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UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September
3, 2024
XTANT
MEDICAL HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-34951 |
|
20-5313323 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
664
Cruiser Lane
Belgrade,
Montana |
|
59714 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(406)
388-0480
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock, par value $0.000001 per share |
|
XTNT |
|
NYSE
American LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
As
previously reported in a Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) by Xtant
Medical Holdings, Inc., a Delaware corporation (the “Company”), on August 10, 2023 (the “Original Form 8-K”),
the Company acquired substantially all of the assets and certain specified liabilities of Surgalign Holdings, Inc., a Delaware corporation
(the “Seller”), and its subsidiaries pursuant to the Asset Purchase Agreement, dated June 18, 2023, between the Seller and
the Company (the “Acquisition”). On August 10, 2023, the Company completed the Acquisition.
On
October 26, 2023, the Company amended the Original Form 8-K to amend and supplement the Original Form 8-K to include historical financial
statements of the Seller and pro forma financial information as required by Items 9.01(a) and 9.01(b), respectively, of Form 8-K and
that were excluded from the Original Form 8-K in reliance on the instructions to such items (the “Amendment”).
The
Company intends to file a registration statement on Form S-3 with the SEC, and this Current Report on Form 8-K is being filed to provide
updated financial statements of the Seller for the six months ended June 30, 2023 (unaudited) and for the year ended December 31, 2022
and pro forma financial information for the year ended December 31, 2023 (collectively, the “Updated Financial Information”).
The Updated Financial Information updates and supplements the financial statements and pro forma information contained in Exhibit 99.1,
Exhibit 99.2 and Exhibit 99.3 to the Amendment. To the extent that the information in this Current Report on Form 8-K differs from or
updates information contained in the Amendment, the information in this Current Report on Form 8-K shall supersede or supplement the
information in the Amendment.
The
pro forma financial information included in Item 9.01(b) of this Current Report on Form 8-K has been presented for informational purposes
only, as required by Form S-3. It does not purport to represent the actual results or project future operating results of the Company
following the Acquisition.
Item
9.01 |
Financial
Statements and Exhibits. |
(a) |
Financial statements of businesses or funds acquired. |
The
financial statements of the Seller as of and for the six months ended June 30, 2023 and 2022 (unaudited) are filed as Exhibit 99.1 to
this Current Report on Form 8-K and incorporated herein by reference.
(b) |
Pro forma financial information. |
The
unaudited pro forma condensed combined statement of operations for the year ended December 31, 2023 and notes to the unaudited pro forma
condensed combined financial information of the Company, all giving effect to the Acquisition, are filed as Exhibit 99.2 to this Current
Report on Form 8-K and incorporated herein by reference.
SIGNATURE
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 hereunto duly authorized.
|
XTANT
MEDICAL HOLDINGS, INC. |
|
|
|
By: |
/s/
Scott Neils |
|
|
Scott
Neils |
|
|
Chief
Financial Officer |
Date:
September 3, 2024 |
|
|
Exhibit
99.1
SURGALIGN
HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except share data)
| |
June 30, 2023 | | |
December 31, 2022 | |
Assets | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 14,992 | | |
$ | 16,295 | |
Accounts receivable - less allowances of $9,890 at June 30, 2023 and $9,861 at December 31, 2022 | |
| 10,058 | | |
| 16,057 | |
Inventories - current | |
| 9,400 | | |
| 17,710 | |
Prepaid and other current assets | |
| 4,896 | | |
| 6,649 | |
Total current assets | |
$ | 39,346 | | |
$ | 56,711 | |
Non-current inventories | |
| 6,148 | | |
| 5,947 | |
Property and equipment - net | |
| 1,921 | | |
| 2,057 | |
Other assets - net | |
| 5,713 | | |
| 5,527 | |
Total assets | |
$ | 53,128 | | |
$ | 70,242 | |
| |
| | | |
| | |
Liabilities, Mezzanine Equity and Stockholders’ Equity | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 5,253 | | |
$ | 7,705 | |
Accrued expenses | |
| 12,090 | | |
| 13,146 | |
Accrued income taxes | |
| 402 | | |
| 296 | |
Total current liabilities | |
$ | 17,745 | | |
$ | 21,147 | |
Acquisition contingencies – Holo | |
| 22,995 | | |
| 24,061 | |
Warrant liability | |
| — | | |
| 22,982 | |
Notes payable - related party | |
| 10,244 | | |
| 10,192 | |
Other long-term liabilities | |
| 7,906 | | |
| 7,583 | |
Total liabilities | |
$ | 58,890 | | |
$ | 85,965 | |
Commitments and contingencies (Note 17) | |
| | | |
| | |
| |
| | | |
| | |
Mezzanine equity | |
| 10,006 | | |
| 10,006 | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, $.001 par value: 300,000,000 shares authorized; 9,176,688 and 7,860,369 shares issued and outstanding, as of June 30, 2023 and December 31, 2022, respectively | |
| 8 | | |
| 7 | |
Additional paid-in capital | |
| 611,397 | | |
| 607,245 | |
Accumulated other comprehensive loss | |
| (2,838 | ) | |
| (2,840 | ) |
Accumulated deficit | |
| (618,392 | ) | |
| (624,218 | ) |
Less treasury stock, 76,769 and 66,641 shares, as of June 30, 2023 and December 31, 2022, respectively, at cost | |
| (5,943 | ) | |
| (5,923 | ) |
Total stockholders’ equity | |
$ | (15,768 | ) | |
$ | (25,729 | ) |
Total liabilities, mezzanine equity and stockholders’ equity | |
$ | 53,128 | | |
$ | 70,242 | |
See
notes to unaudited condensed consolidated financial statements.
SURGALIGN
HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Income
(Unaudited, in thousands, except share and per share data)
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Revenues | |
$ | 30,293 | | |
$ | 41,228 | |
Cost of goods sold | |
| 10,341 | | |
| 12,824 | |
Gross profit | |
| 19,952 | | |
| 28,404 | |
Operating Expenses: | |
| | | |
| | |
General and administrative | |
| 40,784 | | |
| 49,606 | |
Severance and restructuring costs | |
| 932 | | |
| — | |
Research and development | |
| 5,810 | | |
| 8,530 | |
Gain on acquisition contingency | |
| (1,066 | ) | |
| (10,493 | ) |
Asset impairment and abandonments | |
| 637 | | |
| 1,935 | |
Transaction and financing expenses | |
| 463 | | |
| 1,138 | |
Total operating expenses | |
| 47,560 | | |
| 50,716 | |
Gain on sale of Coflex | |
| (12,631 | ) | |
| — | |
Operating loss | |
| (14,977 | ) | |
| (22,312 | ) |
Other (income) expense - net | |
| | | |
| | |
Other (income) expense - net | |
| (295 | ) | |
| 49 | |
Interest expense | |
| 504 | | |
| 504 | |
Foreign exchange (gain) loss | |
| (480 | ) | |
| 1,409 | |
Change in fair value of warrant liability | |
| (20,800 | ) | |
| (18,867 | ) |
Total other income - net | |
| (21,071 | ) | |
| (16,905 | ) |
Income before income tax provision | |
| 6,094 | | |
| (5,407 | ) |
Income tax provision | |
| 268 | | |
| 254 | |
Net income (loss) from operations | |
| 5,826 | | |
| (5,661 | ) |
| |
| | | |
| | |
Other comprehensive income (loss) | |
| | | |
| | |
Unrealized foreign currency translation gain | |
| (1,020 | ) | |
| (422 | ) |
Total other comprehensive income (loss) | |
| 6,846 | | |
| (5,239 | ) |
| |
| | | |
| | |
Net income (loss) per common share - basic | |
| 0.72 | | |
| (0.92 | ) |
Net income (loss) per common share - diluted | |
| 0.66 | | |
| (0.92 | ) |
Weighted average shares outstanding - basic | |
| 8,072,339 | | |
| 6,174,273 | |
Weighted average shares outstanding - diluted | |
| 8,766,184 | | |
| 6,174,273 | |
See
notes to unaudited condensed consolidated financial statements.
