgment in assessing the probability of meeting the performance goals, as well as defined criteria for assessing achievement of the performance-related goals. The awards are deemed probable of vesting as of September 30, 2015.
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- DefinitionThe entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details.
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v3.3.1.900
Income Taxes
|
9 Months Ended |
Sep. 30, 2015 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
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 as the tax environment changes. The Company recognizes interest and penalties related to uncertain tax positions as a component of the income tax provision. The Company’s unrecognized tax benefits decreased less than $0.2 million during the nine months ended September 30, 2015. The decrease in unrecognized tax benefits during the nine months ended September 30, 2015 was primarily related to foreign currency fluctuations and changes in prior year uncertain tax positions within the Company's foreign subsidiaries, partially offset by an increase related to state research credits and uncertain tax positions within the Company’s foreign subsidiaries. The unrecognized tax benefits at September 30, 2015 and December 31, 2014 were $8.7 million and $8.9 million, respectively. With the facts and circumstances currently available to the Company, it is reasonably possible that the amount that could reverse over the next 12 months is insignificant. Additionally, the French restructuring (see Note 12) may result in limitations on the Company’s ability to utilize its French net operating loss carryforwards to offset future taxable income. The income tax benefit consists primarily of the income tax benefit related to the reversal of the deferred tax liabilities associated with tax deductible goodwill, partially offset by income tax provisions related to state income taxes and operations in other foreign jurisdictions where the Company operates. The tax impact of the $165.2 million impairment charge (see note 2) in the current quarter is a $1.5 million income tax benefit as a result of the reversal of the deferred tax liabilities on the tax deductible goodwill due to the Company having a valuation allowance against deferred tax assets. The Company is not currently under examination by the Internal Revenue Service, or by any foreign, state or local tax authorities.
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v3.3.1.900
Segment and Geographical Information
|
9 Months Ended |
Sep. 30, 2015 |
Segment Reporting [Abstract] |
|
Segment and Geographical Information |
Segment and Geographical Information Operating segments are defined as components of an enterprise for which separate financial information is available and evaluated regularly by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company has one operating and one reportable business segment. During the three and nine months ended September 30, 2015 and 2014, the Company operated in two geographic regions, the U.S. and International, which consists of locations outside of the U.S. In the International geographic region, sales in Japan for the three and nine months ended September 30, 2015 totaled $8.3 million and $23.7 million, respectively, which represented greater than 10 percent of the Company’s consolidated revenues for such periods. In the International geographic region, sales in Japan for the three and nine months ended September 30, 2014 totaled $8.5 million and $23.8 million, respectively, which represented greater than 10 percent of the Company’s consolidated revenues for such periods. Revenues attributed to the geographic location of the customer were as follows (in thousands): | | | | | | | | | | | | | | | | | | Three Months Ended | | Nine Months Ended | | September 30, | | September 30, | | 2015 | | 2014 | | 2015 | | 2014 | United States | $ | 27,385 |
| | $ | 34,808 |
| | $ | 85,099 |
| | $ | 101,376 |
| International | 15,611 |
| | 16,205 |
| | 53,177 |
| | 51,977 |
| Total consolidated revenues | $ | 42,996 |
| | $ | 51,013 |
| | $ | 138,276 |
| | $ | 153,353 |
|
Total assets by region were as follows (in thousands): | | | | | | | | | | September 30, 2015 | | December 31, 2014 | United States | $ | 99,710 |
| | $ | 200,978 |
| International | 48,674 |
| | 143,945 |
| Total consolidated assets | $ | 148,384 |
| | $ | 344,923 |
|
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.3.1.900
Restructuring
|
9 Months Ended |
Sep. 30, 2015 |
Restructuring and Related Activities [Abstract] |
|
Restructuring |
Restructuring On September 16, 2013, the Company announced that Scient'x began a process to significantly restructure its business operations in France in an effort to improve operating efficiencies and rationalize its cost structure. The restructuring included a reduction in Scient'x's workforce and closing of the manufacturing facilities in France. The Company has recorded total costs of $10.3 million to date associated with this restructuring, which includes employee severance, social plan benefits and related taxes, facility closing costs, manufacturing transfer costs, and contract termination costs, in accordance with ASC Topic 420, Accounting for Costs Associated with Exit or Disposal Activities, and ASC Topic 712, Non Retirement Postemployment Benefits. The Company has substantially completed the activities associated with the Scient'x restructuring as of September 30, 2015, and substantially all of the costs have been paid. On July 6, 2015, the Company announced a restructuring of its manufacturing operations in California in an effort to improve its cost structure. The restructuring includes a reduction in workforce and closing the California manufacturing facility. Restructuring liabilities are measured at fair value and recognized as incurred. The restructuring will take place over the next year and the Company estimates that it will incur termination benefits, accelerated depreciation, facility closing and other restructuring costs of up to $4 million. Certain restructuring costs are based upon estimates. Actual amounts paid may ultimately be different from these estimates. If additional costs are incurred, such additional costs will be recognized when they occur.
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- DefinitionThe entire disclosure for restructuring and related activities. Description of restructuring activities such as exit and disposal activities, include facts and circumstances leading to the plan, the expected plan completion date, the major types of costs associated with the plan activities, total expected costs, the accrual balance at the end of the period, and the periods over which the remaining accrual will be settled.
