NuVasive Announces Second Quarter 2022 Financial Results

2022-08-08 14:10:59 By : Ms. May Xie

888-776-0942 from 8 AM - 10 PM ET

–Strong year-over-year net sales growth, driven by new product introductions–

–Company reiterates full-year guidance range for reported year-over-year net sales growth of 6%–8%–

–Company updates full-year guidance range for GAAP diluted EPS; maintains prior non-GAAP diluted EPS range provided May 4, 2022 –

SAN DIEGO , Aug. 3, 2022 /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 ended June 30, 2022 .

"We are encouraged by our top-line growth in the second quarter, driven by procedure volumes, new product introductions, and continued global execution of our growth strategies," said Chris Barry , chief executive officer of NuVasive. "As surgeons look for differentiated technologies to enable more intelligent surgery, our C360 portfolio, X360 portfolio and Pulse platform will continue to support our innovation strategy. While we are experiencing the macro environmental pressures that face many companies, we remain focused on our commitment to deliver value to all stakeholders—most importantly, to change the lives of more patients around the world."

Second Quarter 2022 Results NuVasive reported total net sales of $310.5 million , a 5.3% increase as reported and a 7.8% increase on a constant currency basis, compared to $294.8 million in the prior year period. Second quarter 2022 total net sales were driven by the 2021 commercial launches of the Simplify Cervical Disc and the Pulse platform, as well as higher procedure volume in the U.S. and strong international performance.

For the second quarter of 2022, GAAP gross profit was $224.7 million , compared to $216.5 million in the prior year period. GAAP gross margin was 72.4%, compared to 73.4% in the prior year period. On a non-GAAP basis, gross profit was $224.7 million , compared to $217.1 million in the prior year period. Non-GAAP gross margin was 72.4%, compared to 73.6% in the prior year period.

The Company reported GAAP net loss of ($0.9) million , or diluted loss per share of ($0.02) , compared to GAAP net income of $1.8 million , or diluted earnings per share of $0.03 in the prior year period. On a non-GAAP basis, the Company reported net income of $24.8 million , or diluted earnings per share of $0.47 , compared to non-GAAP net income of $31.2 million , or diluted earnings per share of $0.60 in the prior year period.

Cash and cash equivalents were $226.0 million as of June 30, 2022 .

Full-year 2022 Financial Guidance Based on the Company's strong performance for the six months ended June 30, 2022 , the Company reiterated its full-year guidance range for reported net sales growth. Based on updated expectations for foreign currency exchange rates, the Company revised its guidance range for constant currency net sales growth, as well as for GAAP operating margin, as shown in the table below. In addition, the Company updated its full-year guidance range for GAAP diluted EPS and maintained its prior non-GAAP diluted EPS range provided on May 4, 2022 .

Net sales growth (constant currency)*

* Reflects expectations for net sales growth in 2022 compared to 2021. Net sales growth on a constant currency basis excludes year-over-year currency fluctuations, which the Company currently expects to create a negative impact of approximately 270 basis points in 2022.

** Prior guidance reflects ranges provided on May 4, 2022. Current guidance reflects ranges provided on August 3, 2022.

*** Reflects updated expectations for the impact on diluted EPS of applying the if-converted method to the Company's convertible notes. Additionally, includes the impact of net unrealized foreign currency exchange gains or losses incurred as of June 30, 2022, and does not assume future net unrealized gains or losses related to foreign currency exchange rates.

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this press release and in the Investor Relations section of our website.

Conference Call and Webcast NuVasive will hold a conference call on Wednesday, August 3, 2022, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the second quarter 2022. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call and supplemental financial information of our second quarter 2022 results will be available on the Investor Relations page of our website at www.nuvasive.com. An audio replay of the call will be available until August 10, 2022. 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: 13731013. In addition, the webcast will be archived on NuVasive's website. 

About NuVasive NuVasive, 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 operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.

Reconciliation of GAAP to Non-GAAP Information Management uses certain non-GAAP financial measures such as non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating expenses, non-GAAP operating margin, non-GAAP net income (loss), and non-GAAP diluted earnings (loss) per share. These non-GAAP financial measures exclude amortization of intangible assets, business transition costs, purchased in-process research and development, one-time restructuring charges, non-cash purchase accounting adjustments, inventory charges associated with product withdrawals, certain foreign currency impacts and related items in connection with acquisitions, investments and divestitures, 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, non-cash interest expense (excluding debt issuance cost) and other significant one-time items. 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 charges, non-cash purchase accounting adjustments, inventory charges associated with product withdrawals, certain foreign currency impacts and related items in connection with acquisitions, investments and divestitures, 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 in the financial tables accompanying this press release are reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measure.

Forward-Looking Statements NuVasive 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. In addition, this news release contains selected financial results from the second quarter 2022, as well as projections for 2022 financial guidance and expectations regarding longer-term financial performance. The Company's results for the second quarter of 2022 are prior to the completion of review and audit procedures by the Company's external auditors and are subject to adjustment. In addition, the Company's projections for 2022 financial guidance and expectations regarding longer-term financial performance represent initial estimates, and are subject to the risk of being inaccurate because of the preliminary nature of the forecasts, the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability. 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; 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, and the other risks and uncertainties more fully 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.