SURGALIGN
HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Stockholders’ Equity
(Unaudited, in thousands)
| |
Common Stock | | |
Additional Paid-In Capital | | |
Accumulated Other Comprehensive Loss | | |
Accumulated Deficit | | |
Treasury Stock | | |
Total | | |
Mezzanine Equity | |
Balance, January 1, 2023 | |
$ | 7 | | |
$ | 607,245 | | |
$ | (2,840 | ) | |
$ | (624,218 | ) | |
$ | (5,923 | ) | |
$ | (25,729 | ) | |
$ | 10,006 | |
Net income | |
| — | | |
| — | | |
| — | | |
| 4,145 | | |
| — | | |
| 4,145 | | |
| — | |
Foreign currency translation adjustment | |
| — | | |
| — | | |
| (509 | ) | |
| — | | |
| — | | |
| (509 | ) | |
| — | |
Share offering | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Prefunded warrant execution | |
| 1 | | |
| 2,182 | | |
| — | | |
| — | | |
| — | | |
| 2,183 | | |
| — | |
Equity instruments issued in connection with the Holo acquisition | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Stock-based compensation | |
| — | | |
| 995 | | |
| — | | |
| — | | |
| — | | |
| 995 | | |
| — | |
Purchase of treasury stock | |
| — | | |
| — | | |
| — | | |
| — | | |
| (20 | ) | |
| (20 | ) | |
| — | |
Balance, March 31, 2023 | |
$ | 8 | | |
$ | 610,422 | | |
$ | (3,349 | ) | |
$ | (620,073 | ) | |
$ | (5,943 | ) | |
$ | (18,935 | ) | |
$ | (10.006 | ) |
Net Income | |
| — | | |
| — | | |
| — | | |
| 1,681 | | |
| — | | |
| 1,681 | | |
| — | |
Foreign currency translation adjustment | |
| — | | |
| — | | |
| 511 | | |
| — | | |
| — | | |
| 511 | | |
| — | |
Stock-based compensation | |
| — | | |
| 975 | | |
| — | | |
| — | | |
| — | | |
| 975 | | |
| — | |
Balance, June 30, 2023 | |
$ | 8 | | |
$ | 611,397 | | |
$ | (2,838 | ) | |
$ | (618,392 | ) | |
$ | (5,943 | ) | |
$ | (15,768 | ) | |
$ | 10,006 | |
| |
Common Stock | | |
Additional Paid-In Capital | | |
Accumulated Other Comprehensive Loss | | |
Accumulated Deficit | | |
Treasury Stock | | |
Total | | |
Mezzanine Equity | |
Balance, January 1, 2022 | |
$ | 75 | | |
$ | 585,517 | | |
$ | (1,820 | ) | |
$ | (569,613 | ) | |
$ | (5,852 | ) | |
$ | 8,237 | | |
$ | 10,006 | |
Net income | |
| — | | |
| — | | |
| — | | |
| 27 | | |
| — | | |
| 27 | | |
| — | |
Foreign currency translation adjustment | |
| — | | |
| — | | |
| (109 | ) | |
| — | | |
| — | | |
| (109 | ) | |
| — | |
Share offering | |
| 1 | | |
| 8,487 | | |
| — | | |
| — | | |
| — | | |
| 8,488 | | |
| — | |
Prefunded warrant execution | |
| — | | |
| 1,749 | | |
| — | | |
| — | | |
| — | | |
| 1,749 | | |
| — | |
Equity instruments issued in connection with the Holo acquisition | |
| — | | |
| 5,918 | | |
| — | | |
| — | | |
| — | | |
| 5,919 | | |
| — | |
Stock-based compensation | |
| — | | |
| 1,374 | | |
| — | | |
| — | | |
| — | | |
| 1,374 | | |
| — | |
Purchase of treasury stock | |
| — | | |
| — | | |
| — | | |
| — | | |
| (5 | ) | |
| (5 | ) | |
| — | |
Balance, March 31, 2022 | |
$ | 7 | | |
$ | 603,042 | | |
$ | (1,929 | ) | |
$ | (569,586 | ) | |
$ | (5,857 | ) | |
$ | 25,680 | | |
$ | (10.006 | ) |
Net Income | |
| — | | |
| — | | |
| — | | |
| (5,688 | ) | |
| — | | |
| (5,688 | ) | |
| — | |
Foreign currency translation adjustment | |
| — | | |
| — | | |
| (313 | ) | |
| — | | |
| — | | |
| (313 | ) | |
| — | |
Stock-based compensation | |
| — | | |
| 971 | | |
| — | | |
| — | | |
| — | | |
| 971 | | |
| — | |
Purchase of stock in the ESPP Plan | |
| — | | |
| 186 | | |
| — | | |
| — | | |
| — | | |
| 186 | | |
| — | |
Purchase of treasury stock | |
| — | | |
| — | | |
| — | | |
| — | | |
| (51 | ) | |
| (51 | ) | |
| — | |
Other | |
| — | | |
| 50 | | |
| — | | |
| — | | |
| — | | |
| 50 | | |
| — | |
Balance, June 30, 2022 | |
$ | 7 | | |
$ | 604,252 | | |
$ | (2,242 | ) | |
$ | (575,274 | ) | |
$ | (5,908 | ) | |
$ | 20,835 | | |
$ | 10,006 | |
See
notes to unaudited condensed consolidated financial statements.
SURGALIGN
HOLDINGS, INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(Unaudited,
in thousands)
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net income (loss) | |
$ | 5,826 | | |
$ | (5,661 | ) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization expense | |
| 999 | | |
| 1,180 | |
Provision for bad debts and product returns | |
| 58 | | |
| 700 | |
Investor fee | |
| — | | |
| 916 | |
Change in fair value of warrant liability | |
| (20,800 | ) | |
| (18,867 | ) |
Provision for inventory write-downs | |
| 430 | | |
| 3,804 | |
Deferred income tax provision | |
| (42 | ) | |
| — | |
Stock-based compensation | |
| 1,970 | | |
| 2,299 | |
Asset impairment and abandonments | |
| 553 | | |
| 1,935 | |
Gain on acquisition contingency | |
| (1,066 | ) | |
| (10,493 | ) |
Gain on sale of Coflex | |
| (12,631 | ) | |
| — | |
Other | |
| (35 | ) | |
| (3 | ) |
Change in assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| 5,941 | | |
| (2,082 | ) |
Inventories | |
| 5,510 | | |
| (4,767 | ) |
Accounts payable | |
| (2,452 | ) | |
| 446 | |
Accrued expenses | |
| (2,733 | ) | |
| (7,025 | ) |
Right-of-use asset and lease liability | |
| (360 | ) | |
| 223 | |
Other operating assets and liabilities | |
| 1,879 | | |
| 4,986 | |
Net cash used in operating activities | |
$ | (16,953 | ) | |
$ | (32,409 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (1,297 | ) | |
| (3,034 | ) |
Disposal of Coflex | |
| 17,000 | | |
| — | |
Patent and acquired intangible asset costs | |
| (35 | ) | |
| (184 | ) |
Net cash provided by (used in) investing activities | |
$ | 15,668 | | |
$ | (3,218 | ) |
Cash flows from financing activities: | |
| | | |
| | |
Share offering proceeds including prefunded warrant exercised, net | |
| — | | |
| 17,729 | |
Payment of Holo Milestones - contingent consideration | |
| — | | |
| (4,081 | ) |
Proceeds from Employee Stock Purchase Program (ESPP) | |
| — | | |
| 186 | |
Pre-funded warrant execution | |
| 1 | | |
| — | |
Payments for treasury stock | |
| (20 | ) | |
| (56 | ) |
Net cash (used in) provided by financing activities | |
$ | (19 | ) | |
$ | 13,778 | |
Effect of exchange rate changes on cash and cash equivalents | |
| 1 | | |
| (94 | ) |
Net decrease in cash and cash equivalents | |
| (1,303 | ) | |
| (21,943 | ) |
Cash and cash equivalents, beginning of period | |
| 16,295 | | |
| 51,287 | |
Cash and cash equivalents, end of period | |
$ | 14,992 | | |
$ | 29,344 | |
Supplemental cash flow disclosure: | |
| | | |
| | |
Net income tax payments, net of refunds | |
$ | 476 | | |
$ | 1,548 | |
Non-cash acquisition of property and equipment | |
| 9 | | |
| 189 | |
Non-cash common stock issuance - Holo Milestones contingent considerations | |
| — | | |
| 5,919 | |
See
notes to unaudited condensed consolidated financial statements.
SURGALIGN
HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share data or otherwise noted)
Surgalign
Holdings, Inc. (the “Company”, “we,” “us,” or “our”) is a global medical technology company.
We market and sell products to hospitals, ambulatory surgery centers, and healthcare providers in the United States and in approximately
40 countries worldwide. We are headquartered in Deerfield, Illinois, with commercial, innovation and design centers in San Diego, California;
Wurmlingen, Germany; and Warsaw, Poland. The Company operates one reportable segment: Spine.
Disposition
of Coflex and Cofix Product Lines
On
February 28, 2023, pursuant to an Equity Purchase Agreement (the “Coflex Purchase Agreement”) by and among the Company’s
indirect subsidiary, Surgalign SPV, Inc., a Delaware corporation (“Surgalign SPV”), Surgalign Spine Technologies, Inc, a
Delaware corporation and sole stockholder of Surgalign SPV (the “Seller”), the Company, and Xtant Medical Holdings, Inc.,
a Delaware corporation (“Xtant”), Xtant acquired 100% of the issued and outstanding equity of Surgalign SPV from the Seller
(the “Coflex Transaction”). The aggregate consideration paid in the Coflex Transaction was $17.0 million in cash which resulted
in net proceeds of $14.8 million to the Company after transaction fees of $2.2 million which were paid to the financial advisors and
lawyers associated with the transaction.
As
a result of the Coflex Transaction, Xtant acquired the Coflex and Cofix product lines in the United States which had a net book value
of $2.2 million as of the date of the Coflex Transaction. The net book value of the assets was entirely associated with the inventory
of Coflex and Cofix. In addition, Xtant acquired the worldwide intellectual property rights of the Coflex and Cofix product lines, which
had no book value as of the date of the transaction. No other assets or liabilities were transferred to Xtant and as such the Company
recorded a gain of $12.6 million related to the Coflex Transaction. In connection with the Coflex Transaction, the Seller, Surgalign
SPV and Xtant also entered into a Transition Services Agreement, dated as of February 28, 2023 (the “Transition Services Agreement”),
pursuant to which the Seller agreed to provide certain transition services to Xtant immediately after the closing for an agreed upon
transition period.
Reverse
Stock Split
On
May 10, 2022, the stockholders of the Company approved the proposal to authorize the Company’s Board of Directors (the “Board”)
to amend the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s
common stock (the “Reverse Stock Split”). Following Board approval on May 11, 2022, the Reverse Stock Split became effective
on May 16, 2022 at a 1-for-30 ratio. The Reverse Stock Split did not modify any rights or preferences of the shares of the Company’s
common stock. Proportionate adjustments were made to the exercise prices and the number of shares underlying the Company’s outstanding
equity awards, as applicable, and warrants, as well as to the number of shares issued and issuable under the Company’s equity incentive
plans. The Reverse Stock Split did not affect the number of authorized shares of common stock or the par value of the common stock. Unless
we indicate otherwise, all per share amounts and references to common shares and common share amounts in these financial statements reflect
the Reverse Stock Split, and the accompanying financial statements and notes to the financial statements give effect to the Reverse Stock
Split and have been retroactively applied.
Going
Concern and Liquidation
The
accompanying condensed consolidated financial statements of the Company have been prepared assuming the Company will continue as a going
concern and in accordance with generally accepted accounting principles in the United States of America. On August 10, 2023, Xtant acquired
substantially all of the assets and certain specified liabilities of the Company, and its subsidiaries pursuant to the Asset Purchase
Agreement, dated June 18, 2023, between the Company and Xtant.
The
accompanying condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, which the
Company considers necessary for a fair presentation of the results of operations for the periods shown. The condensed consolidated financial
statements have been prepared in accordance with the instructions to Form 10-Q and Regulation S-X, and therefore, do not include all
information and footnotes necessary for a fair presentation of the condensed consolidated financial position, results of operations,
comprehensive loss and cash flows in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
The preparation of our condensed consolidated financial statements in accordance with GAAP often requires us to make estimates and judgments
that affect reported amounts. These estimates and judgments are based on historical experience and assumptions that we believe to be
reasonable under the circumstances. Assumptions and judgments based on historical experience may provide reported results, which differ
from actual results; however, these assumptions and judgments historically have not varied significantly from actual experience, and
we therefore do not expect them to vary significantly in the future. All intercompany balances and transactions have been eliminated
in consolidation. The results of operations for any interim period are not necessarily indicative of the results to be expected for the
full year. The Company includes acquisition, disposal, integration and separation related costs, which are predominantly composed of
legal, consulting, and advisor fee expenses, within the “Transaction and integration expense” line on the condensed consolidated
statements of comprehensive income.
