2023 First Quarter and Subsequent Corporate Highlights:
- Launch of HOLO™ AI Insights for Spine Imaging; collaboration with Dr.
Alexander Vaccaro ,Dr. Pierce Nunley and Spine Institute of Louisiana , and leading neuro and orthopedic spine surgeons andSan Diego Spine Foundation . - Launch of HOLO AI Insights for
Neurovascular Research ; collaboration with Dr.Brian Jankowitz , a fellowship trained cerebrovascular neurosurgeon, for neurovascular research. - HOLO Portal™ Surgical Guidance System (“HOLO Portal”) upgrades unveiled; next generation software and new surgical tool integration to improve system functionality and drive further adoption.
- Two new sites added in
May 2023 for HOLO Portal; onboarding underway with cases to be scheduled. - HOLO Portal expansion into
Texas ; first case performed by Dr.Ripul Panchal , DO of Medical City Frisco, part of HCA Healthcare. - Sale of its Coflex® and CoFix™ product lines for
$17.0 million , raising net proceeds of$14.8 million .
“Throughout 2023, we have advanced our HOLO AI portfolio with an upgraded HOLO Portal system, and the launch of HOLO AI Insights for research-use for both spine imaging and neurovascular research,” stated
Financial Update
Total revenue for the three months ended
The Company reported gross margin of 63.7% for the three months ended
On a non-GAAP basis, the Company reported adjusted gross margin of 69.5% for the three months ended
Total operating expenses for the three months ended
On a non-GAAP basis, total adjusted operating expenses for the three months ended
The Company reported an operating loss of
Adjusted earnings before interest, taxes, depreciation, and amortization (Adjusted EBITDA) for the three months ended
As of
The Company continues to implement a corporate-wide review of its organizational structure, processes and costs, along with continued product rationalization initiatives. The restructuring plan began during the fourth quarter of 2022 and continues today.
Conference Call
About
Forward Looking Statements
This press release contains forward-looking statements based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management, and such forward-looking statements include (among others) statements regarding anticipated future financial and operating performance (including forecasted full-year revenue and number of HOLO sites secured), product rationalization and expense reduction initiatives and the results thereof, potential third party financing and anticipated cash needs. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “projects,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements are not guarantees of future performance and are based on certain assumptions including general economic conditions, as well as those within the Company’s industry, and numerous other factors and risks identified in the Company’s most recent Form 10-K, 10-Q and other filings with the
Investor and Media Relations Contact:
T: +1 (917) 887 8434
E: gwiener@gwcco.com
Condensed Consolidated Statements of Operations | ||||||||
(Unaudited, in thousands, except share and per share data) | ||||||||
For the Three Months Ended | ||||||||
2023 | 2022 | |||||||
Revenues | $ | 16,748 | $ | 20,605 | ||||
Cost of goods sold | 6,074 | 6,410 | ||||||
Gross profit | 10,674 | 14,195 | ||||||
Operating Expenses: | ||||||||
General and administrative | 21,127 | 25,317 | ||||||
Severance and restructuring costs | 466 | — | ||||||
Research and development | 2,905 | 4,447 | ||||||
Gain on acquisition contingency | (1,066 | ) | (8,503 | ) | ||||
Asset impairment and abandonments | 553 | 939 | ||||||
Transaction and financing expenses | 463 | 916 | ||||||
Total operating expenses | 24,448 | 23,116 | ||||||
Gain on sale of Coflex | (12,631 | ) | — | |||||
Operating loss | (1,143 | ) | (8,921 | ) | ||||
Other (income) expense - net | ||||||||
Other (income) expense - net | (147 | ) | 28 | |||||
Interest expense | 252 | 252 | ||||||
Foreign exchange (gain) loss | (238 | ) | 353 | |||||
Change in fair value of warrant liability | (5,288 | ) | (9,743 | ) | ||||
Total other (income) - net | (5,421 | ) | (9,110 | ) | ||||
Income before income tax provision | 4,278 | 189 | ||||||
Income tax provision | 133 | 162 | ||||||
Net income from operations | 4,145 | 27 | ||||||
Other comprehensive income (loss) | ||||||||
Unrealized foreign currency translation (gain) | (509 | ) | (109 | ) | ||||
Total other comprehensive income | $ | 4,654 | $ | 136 | ||||
Net income per common share - basic | $ | 0.51 | $ | 0.00 | ||||
Net (loss) income per common share - diluted | $ | (0.03 | ) | $ | 0.00 | |||
Weighted average shares outstanding - basic | 8,072,339 | 5,733,646 | ||||||
Weighted average shares outstanding - diluted | 13,320,439 | 5,910,719 |