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v3.3.1.900
Related Party Transactions
|
9 Months Ended |
Sep. 30, 2015 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
Related Party Transactions
For the nine months ended September 30, 2015 and 2014, the Company incurred expenses of $0.1 million related to HealthpointCapital, LLC. As of September 30, 2015, the Company also had a liability of $0.1 million payable to HealthpointCapital, LLC for travel and administrative expenses. The Company has entered into indemnification agreements with certain of its directors which are named defendants in the New York Orthotec matter (see Note 7 – Orthotec Settlement). The indemnification agreements require the Company to indemnify these individuals to the fullest extent permitted by applicable law and to advance expenses incurred by them in connection with any proceeding against them to which they may be entitled to indemnification by the Company. For the nine months ended September 30, 2015 and 2014, the Company incurred legal expenses of zero and less than $0.1 million, respectively, in connection with the Company’s indemnification obligations for two former directors of Scient'x in the New York Orthotec matter.
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.3.1.900
Subsequent Events
|
9 Months Ended |
Sep. 30, 2015 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Subsequent Event
On November 2, 2015, the Company entered into a first amendment (the "First Amendment") to the collaboration agreement with Elite Medical Holdings, LLC and Pac 3 Surgical Products, LLC (the "Collaborators") (the "Collaboration Agreement"). Under the Collaboration Agreement, the Collaborators agreed to provide services related to the development and commercialization of the Company’s current products and products in the Company’s product pipeline. As consideration for the services, the Collaboration Agreement provides that the Company will issue an aggregate $8.0 million of the Company’s common stock, based on a per share price of $1.95 per share, which was the average of the closing price of the Company’s common stock on The NASDAQ Global Select Market on each of the four days prior to the effective date and the effective of the Collaboration Agreement. Pursuant to the First Amendment, in exchange for a "lock up" restriction on selling or transferring each tranche of shares issued to the Collaborators and a maximum value cap (as discussed below), the Company has agreed to make a cash payment to the Collaborators in the event that the shares in such tranche do not have a minimum amount of value based on the market value of the Company’s common stock at the end of the lock up period applicable to such tranche of shares. In addition, in the event that at the end of a lock up period the value of a tranche of shares issued to the Collaborators exceeds a certain amount, the Collaborators have agreed to forfeit shares back to the Company, so as to limit the maximum amount of value derived from such shares at the end of a lock up period. Pursuant to the First Amendment, the shares issued to the Collaborators in each of 2014, 2015 and 2016 are subject to a lock up that lasts until the first quarter of 2017, 2018 and 2019, respectively. The valuation of each tranche of shares occurs at the end of the applicable lock up period. Based on the closing price of the Company’s common stock on October 30, 2015, the Company could have an additional liability of $3.5 million for shares of the Company’s common stock previously issued under the Collaboration Agreement, with $2.1 million payable in 2017 and $1.4 million million payable in 2018. In addition, based on the closing price of the Company’s common stock on October 30, 2015, the Company could have an additional liability of $2.8 million for shares of the Company’s common stock issuable under the remaining terms of the Collaboration Agreement (assuming that all of the shares issuable under the Collaboration Agreement are issued), with $0.7 million payable in 2018 (in addition to the amount above payable in 2018), and $2.1 million payable in 2019. If the Collaborators elect to sell, assign or transfer: (i) more than 20% of the shares issued to the Collaborators prior to the first valuation date; or (ii) any of the Collaborator shares still subject to a lockup after the first valuation date, all of the aforementioned restrictions on transfer and valuation minimums and maximums are null and void. Other than as set forth in the First Amendment, the Collaboration Agreement remains in full force and effect.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.3.1.900
The Company and Basis of Presentation The Company and Basis of Presentation (Policies)
|
9 Months Ended |
Sep. 30, 2015 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis of Presentation The accompanying condensed consolidated balance sheet as of December 31, 2014, 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 interim unaudited 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 financial statements for the year ended December 31, 2014, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 that was filed with the SEC on February 26, 2015.
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- DefinitionDisclosure of accounting policy for basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.3.1.900
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2015 |
Accounting Policies [Abstract] |
|
Goodwill |
Goodwill The Company accounts for goodwill in accordance with authoritative guidance which requires that goodwill be tested for impairment at least annually. The Company tests goodwill for impairment as of December 31 of each year, or more frequently if events and circumstances warrant. These assets are impaired if the Company determines that their carrying values may not be recoverable based on an assessment of certain events or changes in circumstances. If the assets are considered to be impaired, the Company recognizes the amount by which the carrying value of the assets exceeds the fair value of the assets as an impairment loss. In the third quarter of 2015, the market value of the Company’s common stock substantially declined. As a result of this decline, the Company determined that it had an indicator of impairment of its goodwill, and an interim test of goodwill impairment was required. As a result, the Company reviewed its goodwill for impairment under a two-part test in accordance with authoritative guidance. The Company estimated the fair value in step one of the goodwill impairment test based on a combination of the income approach which included discounted cash flows as well as a market approach that utilized the guideline company market information. The fair value measurements utilized to perform the impairment analysis are categorized within Level 3 of the fair value hierarchy. The Company’s discounted cash flows required management judgment with respect to forecasted sales, launch of new products, gross margin, selling, general and administrative expenses, capital expenditures and the selection and use of an appropriate discount rate and terminal rate. For purposes of calculating the discounted cash flows, the Company used estimated revenue growth rates between 3% and 13% for the discrete forecast period. Cash flows beyond the discrete forecast period were estimated using a terminal value calculation, which incorporated historical and forecasted financial trends and considered long-term earnings growth rates for publicly traded peer companies. Future cash flows were then discounted to present value at a discount rate of 13.5%, and terminal value growth rate of 3%. The Company's market capitalization was also considered in assessing the reasonableness of the Company’s fair value as determined in step one of the goodwill impairment test. The Company’s assessment resulted in a fair value that was lower than the Company’s carrying value of net assets at September 30, 2015. Based upon step one of the test, the Company determined that its goodwill was impaired and that step two of the test was required to measure the amount of goodwill impairment. As a result of step two, in the third quarter of 2015 the Company recorded a charge of $164.3 million, representing the write-off of the remaining balance of goodwill.
