PR Newswire | Feb 25, 2021 04:03PM EST

02/25 15:03 CST

NuVasive Announces Fourth Quarter and Full Year 2020 Financial Results-- Acquires Simplify Medical and the most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment --- Submits 510(k) clearance for Pulse platform and reiterates summer 2021 launch --- Continued to increase R&D investments in 2020 to advance Company's innovation roadmap --- Delivered strong Q4 2020 international growth -- SAN DIEGO, Feb. 25, 2021

SAN DIEGO, Feb. 25, 2021 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced financial results for the quarter and full year ended Dec. 31, 2020.

Fourth Quarter 2020

* Net sales decreased 6.0% to $291.8 million, or 6.7% on a constant currency basis; * GAAP operating margin of 6.9%; Non-GAAP operating margin of 15.8%; and * GAAP diluted earnings per share of $0.03; Non-GAAP diluted earnings per share of $0.59.

Full Year 2020

* Net sales decreased 10.1% to $1.051 billion, or 10.2% on a constant currency basis; * GAAP operating margin of 3.7%; Non-GAAP operating margin of 11.1%; and * GAAP diluted loss per share of $0.72; Non-GAAP diluted earnings per share of $1.23.

"NuVasive continues to see significant impact from COVID-19 on elective surgical procedures and patient sentiment, particularly within the U.S. market, which increased late in the fourth quarter," said J. Christopher Barry, chief executive officer of NuVasive. "Against a challenging 2020, we made key investments in infrastructure, talent, and innovation to unlock our ability to fulfill our long-term strategy. We are excited about the acquisition of Simplify Medical to advance our C360 portfolio and the 510(k) submission for the Pulse platform. We remain committed to delivering enhanced value to shareholders, surgeons, and employees, while helping change the lives of patients around the globe."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

Fourth Quarter 2020 ResultsNuVasive reported fourth quarter 2020 total net sales of $291.8 million, a 6.0% decrease compared to $310.4 million for the fourth quarter 2019. On a constant currency basis, fourth quarter 2020 total net sales decreased 6.7% compared to the same period last year driven by the impact of COVID-19 on elective surgeries.

For the fourth quarter 2020, GAAP and non-GAAP gross profit was $207.2 million and $208.9 million, respectively, and GAAP and non-GAAP gross margin was 71.0% and 71.6%, respectively. These results compared to GAAP and non-GAAP gross profit of $227.1 million and GAAP and non-GAAP gross margin of 73.2%, for the fourth quarter 2019. The decline in GAAP and non-GAAP gross margin was primarily due to the decrease in net sales and incremental reserves for inventory.

The Company reported GAAP net income of $1.7 million, or diluted earnings per share of $0.03, for the fourth quarter 2020 compared to GAAP net income of $29.9 million, or diluted earnings per share of $0.55, for the fourth quarter 2019. On a non-GAAP basis, the Company reported net income of $30.4 million, or diluted earnings per share of $0.59, for the fourth quarter 2020 compared to non-GAAP net income of $38.5 million, or diluted earnings per share of $0.73, for the fourth quarter 2019.

Free cash flow for the quarter ended Dec. 31, 2020, was $44.8 million compared to $46.3 million in the prior year period.

Full Year 2020 ResultsNuVasive reported full year 2020 total net sales of $1.051 billion, a 10.1% decrease compared to $1.168 billion for the full year 2019. On a constant currency basis, full year 2020 total net sales decreased 10.2% compared to the full year 2019, which reflects the impact of the COVID-19 pandemic.

For the full year 2020, GAAP and non-GAAP gross profit was $729.0 million and $730.7 million, respectively, and GAAP and non-GAAP gross margin was 69.4% and 69.5%, respectively. These results compared to GAAP and non-GAAP gross profit of $855.7 million, and GAAP and non-GAAP gross margin of 73.3% for the full year 2019. The decrease in GAAP and non-GAAP gross margin was primarily a result of incremental reserves for inventory attributed to projected demand for certain spinal hardware products impacted by COVID-19.