The
condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Surgalign Spine Technologies,
Inc., Paradigm Spine, LLC (“Paradigm”), Pioneer Surgical Technology, Inc. (“Pioneer Surgical”), Holo Surgical
Inc. (“Holo Surgical”), and Prompt Prototypes, LLC (“Prompt”). The operating results of the disposed OEM Businesses
have been reported as discontinued operations in the condensed consolidated financial statements in the prior comparative periods. The
Company consolidates the accounts of Inteneural Networks Inc. (“INN”), a 42% owned subsidiary, as control was achieved through
means other than voting rights (“variable interest entities” or
“VIE”) as the Company is deemed
to be the primary beneficiary of INN.
For
further information on the Company’s significant accounting policies, refer to the consolidated financial statements and notes
thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and
Exchange Commission (“SEC”) on March 30, 2023.
Accounting
Standards Issued But Not Yet Adopted
To
date, there have been no recent accounting pronouncements not yet effective that have a material, or potentially material, impact to
our consolidated financial statements.
Significant
New Accounting Policies
There
are no new accounting policies effective for this reporting period that have a material impact on the financial statements.
The
Company’s leases are classified as operating leases that include office space, automobiles, and copiers. The Company does not have
any finance leases and the Company’s operating leases do not have any residual value guarantees, restrictions, or covenants.
The
Company’s leases have remaining lease terms of 1 to 7 years, some of which include options to extend or terminate the leases. The
option to extend is only included in the lease term if the Company is reasonably certain of exercising that option. Operating lease ROU
assets are presented within “Other assets-net” on the condensed consolidated balance sheets. The current portion of operating
lease liabilities are presented within “Accrued expenses,” and the non-current portion of operating lease liabilities are
presented within “Other long-term liabilities” on the condensed consolidated balance sheets. The Company’s lease agreements
do not provide a readily determinable implicit rate nor is it available to the Company from its lessors. Instead, the Company estimates
its incremental borrowing rate based on information available at lease commencement in order to discount lease payments to present value.
Short-term leases with an initial term of 12 months or less are not recorded on the consolidated balance sheets.
A
subset of the Company’s automobile and copier leases contain variable payments. The variable lease payments for such automobile
leases are based on actual mileage incurred at the standard contractual rate. The variable lease payments for such copier leases are
based on actual copies incurred at the standard contractual rate. The variable lease costs for all leases are immaterial.
Supplemental
cash flow information related to operating leases was as follows:
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 225 | | |
$ | 686 | |
ROU assets obtained in exchange for lease obligations | |
| 149 | | |
| — | |
4. |
Revenue from Contracts with Customers |
The
Company recognizes revenue upon transfer of control of promised products in an amount that reflects the consideration it expects to receive
in exchange for those products. The Company typically transfers control at a point in time upon shipment or delivery of the implants
for direct sales, or upon implantation for sales of consigned inventory. The customer is able to direct the use of and obtain substantially
all of the benefits from the implant at the time the implant is shipped, delivered, or implanted, based on the terms of the contract.
Disaggregation
of Revenue
The
Company’s entire revenue for the six months ended June 30, 2023 and 2022 was recognized at a point in time. The following table
represents total revenue by geographical region for the six months ended June 30, 2023 and 2022, respectively:
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Revenues: | |
| | | |
| | |
Domestic | |
$ | 24,463 | | |
$ | 34,299 | |
International | |
| 5,830 | | |
| 6,929 | |
Total revenues from contracts with customers | |
$ | 30,293 | | |
$ | 41,228 | |
5. |
Inteneural Networks Inc. |
The
Company acquired a 42% equity interest in INN on December 30, 2021 and has a non-exclusive right to use its proprietary technology. Management
has determined that the Company obtained control through means other than voting rights as the Company is deemed to be the primary beneficiary
and is the most closely associated decision maker under ASC 810, Consolidation. Based on this, the Company has considered INN
to be a VIE, and INN was fully consolidated into the condensed consolidated financial statements as of June
30, 2023. INN does not have any assets or liabilities as of June 30, 2023 and December 31,
2022. Additionally, there was no income statement activity within INN for the six months ended
June 30, 2023 and 2022.
As
part of the acquisition, the Company has the ability to acquire the remaining 58% equity interest in INN based on the achievement of
three separate regulatory and revenue based milestones. The Company will pay $19.3 million for each individual milestone achieved, resulting
in a corresponding additional 19.3% equity interest in INN per milestone achieved. None of the three milestones has been achieved as
of June 30, 2023.
6. |
Stock-Based Compensation |
The
following tables summarize our stock option and stock grant awards by plan:
For
the six months ended June 30, 2023:
Plan | |
Stock Options | | |
Restricted Stock Awards | | |
Restricted Stock Units | | |
Total | |
2021 Incentive Inducement Plan | |
| — | | |
| — | | |
| — | | |
| — | |
2021 Incentive Compensation Plan | |
| — | | |
| — | | |
| 5,000 | | |
| 5,000 | |
Total | |
| — | | |
| — | | |
| 5,000 | | |
| 5,000 | |
For
the six months ended June 30, 2022:
Plan | |
Stock Options | | |
Restricted Stock Awards | | |
Restricted Stock Units | | |
Total | |
2021 Incentive Inducement Plan | |
| — | | |
| — | | |
| 116,948 | | |
| 116,948 | |
2021 Incentive Compensation Plan | |
| — | | |
| — | | |
| 4,277 | | |
| 4,277 | |
Total | |
| — | | |
| — | | |
| 121,225 | | |
| 121,225 | |
The
Company recognized stock-based compensation as follows:
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Stock-based compensation: | |
| | | |
| | |
General and administrative | |
$ | 868 | | |
$ | 2,123 | |
Research and development | |
| 117 | | |
| 176 | |
Total | |
$ | 985 | | |
$ | 2,299 | |
The
expense in the table above represents stock-based compensation for outstanding awards, and related expenses for the Company’s employee
stock purchase program.
7. |
Net Income Per Common Share |
For
the six months ended June 30, 2023, the Company has recorded net income from operations.
As a result, the Company has included a reconciliation presenting income and loss activity utilized to calculate basic earnings per share
and diluted earnings per share. Diluted earnings per share is adjusted for the impact of changes in the fair value of the pre-funded
warrants and warrants to the extent they are dilutive:
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Net income (loss) from continuing operations-basic | |
$ | 5,826 | | |
$ | (5,661 | ) |
Effect of diluted stock options | |
| — | | |
| — | |
Effect of diluted restricted stock units and restricted stock awards | |
| — | | |
| — | |
Effect of diluted pre-funded warrants | |
| (1,415 | ) | |
| — | |
Effect of diluted warrants | |
| — | | |
| — | |
Net (loss) income from continuing operations-diluted | |
$ | 4,411 | | |
$ | (5,661 | ) |
A
reconciliation of the number of shares of common stock used in the calculation of basic and diluted net loss per common share is presented
below:
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Weighted average basic shares | |
$ | 8,072,339 | | |
$ | 6,174,273 | |
Stock options | |
| — | | |
| — | |
Restricted stock units and restricted stock awards | |
| 639,845 | | |
| — | |
Pre-funded warrants | |
| — | | |
| — | |
Warrants | |
| — | | |
| — | |
Weighted average diluted shares | |
$ | 8,766,184 | | |
$ | 6,174,273 | |
For
the six months ended June 30, 2023 and 2022, the Company excluded 73,891 and 103,982, respectively, of issued stock options in the computation
of diluted net income (loss) per common share because their exercise price exceeded the average market price during the respective periods.
The Company’s outstanding warrants were also excluded from the computation of diluted net loss per common share as they were considered
“out-of-the-money” as of June 30, 2023 and 2022.
The
inventory balances as of June 30, 2023 and December 31, 2022 consist entirely of finished goods. The Company values its inventories at
the lower of net realizable value or cost using first-in, first-out (“FIFO”).
For
the six months ended June 30, 2023 and 2022, the Company had inventory write-downs of $0.4 million and $3.8 million, respectively, primarily
related to excess quantities and obsolescence (“E&O”) of inventories. The E&O write-downs are included in the “Cost
of goods sold” on the condensed consolidated statements of comprehensive income. Please see Note 17 for further discussion.
9. |
Prepaid and Other Current Assets |
Prepaid
and other current assets are as follows:
| |
June 30, 2023 | | |
December 31, 2022 | |
Leasehold improvement reimbursement | |
$ | 1,564 | | |
$ | 2,885 | |
Prepaid rent-San Diego Lease Design Center | |
| 1,374 | | |
| — | |
Income tax receivable | |
| 392 | | |
| 958 | |
OEM safety stock receivable | |
| — | | |
| 900 | |
Prepaid expenses | |
| 717 | | |
| 941 | |
Other receivable | |
| 849 | | |
| 965 | |
Total prepaid and other current assets | |
$ | 4,896 | | |
$ | 6,649 | |
10. |
Property and Equipment |
The
net book value of property and equipment after accumulated depreciation and all impairment is as follows:
| |
June 30, 2023 | | |
December 31, 2022 | |
Processing equipment | |
$ | 194 | | |
$ | 266 | |
Surgical instruments | |
| 426 | | |
| 543 | |
Office equipment, furniture and fixtures | |
| 1 | | |
| 1 | |
Computer equipment and software | |
| 1,300 | | |
| 40 | |
Construction in process | |
| — | | |
| 1,207 | |
| |
$ | 1,921 | | |
$ | 2,057 | |
For
the six months ended June 30, 2023 and 2022, the Company recorded depreciation expense in connection with property and equipment of $1.0
million and $1.1 million, respectively. The Company uses
the straight-line method of depreciation.
For
the six months ended June 30, 2023 and 2022, the Company recorded asset impairment and abandonment charges of $0.6 million and $1.9 million,
respectively. The fair value of property and equipment
was measured utilizing an orderly liquidation value of each of the underlying assets. Refer to Note 11 for further information on impairment.