|
Fair Value Measurements |
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 instruments that are considered to be Level 1 or Level 2 instruments as of September 30, 2015 or December 31, 2014. The Company classifies its common stock warrant liabilities within Level 3 of the fair value hierarchy because they are valued using valuation models with significant unobservable inputs.
|
Warrants to Purchase Common Stock |
Common stock warrant liabilities are measured at fair value using the Black-Scholes option pricing valuation model. The assumptions used in the Black-Scholes option pricing valuation model for the common stock warrant liabilities were: (a) a risk-free interest rate based on the rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the remaining contractual term of the warrants; (b) an assumed dividend yield of zero based on the Company’s expectation that it will not pay dividends in the foreseeable future; (c) an expected term based on the remaining contractual term of the warrants; and (d) an expected volatility based upon the Company's historical volatility over the remaining contractual term of the warrants. The significant unobservable input used in measuring the fair value of the common stock warrant liabilities associated with the Deerfield Facility Agreement (described in Note 5 below) is the expected volatility. Significant increases in volatility would result in a higher fair value measurement.
|
Recent Accounting Pronouncements |
Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board ("FASB") issued new accounting guidance related to revenue recognition. This new standard will replace all current U.S. GAAP guidance on this topic and eliminate all industry-specific guidance. The new revenue recognition standard provides a unified model to determine when and how revenue is recognized. The core principle is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. On August 12, 2015, the FASB issued guidance deferring the effective date by one year to December 15, 2017 for annual reporting periods beginning after that date. The FASB also permitted early adoption of the standard, but not before the original effective date of December 15, 2016. The Company is currently evaluating the impact, if any, the adoption of this standard will have on its financial statements. In August 2014, the FASB issued guidance related to disclosures of uncertainties about an entity’s ability to continue as a going concern. The guidance requires management to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued. Management will be required to make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. Substantial doubt exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. The guidance is effective for annual periods ending after December 15, 2016 and for interim reporting periods within annual periods beginning after December 15, 2016, with early adoption permitted. The Company is currently evaluating the impact of this guidance and expects to adopt the standard for the annual reporting period ending December 31, 2016. In April 2015, the FASB issued guidance that amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. The guidance will not change the amortization of debt issuance costs, which will continue to follow the existing accounting guidance. The guidance is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. The Company is currently evaluating the impact of adopting this new accounting standard on its financial statements.
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v3.3.1.900
Select Balance Sheet Details (Tables)
|
9 Months Ended |
Sep. 30, 2015 |
Balance Sheet Related Disclosures [Abstract] |
|
Accounts Receivable, net |
Accounts receivable, net consist of the following (in thousands): | | | | | | | | | | September 30, 2015 | | December 31, 2014 | Accounts receivable | $ | 37,298 |
| | $ | 41,233 |
| Allowance for doubtful accounts | (1,046 | ) | | (793 | ) | Accounts receivable, net | $ | 36,252 |
| | $ | 40,440 |
|
|
Inventories, net |
Inventories, net consist of the following (in thousands) | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2015 | | December 31, 2014 | | Gross | | Reserve for excess and obsolete | | Net | | Gross | | Reserve for excess and obsolete | | Net | Raw materials | $ | 6,449 |
| | $ | — |
| | $ | 6,449 |
| | $ | 5,020 |
| | $ | — |
| | $ | 5,020 |
| Work-in-process | 1,898 |
| | — |
| | 1,898 |
| | 1,032 |
| | — |
| | 1,032 |
| Finished goods | 53,930 |
| | (19,949 | ) | | 33,981 |
| | 57,020 |
| | (21,325 | ) | | 35,695 |
| Inventories | $ | 62,277 |
| | $ | (19,949 | ) | | $ | 42,328 |
| | $ | 63,072 |
| | $ | (21,325 | ) | | $ | 41,747 |
|
|
Property and Equipment, net |
Property and equipment, net consist of the following (in thousands except as indicated): | | | | | | | | | | | | Useful lives (in years) | | September 30, 2015 | | December 31, 2014 | Surgical instruments | 4 | | $ | 64,838 |
| | $ | 62,872 |
| Machinery and equipment | 7 | | 15,585 |
| | 15,382 |
| Computer equipment | 3 | | 3,700 |
| | 3,180 |
| Office furniture and equipment | 5 | | 3,752 |
| | 3,789 |
| Leasehold improvements | various | | 3,854 |
| | 3,841 |
| Building | 39 | | 66 |
| | 65 |
| Land | n/a | | 9 |
| | 9 |
| Construction in progress | n/a | | 468 |
