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8-K - 8-K - NUVASIVE INCnuva-8k_20210728.htm

Exhibit 99.1

 

NEWS RELEASE

 

NuVasive Announces Second Quarter 2021 Financial Results

 

-- Net sales increase driven by recovery across all procedural segments and continued strong international growth --

-- Pulse platform clinical evaluations underway in Europe following latest CE certification --

-- Company provides full-year 2021 financial guidance --

 

SAN DIEGO July 28, 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 ended June 30, 2021.

 

Second Quarter 2021 Highlights

 

Net sales increased 44.8% to $294.8 million, or 43.3% on a constant currency basis;

 

GAAP operating margin of 3.6%; Non-GAAP operating margin of 13.9%; and

 

GAAP diluted earnings per share of $0.03; Non-GAAP diluted earnings per share of $0.60.

 

“NuVasive continued to see the spine market stabilize throughout the second quarter, providing us the opportunity to help more surgeons and patients around the globe. Our continued investments in the cervical and anterior procedural segments and our international commercial organization are advancing both our near- and long-term growth strategy,” said J. Christopher Barry, chief executive officer of NuVasive. “Following our latest CE certification, the Pulse platform clinical evaluations and surgeon feedback have exceeded our expectations. The ability for multiple technologies to be utilized in a single, integrated platform enables surgeons to increase surgical reproducibility—a pivotal step in how NuVasive is transforming spine surgery.”

 

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

 

Second Quarter 2021 Results

NuVasive reported second quarter 2021 total net sales of $294.8 million, a 44.8% increase compared to $203.6 million for the second quarter 2020. On a constant currency basis, second quarter 2021 total net sales increased 43.3% compared to the same period last year. The net sales results were due to recovery from the COVID-19 pandemic across all procedural segments and continued strong international growth.

 

For the second quarter 2021, GAAP gross profit was $216.5 million or $217.1 million on a non-GAAP basis, compared to GAAP and non-GAAP gross profit of $123.1 million in the prior year period. GAAP gross margin was 73.4% or 73.6% on a non-GAAP basis, compared to GAAP and non-GAAP gross margin of 60.5% in the prior year period. GAAP and non-GAAP gross profit improvement was primarily driven by incremental inventory reserves taken in the second quarter of 2020 resulting from pandemic-related impacts.

 

For the second quarter 2021, GAAP net income was $1.8 million or diluted earnings per share of $0.03, compared to GAAP net loss of $50.0 million or diluted loss per share of $0.98 in the prior year period. Non-GAAP net income was $31.2 million or diluted earnings per share of $0.60, compared to non-GAAP net loss of $20.4 million or diluted loss per share of $0.40 in the prior year period.

 


 

Cash, cash equivalents, and investments were $204.1 million as of June 30, 2021. In April 2021, the Simplify® Cervical Disc received approval from the U.S. Food and Drug Administration for two-level cervical total disc replacement, resulting in the payment of $45.8 million for the achievement of this regulatory milestone.

 

2021 Financial Guidance

Today, NuVasive announced full-year 2021 financial guidance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures. For full-year 2021, the Company expects:

 

Net sales in the range of $1.19 billion to $1.21 billion;

 

Non-GAAP operating margin in the range of 14.4% to 14.9%; and

 

Non-GAAP diluted earnings per share in the range of $2.25 to $2.35.

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 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, non-cash purchase accounting adjustments, 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, non-cash purchase accounting adjustments, 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 are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

 

 

 


 

 

 

 

For the Three Months Ended June 30, 2021

 

 

 

 

Reconciliation of GAAP to Non-GAAP Financial Measures

 

 

 

 

(Unaudited - in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

Operating Profit

 

Net Income

 

Diluted EPS

 

Diluted WASO7

 

Net Income to Adjusted EBITDA

 

 

 

 

Reported GAAP

$

216,548

 

$

10,746

 

$

1,799

 

$

0.03

 

 

52,211

 

$

1,799

 

 

 

 

% of net sales

 

73.4

%

 

3.6

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-cash purchase accounting adjustments on acquisitions1

 

556

 

 

556

 

 

556

 

 

 

 

 

 

 

 

556

 

 

 

 

Amortization of intangible assets

 

 

 

 

15,088

 

 

15,088

 

 

 

 

 

 

 

 

 

 

 

 

 

Litigation related expenses and settlements2

 

 

 

 

1,287

 

 

1,287

 

 

 

 

 

 

 

 

1,287

 

 

 

 

Business transition costs3

 

 

 

 

11,553

 

 

11,553

 

 

 

 

 

 

 

 

11,553

 

 

 

 

European medical device regulation4

 

 

 

 

1,689

 

 

1,689

 

 

 

 

 

 

 

 

1,689

 

 

 

 

Net gain on strategic investments

 

 

 

 

 

 

 

(2,101

)

 

 

 

 

 

 

 

(2,101

)

 

 

 

Non-cash acquisition-related foreign currency impacts5

 

 

 

 

 

 

 

3,545

 

 

 

 

 

 

 

 

3,545

 

 

 

 

Tax effect of adjustments6

 

 

 

 

 

 

 

(2,243

)

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense/(income), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,379

 

 

 

 

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,837

 

 

 

 

Depreciation and amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

37,522

 

 

 

 

Non-cash stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,298

 

 

 

 

Adjusted Non-GAAP

$

217,104

 

$

40,919

 

$

31,173

 

$

0.60

 

 

52,211

 

$

71,364

 

 

 

 

% of net sales

 

73.6

%

 

13.9

%

 

 

 

 

 

 

 

 

 

 

24.2

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

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.