The
below table summarizes the activity within the construction in progress line item, as of June 30, 2023 and December 31, 2022, which includes
the capitalized software costs:
| |
June 30, 2023 | | |
December 31, 2022 | |
Beginning balance as of January 1 | |
$ | 1,207 | | |
$ | 51 | |
Capitalized | |
| 422 | | |
| 1,207 | |
Impairment | |
| — | | |
| — | |
Assets transferred into service | |
| (1,629 | ) | |
| (51 | ) |
Ending balance | |
$ | — | | |
$ | 1,207 | |
For
the six months ended June 30, 2023 and 2022, the Company capitalized a total of $0.4 million and $0.0 million, respectively, of employee
costs related to enhancements for the HOLO™ Portal surgical guidance system. In late March 2023, the related system enhancements
were launched, thus leading to further functionality and operations of the system. As such the Company moved $1.6 million of costs from
“Construction in process” line to the “Computer equipment and software” line on the condensed consolidated balance
sheet as of June 30, 2023. As the enhancements were launched late in March 2023, the amount of amortization recorded for the period ending
June 30, 2023 was immaterial. The Company has assessed the capitalized software for impairment and determined no impairment has been
taken as the Company has determined cost incurred will result in additional functionality for the system.
11. |
Fair Value Information |
Fair
value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction
between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs
and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for classification and
disclosure of fair value measurements as follows:
Level
1 – Quoted prices in active markets for identical assets or liabilities.
Level
2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
or liabilities.
Acquisition
Contingencies
Changes
in the fair value of contingent consideration are recorded in the “Gain on acquisition contingency” line in the condensed
consolidated statement of income. Significant changes in unobservable inputs, mainly the
probability of success and projected cash flows, could result in material changes to the contingent consideration liability. The contingent
consideration is evaluated quarterly, or more frequently if circumstances dictate.
Holo
Surgical
On
September 29, 2020, the Company entered into a stock purchase agreement (the “Holo Purchase Agreement”), with Roboticine,
Inc, a Delaware corporation (the “Seller”), Holo Surgical S.A., a Polish joint-stock company (“Holo S.A.”), Pawel
Lewicki, PhD (“Lewicki”), and Krzysztof Siemionow, MD, PhD (“Siemionow”), which provides for the Company to acquire
all of the issued and outstanding equity interests in Holo Surgical Inc., a Delaware corporation and a wholly owned subsidiary of the
Seller (“Holo Surgical”). The Seller, Holo S.A., Lewicki and Siemionow are together referred to as the “Seller Group
Members.” The Acquisition was closed on October 23, 2020.
As
consideration for the Holo Surgical acquisition, the Company paid to the Seller $30.0 million in cash and issued to the Seller 208,333
shares of its common stock, par value $0.001. In addition, the Seller is entitled to receive contingent consideration from the Company
valued in an aggregate amount of up to $83.0 million, to be paid through the issuance of common stock or the payment of cash, contingent
upon and following the achievement of certain regulatory, commercial, and utilization milestones by specified time periods occurring
up to the sixth (6th) anniversary of the closing.
The
Holo Purchase Agreement provides that the Company will issue common stock to satisfy any contingent consideration payable to the Seller,
until the total number of shares of common stock issued to the Seller pursuant to the Holo Purchase Agreement (including the 208,333
shares of common stock issued at closing) is equal to 496,666 shares of common stock. Following the attainment of that limitation, the
post-closing contingent payments would be payable in cash. The number of shares of common stock issued as contingent consideration with
respect to the achievement of a post-closing milestone, if any, will be calculated based on the volume weighted average price of the
Company’s common stock for the five (5) day trading period commencing on the opening of trading on the third trading day following
the achievement of the applicable milestone. On January 12, 2022, the Company entered into a Second Amendment to the Holo Purchase Agreement
with the Seller Group Members to amend one of the regulatory milestones beyond December 31, 2021. This regulatory milestone was subsequently
achieved on January 14, 2022 when the Company received 510(k) clearance for its HOLO Portal™
surgical guidance system. Upon achievement of this milestone, the Company issued 288,333 shares
of its common stock at a value of $5.9 million, and paid the sellers $4.1 million in cash for a total payment for achieving the milestone
of $10.0 million.
The
Company determined the fair value of the Holo Milestone Payments to be the present value of each future payment amount estimated using
a probability weighted model, driven by the probability of success factor and expected payment date. The probability of success factor
was used in the fair value calculation to reflect inherent regulatory, development and commercial risk of the Holo Milestone Payments.
More specifically, the probability of success factor included the probability of: expected achievement of the specific milestones, including
risks associated with the uncertainty regarding the achievement and payment of milestones; obtaining regulatory approvals in the United
States and Europe; the development of new features used with the product; the adaption of the new technology by surgeons; and the placement
of the devices within the field. This fair value measurement is based on significant unobservable inputs in the market and thus represents
a Level 3 measurement within the fair value hierarchy.
Inputs
used in estimating the fair value of the contingent consideration for Holo Surgical as of June 30, 2023 and December 31, 2022, are summarized
below:
Fair
Value at June 30, 2023 | | |
Valuation
Technique | |
Unobservable
Inputs | |
Ranges | |
$ | 22,995 | | |
Earn-Out Valuation | |
Probability
of success factor | |
| 0%
- 95 | % |
| | | |
| |
Discount rates | |
| 13.09%
- 13.80 | % |
Fair
Value at December 31, 2022 | | |
Valuation
Technique | |
Unobservable
Inputs | |
Ranges | |
$ | 24,061 | | |
Earn-Out Valuation | |
Probability
of success factor | |
| 0%
- 95 | % |
| | | |
| |
Discount rates | |
| 13.09%
- 13.80 | % |
The
following table provides a reconciliation of contingent consideration measured at fair value using significant unobservable inputs (Level
3) as of June 30, 2023 and December 31, 2022:
| |
June 30, 2023 | | |
December 31, 2022 | |
Beginning balance as of January 1 | |
$ | 24,061 | | |
$ | 51,928 | |
Gain on acquisition contingency | |
| (1,066 | ) | |
| (17,867 | ) |
Milestone payments | |
| — | | |
| (10,000 | ) |
Ending balance | |
$ | 22,995 | | |
$ | 24,061 | |
Property
and Equipment, Intangibles and Other Assets
As
of June 30, 2023, and December 31, 2022, respectively, property and equipment with a carrying amount of $2.9 million and $6.0 million
were written down to their estimated fair value of $2.4 million and $2.3 million using Level 3 inputs. The Level 3 fair value was measured
based on orderly liquidation value and is evaluated on a quarterly basis. Unobservable inputs for the orderly liquidation value included
replacement costs, physical deterioration estimates and market sales data for comparable assets.
Definite-lived
intangible and other assets subject to amortization were impaired and written down to their estimated fair values in 2023 and 2022. Fair
value is measured as of the impairment date using Level 3 inputs. Definite-lived intangible assets and other assets’ fair value
was measured based on the income approach and orderly liquidation value, respectively. Due to the Company’s forecasted cash flow
being negative, any intangible assets acquired during the period were immediately impaired. Unobservable inputs for the orderly liquidation
value included replacement costs, physical deterioration estimates and market sales data for comparable assets. Unobservable inputs for
the income approach included forecasted cash flows generated from use of the definite-lived intangible assets.
As
a result of impairments recognized, the following table summarizes the post impairment fair values of the corresponding assets subject
to fair value measured using Level 3 inputs as of June 30, 2023 and December 31, 2022:
Net Book Value | |
June 30, 2023 | | |
December 31, 2022 | |
Property and equipment – net | |
$ | 2,421 | | |
$ | 2,316 | |
Other assets – net | |
| 5,713 | | |
| 5,527 | |
| |
$ | 8,134 | | |
$ | 7,843 | |
Property
and equipment was impaired and written down to their estimated fair values during the six months ended June, 2023 and 2022. Other intangible
assets and other assets were impaired and written down to their estimated fair values during the six months ended June 30, 2023 and 2022.
The following table summarizes the corresponding impairment charge during the six months ended June 30, 2023 and 2022:
| |
For the Six Months Ended June 30, | |
Impairment | |
2023 | | |
2022 | |
Property and equipment – net | |
$ | 486 | | |
$ | 1,573 | |
Definite-lived intangible assets – net | |
| 35 | | |
| 201 | |
Other assets – net | |
| 32 | | |
| 161 | |
| |
$ | 553 | | |
$ | 1,935 | |
During
the six months ended June 30, 2023 and 2022, the Company concluded, through its ASC 360 impairment testing of long-lived assets classified
as held and used, that factors existed indicating that finite-lived intangible assets were impaired. The factors considered by management
include a history of net losses and negative cash flows in each of those periods to be able to support the assets. The Company tested
the carrying amounts of the property and equipment, definite lived intangibles, and other assets for impairment. As a result, we recorded
an impairment charge of $0.6 million and $1.9 million for the six months ended June 30, 2023 and 2022 which was recorded within the “Asset
impairment and abandonments” line item on the condensed consolidated statement of comprehensive income.
Warrant
Liability
Warrants
are accounted for as liabilities in accordance with ASC 815-40 and are presented within “Warrant liability” in the Company’s
condensed consolidated balance sheets.