| | 1,320 |
| | | | 92,272 |
| | 90,458 |
| Less accumulated depreciation and amortization | | | (68,552 | ) | | (64,418 | ) | Property and equipment, net | | | $ | 23,720 |
| | $ | 26,040 |
|
|
Intangible Assets, net |
Intangible assets, net consist of the following (in thousands except for useful lives): | | | | | | | | | | | | Useful lives (in years) | | September 30, 2015 | | December 31, 2014 | Developed product technology | 3-8 | | $ | 21,825 |
| | $ | 22,526 |
| Distribution rights | 3 | | 2,100 |
| | 2,095 |
| Intellectual property | 5 | | 1,004 |
| | 1,004 |
| License agreements | 1-7 | | 16,716 |
| | 16,716 |
| Core technology | 10 | | 4,187 |
| | 4,554 |
| Trademarks and trade names | 3-9 | | 3,307 |
| | 3,559 |
| Customer-related | 12-15 | | 19,458 |
| | 20,493 |
| Distribution network | 10-12 | | 4,027 |
| | 4,027 |
| Physician education programs | 10 | | 2,575 |
| | 2,802 |
| Supply agreement | 10 | | 225 |
| | 225 |
| | | | 75,424 |
| | 78,001 |
| Less accumulated amortization | | | (52,481 | ) | | (47,742 | ) | Intangible assets, net | | | $ | 22,943 |
| | $ | 30,259 |
|
|
Schedule of Intangible assets, future amortization expense |
Future amortization expense related to intangible assets as of September 30, 2015 is as follows (in thousands): | | | | | Year Ending December 31, | | Remainder of 2015 | $ | 1,036 |
| 2016 | 4,059 |
| 2017 | 4,053 |
| 2018 | 2,884 |
| 2019 | 2,441 |
| Thereafter | 8,470 |
| | $ | 22,943 |
|
|
Accrued Expenses |
Accrued expenses consist of the following (in thousands): | | | | | | | | | | September 30, 2015 | | December 31, 2014 | Legal | $ | 554 |
| | $ | 967 |
| Accounting | 1,017 |
| | 1,262 |
| Severance | 322 |
| | 318 |
| Restructuring | 137 |
| | 531 |
| Sales milestones | 133 |
| | 107 |
| Accrued taxes | 729 |
| | 1,344 |
| Deferred rent | 462 |
| | 785 |
| Royalties | 1,712 |
| | 2,129 |
| Commissions | 5,189 |
| | 6,152 |
| Payroll and related | 5,359 |
| | 8,291 |
| Litigation settlements | 4,400 |
| | 7,393 |
| Accrued interest | 1,017 |
| | 946 |
| Other | 6,185 |
| | 5,168 |
| Total accrued expenses | $ | 27,216 |
| | $ | 35,393 |
|
|
Schedule of changes in carrying amount of goodwill |
The changes in the carrying amount of goodwill from December 31, 2014 through September 30, 2015 are as follows (in thousands): | | | | | | | Balance at December 31, 2014 | $ | 171,333 |
| Goodwill impairment | (164,266 | ) | Effect of foreign exchange rate on goodwill | (7,067 | ) | Balance at September 30, 2015 | $ | — |
|
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v3.3.1.900
Debt (Tables)
|
9 Months Ended |
Sep. 30, 2015 |
Debt Disclosure [Abstract] |
|
Level 3 Measurement Assumptions |
At September 30, 2015, the outstanding warrants were valued using the Black-Scholes option pricing model. This is a Level 3 measurement using the following assumptions: | | | | | September 30, 2015 | Risk-free interest rate | 1.3 | % | Dividend yield | — | % | Expected volatility | 63 | % | Expected life (years) | 4.5 |
|
|
Principal Payments on Debt |
Principal payments on debt are as follows as of September 30, 2015 (in thousands): | | | | | | | Year Ending December 31, | | Remainder of 2015 (1) | $ | 2,058 |
| 2016 (1) | 56,173 |
| 2017 (1) | 8,667 |
| 2018 (1) | 8,667 |
| 2019 (1) | 8,666 |
| Thereafter | — |
| Total | 84,231 |
| Add: capital lease principal payments | 1,471 |
| Less: debt discount | (5,765 | ) | Total | 79,937 |
| Less: current portion of long-term debt (1) | (79,253 | ) | Long-term debt, net of current portion | $ | 684 |
|
(1) The amounts above are presented based on the contractual payment schedules in each of the respective agreements. However, the debt balance under the Amended Credit Facility and the Facility Agreement was callable as of September 30, 2015 due to the event of default (See Note 1 and Note 5) and therefore, is presented as a current liability on the condensed consolidated balance sheet as of September 30, 2015.
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v3.3.1.900
Commitments and Contingencies (Tables)
|
9 Months Ended |
Sep. 30, 2015 |
Commitments and Contingencies Disclosure [Abstract] |
|
Future Minimum Annual Lease Payments |
Future minimum annual lease payments under such leases are as follows as of September 30, 2015 (in thousands): | | | | | | | | | Year Ending December 31, | Operating | | Capital | Remainder of 2015 | $ | 899 |
| | $ | 224 |
| 2016 | 2,318 |
| | 877 |
| 2017 | 846 |
| | 437 |
| 2018 | 272 |
| | 68 |
| 2019 | 137 |
| | — |
| | $ | 4,472 |
| | 1,606 |
| Less: amount representing interest | | | (135 | ) | Present value of minimum lease payments | | | 1,471 |
| Current portion of capital leases | | | (799 | ) | Capital leases, less current portion | | | $ | 672 |
|
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v3.3.1.900
Net Loss Per Share (Tables)
|
9 Months Ended |
Sep. 30, 2015 |
Earnings Per Share [Abstract] |
|
Weighted Average Number of Common Shares Outstanding |
For purposes of this calculation, common stock subject to repurchase by the Company, options 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 (in thousands, except per share data): | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2015 | | 2014 | | 2015 | | 2014 | Numerator: | | | | | | | | Net loss for basic earnings per share | $ | (160,265 | ) | | $ | (3,041 | ) | | $ | (168,773 | ) | | $ | (12,609 | ) | Decrease in fair value of warrants | — |
