— 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 – February 25, 2021 – 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 Results
NuVasive 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 Results
NuVasive 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 Medical
In a separate news release, NuVasive announced it has acquired Simplify Medical, a privately held company and developer of the Simplify® 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 Information
For 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 Information
Management 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.
Investor Conference Call
NuVasive 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 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 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 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. 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.
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Investor Contact:
[email protected]
Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
[email protected]