The
following table presents information about the Company’s liabilities that are measured at fair value:
| |
Level | | |
June 30, 2023 | | |
December 31, 2022 | |
Warrant liability | |
| 3 | | |
$ | — | | |
$ | 22,982 | |
| |
Level | | |
March 31, 2023 | | |
December 31, 2022 | |
Warrant liability | |
| 3 | | |
$ | 15,512 | | |
$ | 22,982 | |
June
14, 2021 Warrants
The
table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the June 14, 2021 warrant
liability as of June 30, 2023 and December 31, 2022:
| |
June 30, 2023 | | |
December 31, 2022 | |
Beginning balance as of January 1 | |
$ | 13 | | |
$ | 12,013 | |
Change in fair value of restricted warrants (1) | |
| — | | |
| 866 | |
Transfer of warrants (2) | |
| — | | |
| (929 | ) |
Change in fair value of warrant liability | |
| (13 | ) | |
| (11,937 | ) |
Ending balance | |
$ | — | | |
$ | 13 | |
The
warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying condensed consolidated
statements of comprehensive income until the warrants are exercised or expire. The fair value of the warrant liability is estimated using
the Black-Scholes Option Pricing Model using the following valuation inputs:
February
15, 2022 Warrants
| |
June 30, 2023 | | |
December 31, 2022 | |
Stock price | |
$ | 0.00 | | |
$ | 1.99 | |
Risk-free interest rate | |
| 4.52 | % | |
| 4.53 | % |
Dividend yield | |
| — | | |
| — | |
Volatility | |
| 110 | % | |
| 110 | % |
The
table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the February 15, 2022 warrant
liability as of June 30, 2023 and December 31, 2022:
| |
June 30, 2023 | | |
December 31, 2022 | |
Beginning balance as of January 1 | |
$ | 442 | | |
$ | — | |
Fair value of warrants on date of issuance | |
| — | | |
| 10,157 | |
Change in fair value of restricted warrants (1) | |
| — | | |
| 448 | |
Transfer of warrants (2) | |
| — | | |
| (1,064 | ) |
Redemption of shares | |
| — | | |
| (1,749 | ) |
Change in fair value of warrant liability | |
| (442 | ) | |
| (7,350 | ) |
Ending balance | |
$ | — | | |
$ | 442 | |
The
warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying condensed consolidated
statements of comprehensive income until the warrants are exercised or expire. The fair
value of the warrant liability is estimated using the Black-Scholes Option Pricing Model using the following valuation inputs:
| |
June 30, 2023 | | |
December 31, 2022 | |
Stock price | |
$ | 0.00 | | |
$ | 1.99 | |
Risk-free interest rate | |
| 3.62 | % | |
| 4.05 | % |
Dividend yield | |
| — | | |
| — | |
Volatility | |
| 95 | % | |
| 95 | % |
November
13, 2022 Warrants
The
tables presented below are a summary of changes in the fair value of the Company’s Level 3 valuation for the November 13, 2022
warrant liability as of June 30, 2023 and December 31, 2022:
| |
June 30, 2023 | |
| |
Pre-funded Warrants | | |
Series A Warrants | | |
Series B Warrants | | |
Placement Agent Warrants | |
Beginning balance as of March 31 | |
$ | 5,805 | | |
$ | 7,672 | | |
$ | 1,455 | | |
$ | 355 | |
Change in fair value of warrant liability | |
| (5,805 | ) | |
| (7,672 | ) | |
| (1,455 | ) | |
| (355 | ) |
Ending balance as of June 30 | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
| |
December 31, 2022 | |
| |
Pre-funded Warrants | | |
Series A Warrants | | |
Series B Warrants | | |
Placement Agent Warrants | |
Beginning balance as of October 1 | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
Fair value of warrants on date of issuance | |
| 12,724 | | |
| 10,671 | | |
| 2,570 | | |
| 596 | |
Transfer of warrants | |
| — | | |
| 1,993 | | |
| — | | |
| — | |
Redemption of shares | |
| (487 | ) | |
| — | | |
| — | | |
| — | |
Change in fair value of warrant liability | |
| (2,434 | ) | |
| (2,421 | ) | |
| (570 | ) | |
| (115 | ) |
Ending balance as of December 31 | |
$ | 9,803 | | |
$ | 10,243 | | |
$ | 2,000 | | |
$ | 481 | |
The
warrant liability is revalued each reporting period with the change in fair value recorded in the accompanying consolidated statements
of comprehensive income until the warrants are exercised or expire. The fair value of the
warrant liability is estimated using the Black-Scholes Option Pricing Model using the following valuation inputs:
| |
June 30, 2023 | |
| |
Pre-funded Warrants | | |
Series A Warrants | | |
Series B Warrants | | |
Placement Agent Warrants | |
Stock price | |
$ | 0.0 | | |
$ | 0.0 | | |
$ | 0.0 | | |
$ | 0.0 | |
Risk-free interest rate | |
| N/A | | |
| 3.68 | % | |
| 3.90 | % | |
| 3.68 | % |
Dividend yield | |
| N/A | | |
| — | | |
| — | | |
| — | |
Volatility | |
| N/A | | |
| 90 | % | |
| 105 | % | |
| 90 | % |
Accrued
expenses are as follows:
| |
June 30, 2023 | | |
December 31, 2022 | |
Accrued compensation | |
$ | 5,282 | | |
$ | 3,614 | |
Accrued distributor commissions | |
| 2,896 | | |
| 3,801 | |
Accrued severance and restructuring costs | |
| 669 | | |
| 1,041 | |
Other | |
| 3,243 | | |
| 4,690 | |
Total accrued expenses | |
$ | 12,090 | | |
$ | 13,146 | |
13. |
Other Long-term Liabilities |
Other
long-term liabilities are as follows:
| |
June 30, 2023 | | |
December 31, 2022 | |
Lease obligations | |
$ | 1,213 | | |
$ | 1,142 | |
Retention credit | |
| 3,222 | | |
| 3,222 | |
Other | |
| 3,471 | | |
| 3,219 | |
Total other long-term liabilities | |
$ | 7,906 | | |
$ | 7,583 | |
The
Company evaluates the need for deferred tax asset valuation allowances based on a more likely than not standard. The ability to realize
deferred tax assets depends on the ability to generate sufficient taxable income within the carryback or carryforward periods provided
for in the tax law for each applicable tax jurisdiction. The Company has evaluated all evidence, both positive and negative, and maintains
a valuation allowance on deferred tax assets in the United States and certain non-U.S. jurisdictions as of June 30, 2023.
For
the six months ended June 30, 2023 and 2022, the Company recorded income tax provision of $0.1 million and $0.3 million, respectively
in continuing operations. The June 30, 2023 six-month income tax provision was primarily a result of non-U.S. income tax expense, interest
accrued on uncertain tax positions, and state tax notices received. The June 30, 2022 income tax provision was primarily a result of
federal tax notices received, non-U.S. income tax expense, and interest accrued on uncertain tax positions.
On
December 30, 2021, the Company issued $10.6 million aggregate principal amount of unsecured seller notes (“Seller Notes”)
recorded at $10.2 million and $10.2 million as of June 30, 2023 and December 31, 2022 respectively. All principal and accrued interest
is due and payable on the earlier of December 30, 2024, or the date upon which a change in control occurs. A change of control occurs
when (i) the current shareholders of the Company will no longer own a majority of the outstanding voting shares of the Company due to
a transaction or series of related transactions, or (ii) a sale or transfer of Holo Surgical Inc and Inteneural Networks Inc. or all
or substantially all of their assets. Interest is paid in kind and capitalized into the principal amount of the Seller Notes on each
anniversary of the issuance date at a rate of 6.8% per year. For the six months ended June 30, 2023, management accrued $0.1 million
in interest expense and accredited $0.2 million related to the Seller Notes for a total interest expense of $0.3 million. In the event
of default, as defined in the agreement, any and all of the indebtedness may be immediately declared due and payable, and the interest
would accrue at a 4.0% higher rate. There is no prepayment penalty or covenant related to the fixed rate notes. The Seller Notes were
issued as deferred consideration in connection with the INN Purchase Agreement discussed at Note 1 and Note 5.
Debt
issuance costs were immaterial and were included within the overall costs of the acquisition of INN. The following table summarizes the
debt recorded on the condensed consolidated balance sheet:
| |
Carrying Value (In thousands) | |
| |
June 30, 2023 | | |
December 31, 2022 | |
Seller Notes-P. Lewicki | |
$ | 5,306 | | |
| 5,306 | |
Seller Notes-K. Siemionow | |
| 5,306 | | |
| 5,306 | |
Less: accretion of acquisition adjustment | |
| (368 | ) | |
| (420 | ) |
Total Seller Notes – related party | |
| 10,244 | | |
| 10,192 | |
Current portion of seller notes | |
| — | | |
| — | |
Total long-term seller notes, excluding current portion | |
$ | 10,244 | | |
$ | 10,192 | |
The
fair value of the Seller Notes is $10.2 million and $10.2 million at June 30, 2023 and December 31, 2022, respectively. The Company has
determined that the Seller Notes are a level 2 financial instrument as there are other unobservable inputs.
As
of June 30, 2023, the future maturities of long-term debt, excluding deferred financing costs, accrued interest and debt discount, were
as follows:
| |
Future Maturities of Long-Term Debt | |
2023 | |
$ | — | |
2024 | |
| 10,612 | |
2025 | |
| — | |
2026 | |
| — | |
2027 | |
| — | |
Thereafter | |
| — | |
Total | |
$ | 10,612 | |
16. |
Commitments and Contingencies |
Aziyo
– On August 1, 2018, the Company and Aziyo Biologics, Inc. (“Aziyo”) entered into a Distribution Agreement
which was subsequently amended on December 3, 2018, and November 15, 2020 (the “Distribution Agreement”). Pursuant to the
Distribution Agreement, the Company has the exclusive right to distribute certain biologic implants manufactured by Aziyo and marketed
under the ViBone trade name (“ViBone”). The Distribution Agreement provides for minimum purchases of ViBone implants on an
annual basis through calendar 2025. For calendar years 2019-2021, if the minimum purchase obligations for a particular year are not fulfilled,
the Distribution Agreement provides various options for the Company to satisfy such obligations (“Shortfall Obligations”)
in subsequent years, including a combination of payments and/or providing purchase orders for the shortfall amount in a given year. If
a purchase order is submitted, the contract does not provide that it needs to be satisfied during the following year (i.e., the Company
can satisfy the orders over multiple years and until the minimum is achieved). For calendar years 2022 and beyond, if the Company does
not satisfy the Shortfall Obligations using one of the methods specified in the Distribution Agreement, the Company can continue to market
the ViBone implants on a non-exclusive basis. We did
not fulfill the minimum purchase obligation for calendar year 2022 and have not satisfied the Shortfall Obligation. As it relates to
the prior year minimums, we had previously issued a purchase order for the 2020 and 2021 minimums. The remaining amount on the purchase
order for both years combined is $15.1 million.
Acquisition
of Inteneural Networks Inc. (INN) – As part of the INN acquisition, the Company has the ability to acquire the remaining
58% equity interest in INN based on the achievement of three
separate regulatory and revenue based milestones. The Company will pay $19.3 million
for each individual milestone achieved, resulting in a corresponding additional 19.3% equity
interest in INN per milestone achieved. The total future commitment of the remaining three milestones is $57.9 million.
None of the milestones has been achieved as of June 30, 2023.