| | (513 | ) | | — |
| | (520 | ) | Diluted net loss applicable to common stockholders | $ | (160,265 | ) | | $ | (3,554 | ) | | $ | (168,773 | ) | | $ | (13,129 | ) | Denominator: | | | | | | | | Weighted average common shares outstanding | 100,144 |
| | 98,126 |
| | 100,092 |
| | 97,864 |
| Weighted average unvested common shares subject to repurchase | (768 | ) | | (735 | ) | | (834 | ) | | (824 | ) | Weighted average common shares outstanding—basic | 99,376 |
| | 97,391 |
| | 99,258 |
| | 97,040 |
| Effect of dilutive securities: | | | | | | | | Conversion of preferred stock | — |
| | — |
| | — |
| | — |
| Options | — |
| | — |
| | — |
| | — |
| Warrants | — |
| | 938 |
| | — |
| | 218 |
| Weighted average common shares outstanding—diluted | 99,376 |
| | 98,329 |
| | 99,258 |
| | 97,258 |
| Net loss per share: | | | | | | | | Basic | $ | (1.61 | ) | | $ | (0.03 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) | Diluted | $ | (1.61 | ) | | $ | (0.04 | ) | | $ | (1.70 | ) | | $ | (0.13 | ) |
|
Weighted-Average Anti-Dilutive Securities Not Included in Diluted Net Loss Per Share |
The anti-dilutive securities not included in diluted net loss per share were as follows (in thousands): | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2015 | | 2014 | | 2015 | | 2014 | Options to purchase common stock | 7,859 |
| | 6,904 |
| | 8,029 |
| | 7,199 |
| Unvested restricted share awards | 768 |
| | 735 |
| | 834 |
| | 824 |
| Warrants to purchase common stock | 11,544 |
| | 594 |
| | 11,544 |
| | 6,844 |
| Total | 20,171 |
| | 8,233 |
| | 20,407 |
| | 14,867 |
|
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v3.3.1.900
Segment and Geographical Information (Tables)
|
9 Months Ended |
Sep. 30, 2015 |
Segment Reporting [Abstract] |
|
Schedule of Revenues Attributed to Geographic Location of Customer |
Revenues attributed to the geographic location of the customer were as follows (in thousands): | | | | | | | | | | | | | | | | | | Three Months Ended | | Nine Months Ended | | September 30, | | September 30, | | 2015 | | 2014 | | 2015 | | 2014 | United States | $ | 27,385 |
| | $ | 34,808 |
| | $ | 85,099 |
| | $ | 101,376 |
| International | 15,611 |
| | 16,205 |
| | 53,177 |
| | 51,977 |
| Total consolidated revenues | $ | 42,996 |
| | $ | 51,013 |
| | $ | 138,276 |
| | $ | 153,353 |
|
|
Schedule of Long Lived Assets by Geographical Areas |
Total assets by region were as follows (in thousands): | | | | | | | | | | September 30, 2015 | | December 31, 2014 | United States | $ | 99,710 |
| | $ | 200,978 |
| International | 48,674 |
| | 143,945 |
| Total consolidated assets | $ | 148,384 |
| | $ | 344,923 |
|
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v3.3.1.900
The Company and Basis of Presentation - Additional Information (Details) $ in Thousands |
9 Months Ended |
|
Sep. 30, 2015
USD ($)
Market
|
Dec. 31, 2014
USD ($)
|
Error Corrections and Prior Period Adjustments Restatement [Line Items] |
|
|
Current portion of long-term debt |
$ 79,300
|
$ 8,076
|
Long-term debt, less current portion |
$ 700
|
$ 74,597
|
Number of market for products (more than 50) | Market |
50
|
|
Scenario, Previously Reported [Member] |
|
|
Error Corrections and Prior Period Adjustments Restatement [Line Items] |
|
|
Current portion of long-term debt |
$ 59,000
|
|
Long-term debt, less current portion |
$ 20,900
|
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v3.3.1.900
Summary of Significant Accounting Policies (Details) $ in Thousands |
9 Months Ended |
Sep. 30, 2015
USD ($)
|
Goodwill [Line Items] |
|
Revenue growth rate |
3.00%
|
Discount rate |
13.50%
|
Goodwill impairment |
$ 164,266
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] |
|
Balance at December 31, 2014 |
8,702
|
Balance at September 30, 2015 |
$ 687
|
Minimum [Member] |
|
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|
Revenue growth rate |
3.00%
|
Maximum [Member] |
|
Goodwill [Line Items] |
|
Revenue growth rate |
13.00%
|
Deerfield [Member] |
|
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] |
|
Changes in fair value |
$ (8,015)
|
X |
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v3.3.1.900
Select Balance Sheet Details - Inventories, Net (Details) - USD ($) $ in Thousands |
Sep. 30, 2015 |
Dec. 31, 2014 |
Balance Sheet Related Disclosures [Abstract] |
|
|
Raw materials, Gross |
$ 6,449
|
$ 5,020
|
Work-in-process, Gross |
1,898
|
1,032
|
Finished goods, Gross |
53,930
|
57,020
|
Inventory, Gross, Total |
62,277
|
63,072
|
Finished goods, Reserve for excess and obsolete |
(19,949)
|
(21,325)
|
Inventories, net, Reserve for excess and obsolete |
(19,949)
|
(21,325)
|
Raw materials, Net |
6,449
|
5,020
|
Work-in-process, Net |
1,898
|
1,032
|
Finished goods, Net |
33,981
|
35,695
|
Inventories, Net |
$ 42,328
|
$ 41,747
|
X |
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v3.3.1.900
Select Balance Sheet Details - Property and Equipment, Net (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2015 |
Sep. 30, 2014 |
Sep. 30, 2015 |
Sep. 30, 2014 |
Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Property and equipment, gross |