Condensed Consolidated Balance Sheets | ||||||||
(Unaudited, in thousands) | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Cash | $ | 22,430 | $ | 16,295 | ||||
Accounts receivable - net | 12,575 | 16,057 | ||||||
Current inventories - net | 13,530 | 17,710 | ||||||
Prepaid and other assets | 4,895 | 6,649 | ||||||
Total current assets | $ | 53,430 | $ | 56,711 | ||||
Non-current inventories - net | 6,148 | 5,947 | ||||||
Property, plant and equipment - net | 2,421 | 2,057 | ||||||
Other assets - net | 5,713 | 5,527 | ||||||
Total assets | $ | 67,712 | $ | 70,242 | ||||
Liabilities, Mezzanine Equity and Stockholders' Equity | ||||||||
Accounts payable | $ | 7,492 | $ | 7,705 | ||||
Accrued expenses and other current liabilities | 12,090 | 13,146 | ||||||
Accrued income taxes | 402 | 296 | ||||||
Total current liabilities | $ | 19,984 | $ | 21,147 | ||||
Notes payable - related party | 10,244 | 10,192 | ||||||
Acquisition contingencies - Holo | 22,995 | 24,061 | ||||||
Warrant liability | 15,512 | 22,982 | ||||||
Other Long-term liabilities | 7,906 | 7,583 | ||||||
Total liabilities | $ | 76,641 | $ | 85,965 | ||||
Mezzanine equity | 10,006 | 10,006 | ||||||
Stockholders' equity: | ||||||||
Common stock and additional paid-in capital | 604,487 | 601,329 | ||||||
Accumulated other comprehensive loss | (3,349 | ) | (2,840 | ) | ||||
Accumulated deficit | (620,073 | ) | (624,218 | ) | ||||
Total stockholders' equity | $ | (18,935 | ) | $ | (25,729 | ) | ||
Total liabilities and stockholders' equity | $ | 67,712 | $ | 70,242 |
Condensed Consolidated Statements of Cash Flows | ||||||||
(Unaudited, in thousands) | ||||||||
For the Three Months Ended | ||||||||
2023 | 2022 | |||||||
Cash flows from operating activities: | ||||||||
Net income | $ | 4,145 | $ | 27 | ||||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||||||
Depreciation and amortization expense | 499 | 562 | ||||||
Provision for bad debts and product returns | 29 | 913 | ||||||
Investor fee | — | 916 | ||||||
Change in fair value of warrant liability | (5,288 | ) | (9,743 | ) | ||||
Provision for inventory write-downs | 215 | 3,044 | ||||||
Deferred income tax provision | (21 | ) | — | |||||
Stock-based compensation | 985 | 1,374 | ||||||
Asset impairment and abandonments | 553 | 939 | ||||||
Gain on acquisition contingency | (1,066 | ) | (8,503 | ) | ||||
Gain on sale of Coflex | (12,631 | ) | — | |||||
Other | (35 | ) | (3 | ) | ||||
Change in assets and liabilities: | ||||||||
Accounts receivable | 3,451 | (2,235 | ) | |||||
Inventories | 1,580 | (2,122 | ) | |||||
Accounts payable | (2,405 | ) | 1,771 | |||||
Accrued expenses | (826 | ) | (17,492 | ) | ||||
Right-of-use asset and lease liability | (360 | ) | (2 | ) | ||||
Other operating assets and liabilities | 2,153 | 11,416 | ||||||
Net cash used in operating activities | $ | (9,022 | ) | $ | (19,138 | ) | ||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (1,297 | ) | (1,261 | ) | ||||
Disposal of Coflex | 17,000 | — | ||||||
Patent and acquired intangible asset costs | (35 | ) | (81 | ) | ||||
Net cash provided by (used in) investing activities | $ | 15,668 | $ | (1,342 | ) | |||
Cash flows from financing activities: | ||||||||
Share offering proceeds including prefunded warrant exercised, net | — | 17,729 | ||||||
Payment of Holo Milestones - contingent consideration | — | (4,081 | ) | |||||
Pre-funded warrant execution | 1 | — | ||||||
Payments for treasury stock | (20 | ) | (5 | ) | ||||
Net cash (used in) provided by investing activities | $ | (19 | ) | $ | 13,643 | |||
Effect of exchange rate changes on cash and cash equivalents | (492 | ) | 227 | |||||
Net increase (decrease) in cash and cash equivalents | 6,135 | (6,610 | ) | |||||
Cash and cash equivalents, beginning of period | 16,295 | 51,287 | ||||||
Cash and cash equivalents, end of period | $ | 22,430 | $ | 44,677 |
Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements presented on a GAAP basis, we disclose non-GAAP net loss applicable to common shares, non-GAAP net loss per diluted share, non-GAAP operating expenses, and non-GAAP gross profit, in each case adjusted for certain amounts. In addition, we disclose EBITDA and Adjusted EBITDA, which are non-GAAP financial measures. The calculation of the tax effect on the adjustments between GAAP net loss applicable to common shares and non-GAAP net income applicable to common shares is based upon our estimated annual GAAP tax rate, adjusted to account for items excluded from GAAP net loss applicable to common shares in calculating non-GAAP net loss applicable to common shares. Reconciliations of each of these non-GAAP financial measures to the most directly comparable GAAP measures are included in the reconciliations below.