The Company reported GAAP net loss of $37.2 million, or diluted loss per share of $0.72, for the full year 2020 compared to GAAP net income of $65.2 million, or diluted earnings per share of $1.23, for the full year 2019. On a non-GAAP basis, the Company reported net income of $63.8 million, or diluted earnings per share of $1.23, for the full year 2020 compared to non-GAAP net income of $129.8 million, or diluted earnings per share of $2.47, for the full year 2019. See the "Reconciliation of GAAP to Non-GAAP Financial Measures" table for a reconciliation of these GAAP and non-GAAP financial measures.

Cash, cash equivalents, and investments were $1.030 billion as of Dec. 31, 2020, compared to $213 million reported as of Dec. 31, 2019.

Simplify MedicalIn a separate news release, NuVasive announced it has acquired Simplify Medical, a privately held company and developer of the Simplify(r) Cervical Artificial Disc for cervical total disc replacement (cTDR), as of Feb. 24, 2021. The transaction provides NuVasive with the most clinically effective technology in the cTDR procedure segment and further distinguishes NuVasive's C360 cervical portfolio in the market.

Supplementary Financial InformationFor additional financial detail, please visit the Investor Relations section of the Company's website at www.nuvasive.com to access Supplementary Financial Information.

Reconciliation of GAAP to Non-GAAP InformationManagement uses certain non-GAAP financial measures such as non-GAAP diluted earnings (loss) per share, non-GAAP net income, non-GAAP operating expenses and non-GAAP operating margin, which exclude amortization of intangible assets, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses from strategic investments, gains and losses from changes in fair value of derivatives and non-cash interest expense (excluding debt issuance cost). Management also uses certain non-GAAP measures which are intended to exclude the impact of foreign exchange currency fluctuations. The measure constant currency utilizes an exchange rate that eliminates fluctuations when calculating financial performance numbers. The Company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital. Additionally, the Company uses an adjusted EBITDA measure which represents earnings before interest, taxes, depreciation and amortization and excludes the impact of stock-based compensation, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses on strategic investments, gains and losses from changes in fair value of derivatives and other significant one-time items.

Management calculates the non-GAAP financial measures provided in this earnings release excluding these costs and uses these non-GAAP financial measures to enable it to further and more consistently analyze the period-to-period financial performance of its core business operations. Management believes that providing investors with these non-GAAP measures gives them additional information to enable them to assess, in the same way management assesses, the Company's current and future continuing operations. These non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from non-GAAP measures used by other companies. Set forth below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

For the Three Months Ended December 31, 2020

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Gross Profit Operating Net Income Diluted Diluted Net Income to Profit EPS WASO^5 Adjusted EBITDA

Reported $ 207,179 $ 20,235 $ 1,692 $ 0.03 51,870 $ 1,692 GAAP

% of net 71.0% 6.9% sales

Amortization of 12,576 12,576 intangible assets

Litigation related expenses and 1,310 1,310 1,310 settlements^ 1

Business transition 8,337 8,337 8,337 costs^2

European medical 1,706 3,614 3,614 3,614 device regulation^3

Non-cash interest expense on 12,844 convertible notes

Net gain on strategic (10) (10) investments

Tax effect of (9,989) adjustments^ 4

Interest expense/ 21,136 (income), net

Income tax (628) benefit

Depreciation and 34,840 amortization

Non-cash stock-based 7,706 compensation

Adjusted $ 208,885 $ 46,072 $ 30,374 $ 0.59 51,870 $ 77,997 Non-GAAP

% of net 71.6% 15.8% 26.7% sales

^ Represents expenses associated with certain ongoing litigation matters,1 including infringement of the Company's intellectual property.

Costs related to acquisition, integration and business transition activities^ which include severance, relocation, consulting, leasehold exit costs, third2 party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

^ Represents costs specific to updating our quality system, product labeling,3 asset write-offs and product remanufacturing to comply with European medical device regulation.

^ Represents the impact from tax affecting the adjustments above at their4 statutory tax rate. The impact of these adjustments to the tax rate results in an annual tax rate of ~22% on a GAAP basis and ~24% on a non-GAAP basis.