$ 92,272
|
|
$ 92,272
|
|
$ 90,458
|
Less accumulated depreciation and amortization |
(68,552)
|
|
(68,552)
|
|
(64,418)
|
Property and equipment, net |
23,720
|
|
23,720
|
|
26,040
|
Depreciation |
3,400
|
$ 2,900
|
$ 9,100
|
$ 9,200
|
|
Surgical instruments [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Useful lives |
|
|
4 years
|
|
|
Property and equipment, gross |
64,838
|
|
$ 64,838
|
|
62,872
|
Machinery and equipment [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Useful lives |
|
|
7 years
|
|
|
Property and equipment, gross |
15,585
|
|
$ 15,585
|
|
15,382
|
Capital leased assets, gross |
3,200
|
|
$ 3,200
|
|
3,200
|
Computer equipment [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Useful lives |
|
|
3 years
|
|
|
Property and equipment, gross |
3,700
|
|
$ 3,700
|
|
3,180
|
Office furniture and equipment [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Useful lives |
|
|
5 years
|
|
|
Property and equipment, gross |
3,752
|
|
$ 3,752
|
|
3,789
|
Leasehold improvements [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Various useful lives of leasehold improvements |
|
|
various
|
|
|
Property and equipment, gross |
3,854
|
|
$ 3,854
|
|
3,841
|
Building [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Useful lives |
|
|
39 years
|
|
|
Property and equipment, gross |
66
|
|
$ 66
|
|
65
|
Land [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Property and equipment, gross |
9
|
|
9
|
|
9
|
Construction in progress [Member] |
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Property and equipment, gross |
468
|
|
468
|
|
1,320
|
Capital leased assets, gross |
$ 200
|
|
$ 200
|
|
$ 600
|
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v3.3.1.900
Select Balance Sheet Details - Intangible Assets, Net (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2015 |
Sep. 30, 2014 |
Sep. 30, 2015 |
Sep. 30, 2014 |
Dec. 31, 2014 |
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Intangible assets, Gross |
$ 75,424
|
|
$ 75,424
|
|
$ 78,001
|
Less accumulated amortization |
(52,481)
|
|
(52,481)
|
|
(47,742)
|
Intangible assets, net |
22,943
|
|
22,943
|
|
30,259
|
Amortization |
1,100
|
$ 1,600
|
5,000
|
$ 4,800
|
|
Developed product technology [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Intangible assets, Gross |
21,825
|
|
$ 21,825
|
|
22,526
|
Developed product technology [Member] | Minimum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
3 years
|
|
|
Developed product technology [Member] | Maximum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
8 years
|
|
|
Distribution rights [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
3 years
|
|
|
Intangible assets, Gross |
2,100
|
|
$ 2,100
|
|
2,095
|
Intellectual property [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
5 years
|
|
|
Intangible assets, Gross |
1,004
|
|
$ 1,004
|
|
1,004
|
License agreements [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Intangible assets, Gross |
16,716
|
|
$ 16,716
|
|
16,716
|
License agreements [Member] | Minimum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
1 year
|
|
|
License agreements [Member] | Maximum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
7 years
|
|
|
License agreements [Member] | NEXoss Synthetic Bone Graft [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Impairment charges |
300
|
|
$ 300
|
|
|
License agreements [Member] | Epicage Interbody Fusion Device [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Impairment charges |
900
|
|
$ 900
|
|
|
Core technology [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
10 years
|
|
|
Intangible assets, Gross |
4,187
|
|
$ 4,187
|
|
4,554
|
Trademarks and trade names [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Intangible assets, Gross |
3,307
|
|
$ 3,307
|
|
3,559
|
Trademarks and trade names [Member] | Minimum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
3 years
|
|
|
Trademarks and trade names [Member] | Maximum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
9 years
|
|
|
Customer-related [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Intangible assets, Gross |
19,458
|
|
$ 19,458
|
|
20,493
|
Customer-related [Member] | Minimum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
12 years
|
|
|
Customer-related [Member] | Maximum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
15 years
|
|
|
Distribution network [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Intangible assets, Gross |
4,027
|
|
$ 4,027
|
|
4,027
|
Distribution network [Member] | Minimum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
10 years
|
|
|
Distribution network [Member] | Maximum [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
12 years
|
|
|
Physician education programs [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
10 years
|
|
|
Intangible assets, Gross |
2,575
|
|
$ 2,575
|
|
2,802
|
Impairment charges |
|
|
$ 900
|
|
|
Supply Agreement [Member] |
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
Useful lives |
|
|
10 years
|
|
|
Intangible assets, Gross |
$ 225
|
|
$ 225
|
|
$ 225
|
X |
- DefinitionThe aggregate amount of recurring noncash expense charged against earnings in the period to allocate the cost of assets over their estimated remaining economic lives.