The following are explanations of the adjustments that management excluded as part of the non-GAAP measures for the three months ended
2023 and 2022 Non-cash stock-based compensation – These costs relate to expense amortization for all stock-based awards made to employees and directors, including restricted stock awards, restricted stock units, stock options and the employee stock purchase plan purchase rights.
2023 and 2022 Foreign exchange (gain) loss– These costs relate to the process of remeasuring international activity into the Company's functional currency.
2023 and 2022 Change in fair value of warrant liability – Other income related to the revaluation of our warrant liability.
2023 and 2022 Gain on acquisition contingency – The gain on acquisition contingency relates to an adjustment to our estimate of obligation for future milestone payments on the Holo Surgical acquisition.
2023 and 2022 Asset impairment and abandonments – These costs relate to asset impairment and abandonments of certain long-term assets within the asset group.
2023 and 2022 Transaction and financing expenses – These costs relate to professional fees associated with financings, issuance costs for the underwritten public offering, and service related to sale of the Company’s Coflex inventory line.
2023 and 2022 Inventory purchase price adjustment – These costs relate to the purchase price effects of acquired Paradigm inventory that was sold during the two months of January and February of 2023 prior to the sale of inventory line, and for the three months ended
2023 Severance and restructuring costs – These costs relate to employee related severance costs as a result of the Company’s organization restructuring plan.
2023 Gain on sale of Coflex – Gain related to the sale of the Company’s Coflex and Cofix product lines in
2023 Product rationalization – These costs relate to inventory write downs associated with the wind down of the international business.
Material Limitations Associated with the Use of Non-GAAP Financial Measures
EBITDA, Adjusted EBITDA and Adjusted Net Income Applicable to Common Shares should not be considered in isolation, or as a replacement for GAAP measures.
Usefulness of Non-GAAP Financial Measures to Investors
The Company believes that presenting EBITDA, Adjusted EBITDA and Adjusted Net Income Applicable to Common Shares in addition to the related GAAP measures provide investors greater transparency to the information used by management in its financial decision-making.