Acquisition
of Holo Surgical – As part of the Holo Surgical acquisition, the
Company issued contingent consideration that would be payable to the sellers upon the achievement of certain regulatory, commercial,
and utilization milestones by specified time periods. On January 14, 2022, the Company received 510(k) clearance for the HOLO PortalTM
surgical guidance system. Upon achievement of this milestone, the Company issued 288,333 in common stock at a value of $5.9 million and
also paid the sellers $4.1 million in cash for a total payment for achieving the milestone of $10.0 million pursuant to the terms of
the agreement. The fair value of the liability for these contingent considerations was $23.0 million
as of June 30, 2023 with $0.0 million classified as current liabilities within “Current
portion of acquisition contingency – Holo” while $23.0 million was classified
as “Acquisition contingencies – Holo.”
The fair value of the liability was $24.1 million on December 31, 2022 with $0.0 million classified as current liabilities within “Current
portion of acquisition contingency – Holo” while $24.1 million classified
as “Acquisition contingencies – Holo.”
The change in the fair value of the liability of $1.1 million since December 31, 2022 was recognized
in the “Gain on acquisition contingency” line of the condensed consolidated statements of comprehensive income.
Manufacturing
Agreements with Former OEM Affiliates – In connection with the closing of the OEM Transaction, on July 20, 2020 the Company
entered into three manufacturing and distribution agreements with affiliates of Montague Private Equity: (i) a Manufacture and Distribution
Agreement (the “Hardware MDA”) with Pioneer Surgical Technology, Inc. (“Pioneer”) pursuant to which Pioneer would
manufacture certain hardware implants for the Company; (ii) a Processing and Distribution Agreement with RTI Surgical, Inc. (“RTI”),
an affiliate of Pioneer, pursuant to which RTI would process certain biologic implants for the Company (the “PDA”); and (iii)
a Manufacture and Distribution Agreement with (“NanOss”) pursuant to which Pioneer would manufacture certain synthetic implants
for the Company (the “NanOss MDA”), and together with the Hardware MDA and the PDA, the “OEM Distribution Agreements.”
On August 5, 2022, the Company amended the OEM distribution agreement to reduce the Contract
Year 3 minimum to $17.9 million and released the Company from any obligation to cure any purchase shortfall in Contract Year 2. There
is no outstanding liability associated with the agreement as of June 30, 2023 and December 31,
2022.
License
and Royalty Commitments
The
Company has entered into product development and fee for service agreements based on contributions to the development and commercialization
of certain products. Each royalty agreement: (i) confirms the irrevocable transfer to the Company of all pertinent intellectual property
rights; (ii) sets the applicable royalty rate; (iii) sets the period of time during which royalties are payable; (iv) sets the parameters
for which the agreement may be terminated by either party; and (v) prohibits the payment of royalties on products sold to entities and/or
individuals with whom the surgeon advisor or any other surgeon advisor entitled to royalties is affiliated.
As
of June 30, 2023 and 2022, the Company’s royalty agreements provide for (i) royalty
payments for 7 years from first commercial sale of the relevant product and (ii) a royalty rate for each such agreement ranging from
1.0% to 10.0% of net sales for the particular product to which the surgeon contributed. Related royalty expenses are recorded within
“Cost of goods sold” on the consolidated statements of comprehensive income.
17. |
Severance and Restructuring Costs |
On
November 8, 2022, the Board approved a restructuring plan intended to help the Company drive growth in what it views to be the most valuable
and profitable parts of its business (Digital Health and core hardware assets). The restructuring plan includes brand and product portfolio
rationalization in the domestic markets, a scaled-down international business with operations winding down throughout 2023, a reduction
in workforce and reduced non-essential spending. The Company began executing on the restructuring plan in December 2022 and continued
the efforts in the first quarter of 2023. Regarding the product portfolio rationalization, the Company wrote down inventory held internationally
of $0.7 million during the six months ended June 30, 2023 because it was determined through continual assessment that select inventory
would not be sold during the quarter. This charge is reflected within the “Cost of goods sold” line in the condensed consolidated
statement of income. The majority of the product rationalization has occurred; the reduction in the workforce was executed in December
of 2022; and the plans for the scale back of the international business are currently being executed. The Company expects to continue
its efforts through the first half of 2023.
In
total, the Company expects to incur approximately $5.5 million - $7.5 million in costs related to severance and reduction in non-essential
spending throughout the execution of the restructuring plan. All severance payments accrued as of December 31, 2022 have been paid as
of June 30, 2023. The Company anticipates estimated cash savings in 2023 of approximately $30.0 million - $35.0 million as compared to
2022.
A
summary of the total restructuring costs by major component recognized for the six months ended June 30, 2023 is as follows:
| |
Employee-Related | | |
Product Rationalization | | |
Total | |
Six months ended June 30, 2023 | |
| — | | |
$ | 730 | | |
$ | 730 | |
| |
Employee-Related | | |
Product Rationalization | | |
Total | |
Incurred during the quarter ended December 31, 2022 | |
$ | 1,148 | | |
$ | 13,822 | | |
$ | 14,970 | |
Paid | |
| (107 | ) | |
| — | | |
| (107 | ) |
Non-cash adjustment (1) | |
| — | | |
| (13,822 | ) | |
| (13,822 | ) |
Balance as of December 31, 2022 | |
$ | 1,041 | | |
$ | — | | |
$ | 1,041 | |
Incurred during 2023 | |
| — | | |
| 730 | | |
| 730 | |
Paid | |
| (763 | ) | |
| — | | |
| (763 | ) |
Non-cash adjustment (1) | |
| — | | |
| (730 | ) | |
| (730 | ) |
Balance as of June 30, 2023 | |
$ | 278 | | |
$ | — | | |
$ | 278 | |
The
Company is, from time to time, involved in litigation relating to claims arising out of its operations in the ordinary course of business.
Based on the information currently available to the Company, including the availability of coverage under its insurance policies, except
as described below and in Note 19, the Company does not believe that any of these claims that were outstanding as of June 30, 2023 will
have a material adverse impact on its financial position or results of operations. The Company’s accounting policy is to accrue
for legal costs as they are incurred.
Coloplast
— RTI Surgical, Inc., as a predecessor to the Company, is presently named as co-defendant along with other companies in
a small percentage of the transvaginal surgical mesh (“TSM”) mass tort claims being brought in various state and federal
courts. The TSM litigation has, as its catalyst, various Public Health Notifications issued by the FDA with respect to the placement
of certain TSM implants that were the subject of 510(k) regulatory clearance prior to their distribution. The Company does not process
or otherwise manufacture for distribution in the U.S. any implants that were the subject of these FDA Public Health Notifications. The
Company denies any allegations against it and intends to continue to vigorously defend itself.
In
addition to claims made directly against the Company, Coloplast, a distributor of TSM’s and certain allografts processed and private
labeled for them under a contract with the Company, has also been named as a defendant in individual TSM cases in various federal and
state courts. Coloplast requested that the Company indemnify or defend Coloplast in those claims that allege injuries caused by the Company’s
allograft implants, and on April 24, 2014, Coloplast sued RTI Surgical, Inc. in the Fourth Judicial District of Minnesota for declaratory
relief and breach of contract. On December 11, 2014, Coloplast entered into a settlement agreement with RTI Surgical, Inc. and Tutogen
Medical, Inc. (the “Company Parties”) resulting in dismissal of the case. Under the terms of the settlement agreement, the
Company Parties are responsible for the defense and indemnification of two categories of present and future claims: (1) tissue only (where
Coloplast is solely the distributor of Company-processed allograft tissue and no Coloplast-manufactured or distributed synthetic mesh
is identified) (“Tissue Only Claims”), and (2) tissue plus non-Coloplast synthetic mesh (“Tissue-Non-Coloplast Claims”)
(the Tissue Only Claims and the Tissue-Non-Coloplast Claims being collectively referred to as “Indemnified Claims”).
Based
on the current information available to the Company, the impact that current or any future TSM litigation may have on the Company cannot
be reasonably estimated.
LifeNet
— On June 27, 2018, LifeNet Health, Inc. (“LifeNet”) filed a patent infringement lawsuit in the United States
District Court for the Middle District of Florida (since moved to the Northern District of Florida) claiming infringement of five of
its patents by the Company’s predecessor RTI Surgical, Inc. The suit requests damages, enhanced damages, reimbursement of costs
and expenses, reasonable attorney fees, and an injunction. The asserted patents are expired. On April 7, 2019, the Court granted the
Company’s request to stay the lawsuit pending the U.S. Patent Trial and Appeal Board’s (“PTAB”) decision whether
to institute review of the patentability of LifeNet’s patents. On August 12, 2019 the PTAB instituted review of three LifeNet patents,
and on September 3, 2019, the PTAB instituted review of the remaining two. On August 4, 2020 and August 26, 2020, the PTAB issued final
written decisions finding that certain claims were shown to be unpatentable and others not. Neither party appealed the PTAB’s decisions
with respect to the three LifeNet patents on which the PTAB instituted review on August 12, 2019. With respect to the remaining two LifeNet
patents, Surgalign filed Notices of Appeal with the Federal Circuit on October 27, 2020, and LifeNet filed a Notice of Cross-appeal on
November 9, 2020. The Federal Circuit issued a Written Opinion on April 11, 2022 affirming in part
and remanding in part. The PTAB canceled all challenged claims of the patent on remand on December 1, 2022. LifeNet filed a Notice of
Appeal with the Federal Circuit on January 12, 2023. The Court lifted the stay for counts related to 4 of the 5 patents on January 20,
2023 and severed the count relating to the patent claims canceled by the PTAB on December 1, 2022. A trial date has been set for July
22, 2024. In connection with the sale of the Company’s OEM Business, liabilities related to these claims remained a liability retained
by the Company. The Company continues to believe that the suit is without merit and will vigorously defend its position. The Company
has entered into preliminary settlement discussions with LifeNet, but at this time an estimate of the settlement cannot be estimated,
and therefore no amounts have been recorded as of June 30, 2023. Additionally based on the current information available to the Company,
the impact that current or any future litigation may have on the Company cannot be reasonably estimated.
Securities
Class Action— The Company’s Investigation (as defined below) resulted in stockholder litigation against the Company
and certain former officers of the Company in the United States District Court for the Northern District of Illinois (the “Court”)
on March 23, 2020 asserting claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”).