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v3.3.1.900
Select Balance Sheet Details - Accrued Expense (Details) - USD ($) $ in Thousands |
Sep. 30, 2015 |
Dec. 31, 2014 |
Balance Sheet Related Disclosures [Abstract] |
|
|
Legal |
$ 554
|
$ 967
|
Accounting |
1,017
|
1,262
|
Severance |
322
|
318
|
Restructuring |
137
|
531
|
Sales milestones |
133
|
107
|
Accrued taxes |
729
|
1,344
|
Deferred rent |
462
|
785
|
Royalties |
1,712
|
2,129
|
Commissions |
5,189
|
6,152
|
Payroll and related |
5,359
|
8,291
|
Litigation settlements |
4,400
|
7,393
|
Accrued interest |
1,017
|
946
|
Other |
6,185
|
5,168
|
Total accrued expenses |
$ 27,216
|
$ 35,393
|
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v3.3.1.900
Debt - Additional Information (Details)
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
|
|
Jul. 10, 2015
USD ($)
|
Jul. 01, 2015
USD ($)
|
Nov. 21, 2014
USD ($)
$ / shares
shares
|
Mar. 20, 2014
USD ($)
$ / shares
shares
|
Aug. 30, 2013
USD ($)
|
Jul. 31, 2015
USD ($)
|
Apr. 30, 2014
USD ($)
|
Feb. 28, 2013
USD ($)
|
Sep. 30, 2015
USD ($)
shares
|
Sep. 30, 2015
USD ($)
payment
shares
|
Jul. 09, 2015
USD ($)
|
Dec. 31, 2014
USD ($)
|
Mar. 17, 2014
USD ($)
$ / shares
shares
|
Aug. 29, 2013
USD ($)
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized debt issuance and debt discount costs |
|
|
|
|
|
|
|
|
$ 5,765,000
|
$ 5,765,000
|
|
|
|
|
Amendment fee |
|
|
|
|
|
|
|
$ 100,000
|
|
|
|
|
|
|
Restricted cash |
|
|
|
|
|
|
|
|
3,450,000
|
3,450,000
|
|
$ 4,400,000
|
|
|
Common stock warrant liabilities |
|
|
|
|
|
|
|
|
687,000
|
687,000
|
|
$ 8,702,000
|
|
|
Prior Credit Facility with MidCap [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum borrowing capacity |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 50,000,000
|
Amended Credit Facility with MidCap [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum borrowing capacity |
|
|
|
|
$ 73,000,000
|
|
|
|
|
|
|
|
|
|
Term loan payments |
|
|
|
|
|
|
|
|
|
500,000
|
|
|
|
|
Debt issuance costs |
|
|
|
|
400,000
|
|
|
|
|
|
|
|
|
|
Unamortized debt issuance and debt discount costs |
|
|
|
|
|
|
|
|
300,000
|
300,000
|
|
|
|
|
Amended Credit Facility with MidCap [Member] | Term Loan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum borrowing capacity |
|
|
|
|
|
|
|
|
$ 38,000,000
|
$ 38,000,000
|
|
|
|
|
Proceeds from lines of credit |
|
|
|
|
$ 28,000,000
|
$ 5,000,000
|
$ 5,000,000
|
|
|
|
|
|
|
|
Basis spread |
|
|
|
|
|
|
|
|
|
8.00%
|
|
|
|
|
Interest rate description |
|
|
|
|
|
|
|
|
|
("LIBOR") plus 8.0%
|
|
|
|
|
Floor on interest rate |
|
|
|
|
|
|
|
|
|
9.50%
|
|
|
|
|
Interest rate |
|
|
|
|
|
|
|
|
9.50%
|
9.50%
|
|
|
|
|
Amended Credit Facility with MidCap [Member] | Credit Facility [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum borrowing base |
|
|
|
|
|
|
|
|
$ 40,000,000
|
$ 40,000,000
|
|
|
|
|
Line of credit |
|
|
|
|
|
|
|
|
$ 27,000,000
|
$ 27,000,000
|
|
|
|
|
Basis spread |
|
|
|
|
|
|
|
|
|
6.00%
|
|
|
|
|
Interest rate description |
|
|
|
|
|
|
|
|
|
LIBOR plus 6.0%
|
|
|
|
|
Interest rate |
|
|
|
|
|
|
|
|
6.20%
|
6.20%
|
|
|
|
|
Second Amendment Credit Facility with MidCap [Member] | Term Loan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum borrowing capacity |
$ 38,000,000
|
|
|
|
|
|
|
|
|
|
$ 33,000,000
|
|
|
|
Proceeds from lines of credit |
$ 5,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Monthly payments for term loan |
|
|
|
|
|
|
|
|
|
$ 500,000
|
|
|
|
|
Commitment fee percentage |
|
|
|
|
|
|
|
|
|
1.00%
|
|
|
|
|
Deerfield [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum borrowing capacity |
|
|
|
|
|
|
|
|
|
|
|
|
$ 50,000,000
|
|
Line of credit |
|
|
$ 6,000,000
|
$ 20,000,000
|
|
$ 5,000,000
|
|
|
$ 26,000,000
|
$ 26,000,000
|
|
|
|
|
Transaction fee as percentage of principal amount |
|
|
|
|
|
|
|
|
|
|
|
|
2.50%
|
|
Debt instrument, stated interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
8.75%
|
|
Number of securities called by warrants (in shares) | shares |
|
|
|
|
|
|
|
|
|
|
|
|
6,250,000
|
|
Exercise price of warrants (dollars per share) | $ / shares |
|
|
$ 1.39
|
$ 1.39
|
|
|
|
|
|
|
|
|
$ 1.39
|
|
Net proceeds from initial draw under Facility Agreement |
|
|
|
$ 19,500,000
|
|
|
|
|
|
|
|
|
|
|
Transaction fee |
|
|
$ 200,000
|
$ 500,000
|
|
|
|
|
|
|
|
|
|
|
Number of warrants issued (in shares) | shares |
|
|
1,200,000
|
4,000,000
|
|
|
|
|
|
|
|
|
|
|
Warrants value |
|
|
$ 900,000
|
$ 4,700,000
|
|
|
|
|
|
|
|
|
|
|
Warrant amount reclassified as debt discount |
|
|
|
$ 2,300,000
|
|
|
|
|
$ 200,000
|
$ 200,000
|
|
|
|
|
Net proceeds from draw under Facility Agreement |
|
|
$ 5,900,000
|
|
|
|
|
|
|
|
|
|
|
|
Equal annual payments | payment |
|
|
|
|
|
|
|
|
|
3
|
|
|
|
|
Warrants outstanding (in shares) | shares |
|
|
|
|
|
|
|
|
11,450,000
|
11,450,000
|
|
|
|
|
Changes in fair value |
|
|
|
|
|
|
|
|
$ 6,300,000
|
|
|
|
|
|
Changes in fair value |
|
|
|
|
|
|
|
|
|
$ (8,015,000)
|
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional interest rate to be charged in the event of default |
|
|
|
|
|
|
|
|
5.00%
|
5.00%
|
|
|
|
|
Maximum [Member] | Deerfield [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities called by warrants associated with each disbursement borrowing (in shares) | shares |
|
|
|
|
|
|
|
|
|
|
|
|
10,000,000
|
|
Orthotec LLC, Litigation Settlement [Member] | Deerfield [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Litigation settlement expense |
|
$ 1,100,000
|
|
|
|
|
|
|
|
$ 21,900,000
|
|
|
|
|
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Debt - Principal Payments on Debt (Details) $ in Thousands |
Sep. 30, 2015
USD ($)
|
Debt Disclosure [Abstract] |