^ Adjusted non-GAAP diluted WASO excludes the impact of all dilutive securities,5 including convertible notes for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

For the Year Ended December 31, 2020

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Gross Profit Operating Net (Loss) Income Diluted Diluted Net (Loss) to Profit EPS WASO^7 Adjusted EBITDA

Reported $ 728,951 $ 38,303 $ (37,153) $ (0.72) 51,416 $ (37,153) GAAP

% of net 69.4% 3.7% sales

Amortization of 51,726 51,726 intangible assets

Litigation related expenses and 6,996 6,996 6,996 settlements^ 1

Business transition 10,878 10,878 10,878 costs^2

Purchase of in-process research and 1,011 1,011 1,011 development^ 3

European medical 1,706 7,693 7,693 7,693 device regulation^4

Non-cash interest expense on 40,866 convertible notes

Net loss on strategic 268 268 investments

Net loss recognized on change in fair value 12,301 12,301 of derivatives^ 5

Tax effect of (30,823) adjustments^ 6

Interest expense/ 68,994 (income), net

Income tax (10,392) benefit

Depreciation and 140,937 amortization

Non-cash stock-based 17,457 compensation

Adjusted $ 730,657 $ 116,607 $ 63,763 $ 1.23 51,992 $ 218,990 Non-GAAP

% of net 69.5% 11.1% 20.8% sales

^ Represents expenses associated with certain ongoing litigation matters,1 including infringement of the Company's intellectual property.

Costs related to acquisition, integration and business transition activities^ which include severance, relocation, consulting, leasehold exit costs, third2 party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

^ Purchase of an in-process research and development asset which had no future3 alternative use.

^ Represents costs specific to updating our quality system, product labeling,4 asset write-offs and product remanufacturing to comply with European medical device regulation.

^ Represents the net change in fair value of the Company's derivative asset and5 liability associated with the 2023 Notes.

^ Represents the impact from tax affecting the adjustments above at their6 statutory tax rate. The impact of these adjustments to the tax rate results in an annual tax rate of ~22% on a GAAP basis and ~24% on a non-GAAP basis.

^ Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible7 notes for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

For the Three Months Ended December 31, 2019

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Gross Profit Operating Net Income Diluted Diluted Net Income to Profit EPS WASO^5 Adjusted EBITDA

Reported $ 227,098 $ 42,166 $ 29,876 $ 0.55 54,638 $ 29,876 GAAP

% of net 73.2% 13.6% sales

Amortization of 12,599 12,599 intangible assets

Litigation related expenses and 818 818 818 settlements^ 1

Business transition (7,141) (7,141) (7,141) costs^2

European medical 2,384 2,384 2,384 device regulation^3

Non-cash interest expense on 4,492 convertible notes

Tax effect of (4,513) adjustments^ 4

Interest expense/ 9,147 (income), net

Income tax 3,271 expense

Depreciation and 34,348 amortization

Non-cash stock-based 10,285 compensation

Adjusted $ 227,098 $ 50,826 $ 38,515 $ 0.73 52,979 $ 82,988 Non-GAAP

% of net 73.2% 16.4% 26.7% sales

^ Represents expenses associated with certain ongoing litigation matters,1 including infringement of the Company's intellectual property.

Costs related to acquisition, integration and business transition activities^ which include severance, relocation, consulting, leasehold exit costs, third2 party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

^ Represents costs specific to updating our quality system, product labeling,3 asset write-offs and product remanufacturing to comply with European medical device regulation.

^ Represents the impact from tax affecting the adjustments above at their4 statutory tax rate. The impact of these adjustments to the tax rate results in an annual tax rate of ~19% on a GAAP basis and ~21% on a non-GAAP basis.

^ Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible5 notes for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

For the Year Ended December 31, 2019

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Gross Profit Operating Net Income Diluted Diluted Net Income to Profit EPS WASO^5 Adjusted EBITDA

Reported $ 855,713 $ 123,050 $ 65,234 $ 1.23 53,160 $ 65,234 GAAP

% of net 73.3% 10.5% sales

Amortization of 51,097 51,097 intangible assets

Litigation related expenses and 7,794 7,794 7,794 settlements^ 1

Business transition (1,995) (1,995) (1,995) costs^2

European medical 5,069 5,069 5,069 device regulation^3

Non-cash interest expense on 17,617 convertible notes

Net loss on strategic 4,767 4,767 investments

Tax effect of (19,782) adjustments^ 4

Interest expense/ 36,608 (income), net

Income tax 15,283 expense

Depreciation and 135,593 amortization

Non-cash stock-based 30,732 compensation

Adjusted $ 855,713 $ 185,015 $ 129,801 $ 2.47 52,629 $ 299,085 Non-GAAP

% of net 73.3% 15.8% 25.6% sales

^ Represents expenses associated with certain ongoing litigation matters,1 including infringement of the Company's intellectual property.