On June 30, 2021, the parties to the Lowry Action conducted a mediation session and on July 27, 2021, a binding term sheet settling the
Lowry Action was entered into whereby the defendants agreed to pay $10.5 million (inclusive of attorneys’ fees and administrative
costs) in exchange for the dismissal with prejudice of all claims. On September 22, 2021, the court granted preliminary approval to the
settlement, and the amount was paid by the Company’s insurers under its Directors’ and Officers’ insurance policies.
The Court entered an order approving the settlement on January 26, 2022 and no amounts were outstanding on June
30, 2023. The matter is now concluded.
Derivative
Lawsuits—Three derivative lawsuits have also been filed on behalf of the Company, naming it as a nominal defendant, and
demanding a jury trial. On June 5, 2020, David Summers filed a shareholder derivative lawsuit (the “Summers Action”) against
certain current and former directors and officers of the Company (as well as the Company as a nominal defendant), in the United States
District Court for the Northern District of Illinois asserting statutory claims under Sections 10(b), 14(a), and 20(a) of the Exchange
Act, as well as common law claims for breach of fiduciary duty, unjust enrichment and corporate waste. Thereafter, two similar shareholder
derivative lawsuits asserting many of the same claims were filed in the same court against the same current and former directors and
officers of the Company (as well as the Company as a nominal defendant), as well as a books and records demand under Section 220 of the
Delaware General Corporate Law (the “Books and Records Demand”). The three derivative lawsuits have been consolidated into
the first-filed Summers Action (together with the Books and Records Demand, the “Derivative Actions”). On September 6, 2020,
the court entered an order staying the Summers Action pending resolution of the motions to dismiss in the Lowry Action. On September
30, 2021, the court granted preliminary approval of a proposed settlement of the Derivative Actions (the “Derivative Actions Settlement”).
Pursuant to the Derivative Actions Settlement, the Company agreed to adopt or revise certain corporate governance policies and procedures,
and the Company’s insurers agreed to pay $1.5 million to plaintiffs’ counsel. On January 24, 2022, the court gave final approval
to the Derivative Actions Settlement and all amounts were settled. The matter is now concluded and no amounts were outstanding at June
30, 2023.
GPV
I FIZN and StartVenture@Poland Sp. z.o.o. ASI SKA — The Company is presently named as a co-defendant along with other companies
and individuals, including Dr. Siemionow and Dr. Lewicki, our former Chief Medical Officer and former Director respectively, by former
stockholders of Holo Surgical, S.A. (“Holo SA”), individually and/or collectively, for common law fraud, constructive fraud,
fraudulent inducement, conspiracy to defraud, and unjust enrichment, unlawful taking and conversion based on illegal and fraudulent actions
related to (i) the sale of shares in Holo Surgical, Inc. to Roboticine, (ii) the purchase of Plaintiffs’ ownership interests in
Holo SA by Roboticine, and (iii) the subsequent sale of Holo Surgical, Inc. to the Company. The Company does not believe that any of
the claims relate to its action with regard to the negotiations nor the purchase of Holo SA and on May 27, 2022, moved to dismiss. On
February 7, 2023, the court granted the Company’s motion to dismiss and the deadline for appeal has passed. The matter is now concluded.
In
the future, we may become subject to additional litigation or governmental proceedings or investigations that could result in additional
unanticipated legal costs regardless of the outcome of the litigation. If we are not successful in any such litigation, we may be required
to pay substantial damages or settlement costs. Based on the current information available to the Company, the impact that current or
any future stockholder litigation may have on the Company cannot be reasonably estimated.
SEC
Investigation— As previously disclosed in the Company’s Current Report on Form 8-K filed with the SEC on March 16,
2020, and the Form 10-K filed with the SEC on June 8, 2020, the Audit Committee of the Board of Directors, with the assistance of independent
legal and forensic accounting advisors, conducted an internal investigation of matters relating to the Company’s revenue recognition
practices for certain contractual arrangements, primarily with customers of the Company’s formerly-owned OEM Businesses, including
the accounting treatment, financial reporting and internal controls related to such arrangements (the “Investigation”). The
Investigation also examined transactions to understand the practices related to manual journal entries for accrual and reserve accounts.
As a result of the Investigation, the Audit Committee concluded that the Company would restate its previously issued audited financial
statements for fiscal years 2018, 2017, and 2016, selected financial data for fiscal years 2015 and 2014, the condensed consolidated
financial statements for the quarterly periods within these years commencing with the first quarter of 2016, as well as the condensed
consolidated financial statements for the quarterly periods within the 2019 fiscal year.
On
August 3, 2022, the Company reached a settlement with the SEC concluding and resolving in its entirety the Investigation. Under the terms
of the settlement, the Company paid a civil penalty of $2.0 million and received $0.6 million from former executives related to recouped
compensation. These amounts were recorded in previous years. For the Investigation, there were no amounts outstanding as of June 30,
2023.
20. |
Related Party Transactions |
The
Company’s related parties include: i) a person who is or was (since the beginning of the last fiscal year for which the Company
has filed a Form 10-K and proxy statement, even if he or she does not presently serve in that role) an executive officer, director or
nominee for election as a director; ii) greater than five percent beneficial owner of the Company’s common stock; or iii) immediate
family member of any of the foregoing. The Company is not aware of any related party transactions in 2023 to date.
The
Company evaluated subsequent events as of the issuance date of the condensed consolidated financial statements as defined by FASB ASC
855, Subsequent Events.
Exhibit
99.2
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
The
following unaudited pro forma condensed combined financial statements present the combination of the historical financial statements
of Xtant Medical Holdings, Inc., a Delaware corporation (“Xtant” or the “Company”), and Surgalign Holdings, Inc.
(“Surgalign Holdings”), a Delaware corporation, adjusted to give effect to the transaction contemplated by the Asset Purchase
Agreement dated June 18, 2023 between Xtant and Surgalign Holdings (as amended the “Purchase Agreement”), pursuant to which,
subject to the terms and conditions set forth in the Purchase Agreement, Xtant acquired certain assets of Surgalign Holdings and its
subsidiaries used in Surgalign Holding’s hardware and biologics business. The acquired assets
included specified inventory, intellectual property and intellectual property rights, contracts, records and outstanding equity
securities of its international subsidiaries, and intangibles related to Surgalign Holding’s
hardware and biologics business (collectively, the “Assets”), and Xtant assumed certain specified liabilities of Surgalign
Holdings and its subsidiaries (collectively, the “Liabilities” and such acquisition of the Assets and assumption of the Liabilities
together, the “Transaction”) for a total purchase price of $5 million in cash. The Transaction was completed on August 10,
2023.
The
Transaction was conducted through a process supervised by the United States Bankruptcy Court for the Southern District of Texas, Houston
Division in connection with Surgalign Holdings’s bankruptcy, and therefore Xtant acquired the Assets with limited representations
and warranties.
The
Transaction is reflected in the pro forma condensed combined financial statements in accordance with Financial Accounting Standards Board
(“FASB”) Accounting Standards Codification (“ASC”) 805, Business Combinations, and FASB ASC 350, Intangibles
– Goodwill and Other. Based on the terms of the Purchase Agreement, Xtant was determined to be the acquirer for accounting
purposes and the Transaction was accounted for under the acquisition method in accordance with FASB ASC 805, Business Combinations,
and FASB ASC 350, Intangibles—Goodwill and Other, using the fair value concepts defined in FASB ASC 820, Fair Value Measurements
and Disclosures.
The
unaudited pro forma condensed combined financial statements have been prepared in accordance with Article 11 of Regulation S-X, Pro Forma
Financial Information, as amended by the final rule, Release No. 33-10786 “Amendments to Financial Disclosures about Acquired
and Disposed Businesses”, which is herein referred to as “Article 11”. Article 11 provides simplified requirements
to depict the accounting for the Transaction (“Transaction Accounting Adjustments”) and the option to present the reasonably
estimable synergies and other Transaction effects that have occurred or are reasonably expected to occur (“Management’s Adjustments”).
The Company has elected not to present Management’s Adjustments in the unaudited pro forma condensed combined financial statements.
The
unaudited pro forma condensed combined statement of operations for the year ended December 31, 2023 gives effect to the Transaction as
if it had occurred on January 1, 2023, the beginning of the earliest period presented.
The
unaudited pro forma condensed combined financial statements should be read in conjunction with Xtant’s separately filed historical
consolidated financial statements and the historical Surgalign Holdings financial statements and accompanying notes filed as Exhibit
99.1 to the Current Report on Form 8-K to which these unaudited pro forma condensed combined financial statements are filed as an exhibit.
The pro forma adjustments are preliminary and are based upon available information and certain assumptions, as described in the accompanying
notes to the unaudited pro forma condensed combined financial statements, which the Company believes are reasonable under the circumstances.
Actual
results and valuations may differ materially from the assumptions within the unaudited pro forma condensed combined financial statements.
The unaudited pro forma condensed combined financial statements are not necessarily indicative of the financial position or results of
operations to be expected in future periods or the results that actually would have been realized had the Transaction occurred during
the specified periods and do not give effect to the potential impact of current financial condition, regulatory matters, operating efficiencies
or other savings or expenses that may be associated with the Transaction. The unaudited pro forma condensed combined financial information
is presented for illustrative purposes only and may not be indicative of the results of operations or financial condition of the combined
company following the Transaction.
Unaudited
Pro Forma Condensed Combined Statement of Operations
For
the Year Ended December 31, 2023
(In
thousands)
| |
Xtant
(Historical) | | |
Surgalign
Holdings,
Inc.