Reconciliation of Revenues to Adjusted Gross Profit | |||||||||||
(Unaudited, in thousands) | |||||||||||
For the Three Months Ended | |||||||||||
2023 | 2022 | ||||||||||
Revenues | $ | 16,748 | 100.0 | % | $ | 20,605 | 100.0 | % | |||
Costs of processing and distribution | 6,074 | 36.3 | % | 6,410 | 31.1 | % | |||||
Gross profit, as reported | 10,674 | 63.7 | % | 14,195 | 68.9 | % | |||||
Inventory write-off | 730 | 4.4 | % | — | — | % | |||||
Inventory purchase price adjustment | 235 | 1.4 | % | 410 | 2.0 | % | |||||
Non-GAAP gross profit, adjusted | $ | 11,639 | 69.5 | % | $ | 14,605 | 70.9 | % |
Non-GAAP Operating Expenses, Adjusted | |||||||
(Unaudited, in thousands) | |||||||
For the Three Months Ended | |||||||
2023 | 2022 | ||||||
Operating Expenses | $ | 24,448 | $ | 23,116 | |||
Non-cash stock-based compensation | 985 | 1,374 | |||||
Gain on acquisition contingency | (1,066 | ) | (8,503 | ) | |||
Asset impairment and abandonments | 553 | 939 | |||||
Transaction and integration expenses | 463 | 916 | |||||
Severance and restructuring costs | 466 | — | |||||
Non-GAAP Operating Expenses, adjusted* | $ | 23,047 | $ | 28,390 | |||
Non-GAAP Operating Expenses, adjusted, as a percent of revenues | 137.6 | % | 137.8 | % | |||
*Please note this reconciliation does not include HOLO™ Portal capitalized costs of | |||||||
#See explanations in Non-GAAP Financial Measures above. |
Reconciliation of Net Income Applicable to Common Shares and Income Per Diluted Share to Adjusted Net Loss Applicable to Common Shares and Adjusted Net Loss Per Diluted Share | ||||||||||||||||
(Unaudited, in thousands except per share data) | ||||||||||||||||
For the Three Months Ended | ||||||||||||||||
Net Income Applicable to Common Shares | Amount Per Diluted Share | Net Income Applicable to Common Shares | Amount Per Diluted Share | |||||||||||||
Net income from continuing operations | $ | 4,145 | $ | 0.31 | $ | 27 | $ | 0.00 | ||||||||
Change in fair value of warrant liability | (5,288 | ) | (0.40 | ) | (9,743 | ) | (1.65 | ) | ||||||||
Gain on acquisition contingency | (1,066 | ) | (0.08 | ) | (8,503 | ) | (1.44 | ) | ||||||||
Non-cash stock-based compensation | 985 | 0.07 | 1,374 | 0.23 | ||||||||||||
Foreign exchange (gain) loss | (238 | ) | (0.02 | ) | 353 | 0.06 | ||||||||||
Gain on sale of Coflex | (12,631 | ) | (0.95 | ) | — | 0.00 | ||||||||||
Asset impairment and abandonments | 553 | 0.04 | 939 | 0.16 | ||||||||||||
Transaction and financing expenses | 463 | 0.03 | 916 | 0.15 | ||||||||||||
Inventory purchase price adjustment | 235 | 0.02 | 410 | 0.07 | ||||||||||||
Product rationalization | 730 | 0.05 | — | 0.00 | ||||||||||||
Severance and restructuring costs | 466 | 0.03 | — | 0.00 | ||||||||||||
Tax effect on adjustments | 17 | 0.00 | — | 0.00 | ||||||||||||
Non-GAAP net loss from continuing operations, adjusted* | $ | (11,629 | ) | $ | (0.90 | ) | $ | (14,227 | ) | $ | (2.42 | ) | ||||
*Please note this reconciliation does not include HOLO™ Portal capitalized costs of | ||||||||||||||||
#See explanations in Non-GAAP Financial Measures above. |
Reconciliation of Net Income Applicable to Commons Shares to Adjusted EBITDA | ||||||||
(Unaudited, in thousands) | ||||||||
For the Three Months Ended | ||||||||
2023 | 2022 | |||||||
Net income from continuing operations | $ | 4,145 | $ | 27 | ||||
Interest expense, net | 252 | 252 | ||||||
Income tax provision | 133 | 162 | ||||||
Depreciation | 450 | 509 | ||||||
EBITDA | $ | 4,980 | $ | 950 | ||||
Reconciling items impacting EBITDA | ||||||||
Non-cash stock-based compensation | 985 | 1,374 | ||||||
Foreign exchange loss | (238 | ) | 353 | |||||
Other reconciling items* | ||||||||
Inventory purchase price adjustment | 235 | 410 | ||||||
Change in fair value of warrant liability | (5,288 | ) | (9,743 | ) | ||||
Gain on acquisition contingency | (1,066 | ) | (8,503 | ) | ||||
Gain on sale of Coflex | (12,631 | ) | — | |||||
Asset impairment and abandonments | 553 | 939 | ||||||
Transaction and financing expenses | 463 | 916 | ||||||
Product rationalization | 730 | — | ||||||
Severance and restructuring costs | 466 | — | ||||||
Adjusted EBITDA* | $ | (10,811 | ) | $ | (13,304 | ) | ||
Adjusted EBITDA as a percent of revenues | (64.6 | )% | (64.6 | )% | ||||
*Please note this reconciliation does not include HOLO™ Portal capitalized costs of | ||||||||
#See explanations in Non-GAAP Financial Measures above. |
Source:
2023 GlobeNewswire, Inc., source