Costs related to acquisition, integration and business transition activities^ which include severance, relocation, consulting, leasehold exit costs, third2 party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

^ Represents costs specific to updating our quality system, product labeling,3 asset write-offs and product remanufacturing to comply with European medical device regulation.

^ Represents the impact from tax affecting the adjustments above at their4 statutory tax rate. The impact of these adjustments to the tax rate results in an annual tax rate of ~19% on a GAAP basis and ~21% on a non-GAAP basis.

^ Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible5 notes for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

Investor Conference CallNuVasive will hold a conference call today at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the fourth quarter and full year ended Dec. 31, 2020, as well as its acquisition of Simplify Medical. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company's website at www.nuvasive.com. After the live webcast, the call will remain available on NuVasive's website through March 25, 2021. In addition, a telephone replay of the call will be available until March 4, 2021. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 21990639.

About NuVasiveNuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.

Forward-Looking StatementsNuVasive cautions you that statements included in this news release or made on the investor conference call referenced herein that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. Forward-looking statements include, but are not limited to, statements about the potential benefits of the acquisition of Simplify Medical, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. In addition, this news release contains selected financial results from the fourth quarter and full year 2020. The Company's results for the fourth quarter and full year 2020 are prior to the completion of review and audit procedures by the Company's external auditors and are subject to adjustment. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, the impact of the COVID-19 pandemic on the Company's business and financial results; the Company's ability to maintain operations to support its customers and patients in the near-term and to capitalize on future growth opportunities; the risk that Simplify Medical will not be integrated successfully and that benefits from the acquisition may not be fully realized or may take longer to realize than expected; risks associated with acceptance of the Company's surgical products and procedures by spine surgeons and hospitals, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products, the Company's ability to adequately manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel. Additional risks and uncertainties that may affect future results are described in the Company's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

NuVasive, Inc.

Consolidated Statements of Operations

(in thousands, except per share data)

Three Months Ended December 31, Year Ended December 31,

2020 2019 2020 2019

(Unaudited) (Unaudited)

Net sales:

Products $ 264,267 $ 279,234 $ 950,189 $ 1,044,569

Services 27,540 31,120 100,393 123,501

Total net 291,807 310,354 1,050,582 1,168,070sales

Cost of sales(excludingbelowamortizationof intangibleassets):

Products 65,742 63,211 247,809 232,474

Services 18,886 20,045 73,822 79,883

Total cost of 84,628 83,256 321,631 312,357sales

Gross profit 207,179 227,098 728,951 855,713

Operatingexpenses:

Selling,general and 144,260 160,365 547,195 611,181administrative

Research and 21,771 19,109 79,838 72,380development

Amortizationof intangible 12,576 12,599 51,726 51,097assets

Purchase ofin-process - - 1,011 -research anddevelopment

Businesstransition 8,337 (7,141) 10,878 (1,995)costs

Totaloperating 186,944 184,932 690,648 732,663expenses

Interest andother expense,net:

Interest 166 561 1,472 1,917income

Interest (21,302) (9,708) (70,466) (38,525)expense

Other income 1,965 128 (16,854) (5,925)(expense), net

Total interestand other (19,171) (9,019) (85,848) (42,533)expense, net

Income (loss)before income 1,064 33,147 (47,545) 80,517taxes

Income taxbenefit 628 (3,271) 10,392 (15,283)(expense)

Consolidatednet income $ 1,692 $ 29,876 $ (37,153) $ 65,234(loss)

Net income(loss) pershare:

Basic $ 0.03 $ 0.57 $ (0.72) $ 1.26

Diluted $ 0.03 $ 0.55 $ (0.72) $ 1.23

Weightedaverage sharesoutstanding:

Basic 51,343 52,117 51,416 51,956

Diluted 51,870 54,638 51,416 53,160

NuVasive, Inc.