(Historical) | | |
Adjustments to
Surgalign
Holdings’s
Historical
Financial
Statements
(See Note 4) | | |
Transaction
Accounting
Adjustments | | |
Notes | |
Pro
Forma
Combined | |
Revenue | |
$ | 91,303 | | |
$ | 34,989 | | |
$ | (59 | ) | |
$ | — | | |
| |
$ | 126,233 | |
Cost of sales | |
| 35,836 | | |
| 11,718 | | |
| — | | |
| 144 | | |
(a) | |
| 47,698 | |
Gross Profit | |
| 55,467 | | |
| 23,271 | | |
| (59 | ) | |
| (144 | ) | |
| |
| 78,535 | |
| |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | | |
| |
| | |
General and administrative | |
| 25,850 | | |
| 45,172 | | |
| (9,746 | ) | |
| 271 | | |
(b) | |
| 61,547 | |
Sales and marketing | |
| 38,439 | | |
| — | | |
| — | | |
| — | | |
| |
| 38,439 | |
Research and development | |
| 1,336 | | |
| 5,873 | | |
| (2,763 | ) | |
| — | | |
| |
| 4,446 | |
Severance and restructuring costs | |
| — | | |
| 932 | | |
| (466 | ) | |
| — | | |
| |
| 466 | |
Gain on acquisition contingency | |
| — | | |
| (1,066 | ) | |
| 1,066 | | |
| — | | |
| |
| — | |
Asset impairment and abandonments | |
| — | | |
| 637 | | |
| (84 | ) | |
| — | | |
| |
| 553 | |
Transaction and integration expenses | |
| — | | |
| 463 | | |
| (463 | ) | |
| — | | |
| |
| — | |
Total Operating Expenses | |
| 65,625 | | |
| 52,011 | | |
| (12,456 | ) | |
| 271 | | |
| |
| 105,180 | |
| |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Gain on Sale of Coflex | |
| — | | |
| (12,631 | ) | |
| 12,631 | | |
| | | |
| |
| — | |
(Loss) Income from Operations | |
| (10,158 | ) | |
| (16,109 | ) | |
| (234 | ) | |
| (415 | ) | |
| |
| (26,916 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Other Income (Expense) | |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Interest expense | |
| 2,938 | | |
| 506 | | |
| (252 | ) | |
| — | | |
| |
| 3,192 | |
Interest income | |
| (149 | ) | |
| — | | |
| — | | |
| — | | |
| |
| (149 | ) |
Foreign exchange gain | |
| (265 | ) | |
| (619 | ) | |
| (73 | ) | |
| — | | |
| |
| (957 | ) |
Other expense (income) -net | |
| 49 | | |
| (323 | ) | |
| 87 | | |
| — | | |
| |
| (187 | ) |
Change in fair value of warrant liability | |
| — | | |
| (20,800 | ) | |
| 5,288 | | |
| — | | |
| |
| (15,512 | ) |
Bargain purchase gain | |
| (11,694 | ) | |
| — | | |
| — | | |
| — | | |
| |
| (11,694 | ) |
Total Other Expense | |
| (9,121 | ) | |
| (21,236 | ) | |
| 5,050 | | |
| — | | |
| |
| (25,307 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Net (Loss) Income from Operations Before Provision for Income Taxes | |
| (1,037 | ) | |
| 5,127 | | |
| (5,284 | ) | |
| (415 | ) | |
| |
| (1,609 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Provision for Income Taxes Current and Deferred | |
| (1,697 | ) | |
| 319 | | |
| (20 | ) | |
| — | | |
| |
| (1,398 | ) |
Net Income (Loss) | |
$ | 660 | | |
$ | 4,808 | | |
$ | (5,264 | ) | |
$ | (415 | ) | |
| |
$ | (211 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Net Loss Per Share: | |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Basic | |
$ | 0.01 | | |
$ | 0.60 | | |
| | | |
| | | |
| |
$ | 0.00 | |
Dilutive | |
$ | 0.01 | | |
$ | 0.55 | | |
| | | |
| | | |
| |
$ | 0.00 | |
| |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Shares used in the computation: | |
| | | |
| | | |
| | | |
| | | |
| |
| | |
Basic | |
| 119,093,687 | | |
| 8,072,339 | | |
| | | |
| | | |
| |
| 119,093,687 | |
Dilutive | |
| 126,793,318 | | |
| 8,766,184 | | |
| | | |
| | | |
| |
| 119,093,687 | |
See
notes to unaudited pro forma condensed combined financial statements.
NOTES
TO THE UNAUDITED PRO FORMA
CONDENSED
COMBINED FINANCIAL STATEMENTS
(In
thousands)
1. | Description
of the Transaction |
On
June 18, 2023, Xtant Medical Holdings, Inc. (“Xtant” or the “Company”) entered into an Asset Purchase Agreement
(the “Purchase Agreement”) with Surgalign Holdings, Inc. (“Surgalign Holdings”), pursuant
to which, subject to the terms and conditions set forth in the Purchase Agreement, Xtant agreed to acquire certain assets of Surgalign
Holdings and its subsidiaries on an as-is, where-is basis, including specified inventory, intellectual property and intellectual property
rights, contracts, equipment and other personal property, records, all outstanding equity securities of Surgalign Holdings’ international
subsidiaries, and intangibles related to the business of designing, developing and manufacturing hardware medical technology and distributing
biologics medical technology, as conducted by Surgalign Holdings and its subsidiaries (collectively, the “Assets”), and assume
certain specified liabilities of Surgalign Holdings and its subsidiaries (collectively, the “Liabilities” and such acquisition
of the Assets and assumption of the Liabilities together, the “Transaction”) for a total purchase price of $5 million in
cash. The Transaction was completed on August 10, 2023.
For
accounting purposes, the Transaction was accounted for under the acquisition method in accordance with Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) 805, Business Combinations, and FASB ASC 350,
Intangibles—Goodwill and Other.
2. | Basis
of Pro Forma Presentation |
The
unaudited pro forma condensed combined financial statements have been prepared in accordance with Article 11 of Regulation S-X and reflect
Transaction accounting adjustments management believes are necessary to present fairly Xtant’s pro forma results of operations
following the closing of the Transaction for the periods presented.
The
historical financial information of Xtant and Surgalign Holdings being presented in the unaudited pro forma financial statements is derived
from Xtant’s audited consolidated statement of operations for the year ended December 31, 2023, which were prepared in accordance
with accounting principles generally accepted in the United States (“U.S. GAAP”).
On
February 28, 2023, Xtant purchased all of the issued and outstanding shares of common stock of Surgalign SPV Inc. (“Surgalign SPV”),
an indirect, wholly owned subsidiary of Surgalign Holdings, which shares constituted all of the outstanding equity of Surgalign SPV,
for an aggregate purchase price of $17.0 million in cash. The historical financial information
of Surgalign SPV has been included within the historical financial information of Surgalign Holdings prior to the acquisition of February
28, 2023, within the pro forma unaudited condensed consolidated statement of operations for the year ended December 31, 2023 as
the acquired assets of Surgalign SPV, together with the Assets, were deemed to represent substantially all of Surgalign Holdings’s
key operating assets in accordance with Regulation S-X 3-05.
These
unaudited pro forma condensed combined financial statements are presented for illustrative purposes only and do not give effect to any
cost savings from operating efficiencies, revenue synergies, differences in stand-alone costs or costs for the integration of Surgalign
Holdings’s operations. These unaudited pro forma condensed combined financial statements do not purport to represent what the actual
consolidated results of operations of Xtant would have been had the Transaction been completed on the dates assumed, nor are they indicative
of future consolidated results of operations or consolidated financial position. Any transaction, separation or integration costs will
be expensed in the appropriate accounting periods after completion of the Transaction.
As
indicated in Note 5 to these unaudited pro forma condensed combined financial statements, management has made certain adjustments to
the historical book values of the assets acquired to reflect preliminary estimates of fair value necessary to prepare the unaudited pro
forma condensed combined financial statements, with the excess of the fair value of net assets acquired over the purchase price recorded
as a gain on bargain purchase. Actual results may differ from these unaudited pro forma condensed combined financial statements once
management has completed the valuation studies necessary to finalize the required purchase price allocations. There can be no assurance
that such finalization will not result in material changes. The preliminary unaudited pro forma purchase price allocation has been made
solely for preparing these unaudited pro forma condensed combined financial statements.
As
part of preparing these unaudited pro forma condensed combined financial statements, Management conducted a review of the accounting
policies of Surgalign Holdings to determine if differences in accounting policies require reclassification of results of operations or
reclassification of assets to conform to Xtant’s accounting policies and classifications. During the preparation of these unaudited
pro forma condensed combined financial statements, management did not become aware of any material differences between accounting policies
of Xtant and Surgalign Holdings.
The
unaudited pro forma condensed combined financial statements may not reflect all reclassifications necessary to conform Surgalign Holdings’s
presentation to that of Xtant due to limitations on the availability of information as of the date of the Current Report on Form 8-K
to which these unaudited pro forma condensed combined financial statements are filed as an exhibit.
4. | Adjustments
to Surgalign Holdings’s Historical Financial Statements |
These
adjustments are amounts in Surgalign Holdings’s historical statements of operations and historical balance sheet that relate to
revenue and expenses and assets and liabilities directly associated with a component not acquired by Xtant in the Transaction, and therefore,
are not included in the unaudited pro forma condensed combined statements of operations and the unaudited pro forma condensed combined
balance sheet.
5. | Purchase
Price Allocation |
Xtant
purchased certain Assets and certain Liabilities as described above of Surgalign Holdings, for a total purchase price of $5 million in
cash.
The
table below represents the allocation of the total consideration for Surgalign Holdings’s assets based on management’s estimate
of their respective fair values as of August 10, 2023, and is applied to the unaudited pro forma condensed combined balance sheet as
if the Transaction occurred on January 1, 2023 (in thousands):
Cash | |
$ | 1,087 | |
Accounts receivable | |
| 1,627 | |
Inventories | |
| 15,300 | |
Prepaids and other current assets | |
| 825 | |
Equipment | |
| 2,067 | |
Right-of-use-asset | |
| 576 | |
Accounts payable | |
| (530 | ) |
Accrued liabilities | |
| (1,170 | ) |
Current portion of lease liability | |
| (238 | ) |
Lease liability, less current portion | |
| (338 | ) |
Net assets acquired | |
| 19,206 | |
Bargain purchase gain | |
| (11,694 | ) |
Deferred tax liability | |
| (1,922 | ) |
| |
| | |
Total purchase consideration | |
$ | 5,590 | |
The
Transaction was recorded by allocating the costs of the net assets acquired based on their respective estimated fair values at the acquisition
date. The fair values were based on management’s analysis, including work performed by third-party valuation specialists.
6. | Transaction
Accounting Adjustments |
The
Transaction accounting adjustments are based on Xtant’s preliminary estimates and assumptions that are subject to change. The following
adjustments have been reflected in the unaudited pro forma condensed combined financial statements as if the Transaction occurred on
January 1, 2023:
| (a) | Inventory
and Cost of Sales |
Xtant
recorded additional cost of sales of $144 thousand in connection with the sell-through of inventory at the stepped-up fair value.
| (b) | Intangible
Amortization |
Reflects
the adjustments in connection with the recorded fair value, Xtant recorded additional intangible amortization expense of $271 thousand
for the year ended December 31, 2023.
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