|
Remainder of 2015 (1) |
$ 2,058
|
2016 |
56,173
|
2017 |
8,667
|
2018 |
8,667
|
2019 |
8,666
|
Thereafter |
0
|
Total |
84,231
|
Add: capital lease principal payments |
1,471
|
Less: debt discount |
(5,765)
|
Total |
79,937
|
Less: current portion of long-term debt (1) |
(79,253)
|
Long-term debt, net of current portion |
$ 684
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v3.3.1.900
Orthotec Settlement (Details) - Orthotec LLC, Litigation Settlement [Member]
|
|
1 Months Ended |
19 Months Ended |
Mar. 15, 2014
USD ($)
Installment
|
Apr. 30, 2014
USD ($)
|
Mar. 31, 2014
USD ($)
|
Sep. 30, 2015
USD ($)
|
Loss Contingencies [Line Items] |
|
|
|
|
Judgment assessed by court for (against) company |
$ (49,000,000)
|
|
|
|
Payments of settlement |
|
$ 15,750,000
|
$ 1,750,000
|
$ 21,900,000
|
Number of quarterly installments | Installment |
28
|
|
|
|
Litigation settlement interest, quarterly installments, amount |
$ 1,100,000
|
|
|
|
Beginning Fourth Quarter of 2014 [Member] |
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
Judgment assessed by court for (against) company |
(31,500,000)
|
|
|
|
Litigation settlement, quarterly installments, amount |
$ 1,100,000
|
|
|
|
Litigation settlement interest rate |
7.00%
|
|
|
|
Litigation settlement interest, quarterly installments, amount |
$ 1,100,000
|
|
|
|
Final Installment [Member] |
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
Number of quarterly installments | Installment |
1
|
|
|
|
Litigation settlement, final installment amount |
$ 700,000.0
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|
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v3.3.1.900
Net Loss Per Share - Weighted Average Number of Common Shares Outstanding (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2015 |
Sep. 30, 2014 |
Sep. 30, 2015 |
Sep. 30, 2014 |
Numerator: |
|
|
|
|
Net loss for basic earnings per share |
$ (160,265)
|
$ (3,041)
|
$ (168,773)
|
$ (12,609)
|
Decrease in fair value of warrants |
0
|
(513)
|
0
|
(520)
|
Diluted net loss applicable to common stockholders |
$ (160,265)
|
$ (3,554)
|
$ (168,773)
|
$ (13,129)
|
Denominator: |
|
|
|
|
Weighted average common shares outstanding (in shares) |
100,144
|
98,126
|
100,092
|
97,864
|
Weighted average unvested common shares subject to repurchase (in shares) |
(768)
|
(735)
|
(834)
|
(824)
|
Weighted average common shares outstanding—basic (in shares) |
99,376
|
97,391
|
99,258
|
97,040
|
Effect of dilutive securities: |
|
|
|
|
Dilutive effect of conversion of preferred stock, in shares |
0
|
0
|
0
|
0
|
Dilutive effect of options, in shares |
0
|
0
|
0
|
0
|
Dilutive effect of warrants, in shares |
0
|
938
|
0
|
218
|
Shares used in calculating diluted net loss per share |
99,376
|
98,329
|
99,258
|
97,258
|
Net loss per basic share |
$ (1.61)
|
$ (0.03)
|
$ (1.70)
|
$ (0.13)
|
Net loss per diluted share |
$ (1.61)
|
$ (0.04)
|
$ (1.70)
|
$ (0.13)
|
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Net Loss Per Share - Weighted-Average Anti-Dilutive Securities Not Included in Diluted Net Loss Per Share (Details) - shares shares in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2015 |
Sep. 30, 2014 |
Sep. 30, 2015 |
Sep. 30, 2014 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Anti-dilutive securities not included in diluted net loss per share |
20,171
|
8,233
|
20,407
|
14,867
|
Options to purchase common stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Anti-dilutive securities not included in diluted net loss per share |
7,859
|
6,904
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8,029
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7,199
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Unvested restricted share awards [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
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|
Anti-dilutive securities not included in diluted net loss per share |
768
|
735
|
834
|
824
|
Warrants to purchase common stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
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Anti-dilutive securities not included in diluted net loss per share |
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594
|
11,544
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6,844
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3 Months Ended |
9 Months Ended |
|
Sep. 30, 2015 |
Sep. 30, 2014 |
Sep. 30, 2015 |
Sep. 30, 2014 |
Dec. 31, 2014 |
Income Tax Disclosure [Abstract] |
|
|
|
|
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Unrecognized tax benefits increase (decrease) (less than $0.2 million) |
|
|
$ (200)
|
|
|
Unrecognized tax benefits |
$ 8,700
|
|
8,700
|
|
$ 8,900
|
Goodwill and intangible impairment |
165,171
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$ 0
|
$ 165,171
|
$ 0
|
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Income tax benefit |
$ 1,500
|
|
|
|
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3 Months Ended |
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Sep. 30, 2015
USD ($)
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Location
|
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|
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|
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|
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|
|
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|
|
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|
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2
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$ 51,013
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$ 153,353
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