Consolidated Balance Sheets

(in thousands, except par value data)

December 31,

2020 2019

ASSETS

Current assets:

Cash and cash equivalents $ 856,869 $ 213,034

Short-term marketable securities 173,145 -

Accounts receivable, net of allowances of 207,071 211,532$20,631and $17,019, respectively

Inventory, net 300,623 312,419

Prepaid income taxes 4,727 10,434

Prepaid expenses and other current assets 19,749 16,917

Total current assets 1,562,184 764,336

Property and equipment, net 286,369 266,318

Intangible assets, net 152,264 201,092

Goodwill 559,553 561,064

Operating lease right-of-use assets 102,270 66,932

Deferred tax assets 15,755 9,162

Restricted cash and investments 1,494 1,494

Other assets 13,193 14,892

Total assets $ 2,693,082 $ 1,885,290

LIABILITIES AND EQUITY

Current liabilities:

Accounts payable and accrued liabilities $ 110,401 $ 97,160

Contingent consideration liabilities 7,289 15,727

Accrued payroll and related expenses 63,421 86,458

Operating lease liabilities 7,875 5,567

Income tax liabilities 2,073 2,005

Senior convertible notes 645,303 -

Total current liabilities 836,362 206,917

Long-term senior convertible notes 766,226 623,298

Deferred tax liabilities 2,807 14,655

Operating lease liabilities 111,634 73,153

Other long-term liabilities 52,438 52,060

Commitments and contingencies

Redeemable equity component of senior 4,697 -convertible notes

Stockholders' equity:

Preferred stock, $0.001 par value; 5,000 shares - -authorized, none outstanding

Common stock, $0.001 par value; 150,000 and120,000 shares authorized at December 31, 2020and December 31, 2019, respectively; 57,945 62 62shares issued and 51,376 outstanding at December31, 2020; 57,525 issued and 52,145 outstandingat December 31, 2019

Additional paid-in capital 1,550,001 1,429,854

Accumulated other comprehensive loss (7,585) (9,418)

Retained earnings 45,322 82,475

Treasury stock at cost; 6,569 shares and 5,380shares at December 31, 2020 and December 31, (668,882) (587,766)2019, respectively

Total equity 918,918 915,207

Total liabilities and equity $ 2,693,082 $ 1,885,290

NuVasive, Inc.

Consolidated Statements of Cash Flows

(in thousands)

Year Ended December 31,

2020 2019

Operating activities:

Consolidated net (loss) income $ (37,153) $ 65,234

Adjustments to reconcile net (loss) income to netcash provided by operating activities:

Depreciation and amortization 140,937 135,593

Purchase of in-process research and development 1,011 -

Deferred income taxes (18,007) 5,844

Amortization of non-cash interest 48,986 21,288

Stock-based compensation 18,145 30,297

Net loss on strategic investments 268 4,767

Net loss recognized on change in fair value of 12,301 -derivatives

Reserves on current assets 53,902 18,382

Other non-cash adjustments 16,876 5,650

Changes in operating assets and liabilities, net ofeffects from acquisitions:

Accounts receivable 3,030 (16,407)

Inventory (40,765) (54,872)

Prepaid expenses and other current assets (4,986) (4,622)

Accounts payable and accrued liabilities 8,756 (3,924)

Accrued payroll and related expenses (23,654) 24,256

Income taxes 6,264 3,804

Net cash provided by operating activities 185,911 235,290

Investing activities:

Acquisitions and investments - (4,100)

Proceeds from other investments 1,143 -

Purchases of intangible assets (3,860) (7,501)

Purchases of property and equipment (105,729) (122,883)

Purchases of marketable securities (233,488) -

Proceeds from sales and maturities of marketable 60,000 -securities

Net cash used in investing activities (281,934) (134,484)

Financing activities:

Proceeds from the issuance of common stock 6,170 6,415

Payment of contingent consideration (7,053) (809)

Purchase of treasury stock (80,665) (14,478)

Proceeds from issuance of convertible debt, net of 873,848 -issuance costs

Proceeds from sale of warrants 93,915 -

Purchases of convertible note hedges (147,825) -

Other financing activities (1,734) 2,228

Net cash provided by (used in) financing activities 736,656 (6,644)

Effect of exchange rate changes on cash 3,202 131

Increase in cash, cash equivalents and restricted 643,835 94,293cash

Cash, cash equivalents and restricted cash at 214,528 120,235beginning of period

Cash, cash equivalents and restricted cash at end of $ 858,363 $ 214,528period

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SOURCE NuVasive, Inc.