(in thousands, except per share data)

Cost of sales (excluding below amortization of intangible assets):

Interest and other expense, net:

Total interest and other expense, net

(Loss) income before income taxes

Net (loss) income per share:

(in thousands, except par value data) 

Accounts receivable, net of allowances of $19,166 and $21,064, respectively

Prepaid expenses and other current assets

Accounts payable and accrued liabilities

Accrued payroll and related expenses

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

Common stock, $0.001 par value; 150,000 shares authorized at June 30, 2022 and December 31, 2021; 58,863 shares issued and 52,061 outstanding at June 30, 2022; 58,469 shares issued and 51,769 outstanding at December 31, 2021

Treasury stock at cost; 6,802 shares and 6,700 shares at June 30, 2022 and December 31, 2021, respectively

Consolidated Statements of Cash Flows 

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

Changes in fair value of contingent consideration

Net loss (gain) on strategic investments

Net loss from foreign currency adjustments

Changes in operating assets and liabilities, net of effects from acquisitions:

Prepaid expenses and other current assets

Accounts payable and accrued liabilities

Accrued payroll and related expenses

Net cash provided by operating activities

Acquisition of Simplify Medical, net of cash acquired

Payment of contingent consideration for Simplify Medical

Purchases of property and equipment

Proceeds from sales of marketable securities

Proceeds from maturities of marketable securities

Net cash used in investing activities

Proceeds from the issuance of common stock

Payments upon settlement of senior convertible notes

Net cash used in financing activities

Effect of exchange rate changes on cash

Decrease in cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash at beginning of period

Cash, cash equivalents and restricted cash at end of period

For the Three Months Ended June 30, 2022

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Net (Loss) to Adjusted EBITDA

Litigation related expenses and settlements1

Net loss on strategic investments

Non-cash acquisition-related foreign currency impacts4

Represents expenses and settlements associated with certain ongoing litigation matters, 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, third 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, asset write-offs and product remanufacturing to comply with European medical device regulation.

Represents non-cash adjustments to acquisition-related intercompany balances and contingent consideration liabilities held in a foreign currency.

Represents the impact from tax affecting the adjustments above at their statutory tax rate.

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

For the Six Months Ended June 30, 2022

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Net Income to Adjusted EBITDA

Non-cash purchase accounting adjustments on acquisitions1

Litigation related expenses and settlements2

Net loss on strategic investments

Non-cash acquisition-related foreign currency impacts5

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Represents expenses and settlements associated with certain ongoing litigation matters, 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, third 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, asset write-offs and product remanufacturing to comply with European medical device regulation.

Represents non-cash adjustments to acquisition-related intercompany balances and contingent consideration liabilities held in a foreign currency.

Represents the impact from tax affecting the adjustments above at their statutory tax rate.

Reported GAAP diluted EPS is calculated using Net Income plus interest and debt issuance costs on senior convertible notes whose effect is dilutive, net of tax divided by diluted WASO. 

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

For the Three Months Ended June 30, 2021

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Net Income to Adjusted EBITDA

Non-cash purchase accounting adjustments on acquisitions1

Litigation related expenses and settlements2

Net gain on strategic investments

Non-cash acquisition-related foreign currency impacts5

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Represents expenses associated with certain ongoing litigation matters, 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, third 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, asset write-offs and product remanufacturing to comply with European medical device regulation.

Represents non-cash adjustments to acquisition-related intercompany balances and contingent consideration liabilities held in a foreign currency.

Represents the impact from tax affecting the adjustments above at their statutory tax rate.

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

For the Six Months Ended June 30, 2021

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited - in thousands, except per share data)

Net (Loss) to Adjusted EBITDA

Non-cash purchase accounting adjustments on acquisitions1

Litigation related expenses and settlements2

Net gain on strategic investments

Non-cash acquisition-related foreign currency impacts5

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Represents expenses associated with certain ongoing litigation matters, 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, third 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, asset write-offs and product remanufacturing to comply with European medical device regulation.

Represents non-cash adjustments to acquisition-related intercompany balances and contingent consideration liabilities held in a foreign currency.

Represents the impact from tax affecting the adjustments above at their statutory tax rate.

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

Reconciliation of GAAP to Non-GAAP EPS

GAAP diluted earnings (loss) per share

Inventory charges associated with product withdrawal5

Non-GAAP diluted earnings per share

Data has been intentionally rounded and may not sum.

Prior guidance reflects the range provided May 4, 2022. Current guidance reflects the range provided August 3, 2022.

GAAP diluted EPS includes the dilutive impact of applying the if-converted method to the Company's convertible notes. Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible notes for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

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

Represents charges for inventory write-offs associated with the Company's product withdrawals. During the third quarter of 2021, the Company made a determination to withdraw certain products marketed and sold by its wholly-owned subsidiary, NuVasive Specialized Orthopedics.

Includes costs primarily associated with litigation related expenses and settlements, non-cash acquisition-related foreign currency impacts, non-cash purchase accounting adjustments on acquisitions, net gain on strategic investments and business transition costs. See Reconciliation of GAAP to Non-GAAP Financial Measures tables within respective earnings releases for further detail.

Represents the impact from tax affecting the adjustments above at their statutory tax rate.

Reconciliation of GAAP to Non-GAAP Operating Margin %

Inventory charges associated with product withdrawal4

Data has been intentionally rounded and may not sum.

Prior guidance reflects the range provided May 4, 2022. Current guidance reflects the range provided August 3, 2022.

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

Represents charges for inventory write-offs associated with the Company's product withdrawals. During the third quarter of 2021, the Company made a determination to withdraw certain products marketed and sold by its wholly-owned subsidiary, NuVasive Specialized Orthopedics.

Includes costs primarily associated with litigation related expenses and settlements, non-cash purchase accounting adjustments on acquisitions, and business transition costs. See Reconciliation of GAAP to Non-GAAP Financial Measures tables within respective earnings releases for further detail.

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