 

 

2

 

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

 

 

3

 

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.

 

 

4

 

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

 

 

5

 

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

 

 

6

 

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

 

 

7

 

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)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

Operating Profit

 

Net (Loss) Income

 

Diluted EPS

 

Diluted WASO7

 

Net (Loss) to Adjusted EBITDA

 

 

 

 

Reported GAAP

$

415,986

 

$

23,085

 

$

(5,711

)

$

(0.11

)

 

51,473

 

$

(5,711

)

 

 

 

% of net sales

 

73.5

%

 

4.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-cash purchase accounting adjustments on acquisitions1

 

742

 

 

742

 

 

742

 

 

 

 

 

 

 

 

742

 

 

 

 

Amortization of intangible assets

 

 

 

 

28,425

 

 

28,425

 

 

 

 

 

 

 

 

 

 

 

 

 

Litigation related expenses and settlements2

 

 

 

 

3,248

 

 

3,248

 

 

 

 

 

 

 

 

3,248

 

 

 

 

Business transition costs3

 

 

 

 

17,137

 

 

17,137

 

 

 

 

 

 

 

 

17,137

 

 

 

 

European medical device regulation4

 

 

 

 

3,564

 

 

3,564

 

 

 

 

 

 

 

 

3,564

 

 

 

 

Net gain on strategic investments

 

 

 

 

 

 

 

(2,101

)

 

 

 

 

 

 

 

(2,101

)

 

 

 

Non-cash acquisition-related foreign currency impacts5

 

 

 

 

 

 

 

13,393

 

 

 

 

 

 

 

 

13,393

 

 

 

 

Tax effect of adjustments6

 

 

 

 

 

 

 

(8,494

)

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense/(income), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12,322

 

 

 

 

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,217

 

 

 

 

Depreciation and amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

73,954

 

 

 

 

Non-cash stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13,007

 

 

 

 

Adjusted Non-GAAP

$

416,728

 

$

76,201

 

$

50,203

 

$

0.96

 

 

52,140

 

$

134,772

 

 

 

 

% of net sales

 

73.6

%

 

13.5

%

 

 

 

 

 

 

 

 

 

 

23.8

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

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.

 

 

2

 

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

 

 

3

 

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.

 

 

4

 

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

 

 

5

 

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

 

 

6

 

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

 

 

7

 

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, 2020

 

 

 

 

Reconciliation of GAAP to Non-GAAP Financial Measures

 

 

 

 

(Unaudited - in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

Operating (Loss)

 

Net (Loss)

 

Diluted EPS

 

Diluted WASO7

 

Net (Loss) to Adjusted EBITDA

 

 

 

 

Reported GAAP

$

123,107

 

$

(37,303

)

$

(50,015

)

$

(0.98

)

 

51,224

 

$

(50,015

)

 

 

 

% of net sales

 

60.5

%

 

(18.3

%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangible assets

 

 

 

 

12,675

 

 

12,675

 

 

 

 

 

 

 

 

 

 

 

 

 

Litigation related expenses and settlements1

 

 

 

 

1,187

 

 

1,187

 

 

 

 

 

 

 

 

1,187

 

 

 

 

Business transition costs2

 

 

 

 

874

 

 

874

 

 

 

 

 

 

 

 

874

 

 

 

 

Purchase of in-process research and development3

 

 

 

 

1,011

 

 

1,011

 

 

 

 

 

 

 

 

1,011

 

 

 

 

European medical device regulation4

 

 

 

 

1,683

 

 

1,683

 

 

 

 

 

 

 

 

1,683

 

 

 

 

Non-cash interest expense on convertible notes

 

 

 

 

 

 

 

9,615

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss recognized on change in fair value of derivatives5

 

 

 

 

 

 

 

12,301

 

 

 

 

 

 

 

 

12,301

 

 

 

 

Tax effect of adjustments6

 

 

 

 

 

 

 

(9,697

)

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense/(income), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

16,220

 

 

 

 

Income tax benefit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,170

)

 

 

 

Depreciation and amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

35,166

 

 

 

 

Non-cash stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,037

 

 

 

 

Adjusted Non-GAAP

$

123,107

 

$

(19,873

)

$

(20,366

)

$

(0.40

)

 

51,224

 

$

8,294

 

 

 

 

% of net sales

 

60.5

%

 

(9.8

%)

 

 

 

 

 

 

 

 

 

 

4.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

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

 

 

2

 

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.

 

 

3

 

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

 

 

4

 

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

 

 

5

 

Represents the net change in fair value of the Company’s derivative asset and liability associated with the 2023 Notes.

 

 

6

 

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

 

 

7

 

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, 2020

 

 

 

 

Reconciliation of GAAP to Non-GAAP Financial Measures

 

 

 

 

(Unaudited - in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross Profit

 

Operating (Loss) Profit

 

Net (Loss) Income

 

Diluted EPS

 

Diluted WASO7

 

Net (Loss) to Adjusted EBITDA

 

 

 

 

Reported GAAP

$

311,123

 

$

(8,984

)

$

(44,717

)

$

(0.87

)

 

51,531

 

$

(44,717

)

 

 

 

% of net sales

 

67.1

%

 

(1.9

%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangible assets

 

 

 

 

25,324

 

 

25,324

 

 

 

 

 

 

 

 

 

 

 

 

 

Litigation related expenses and settlements1

 

 

 

 

4,290

 

 

4,290

 

 

 

 

 

 

 

 

4,290

 

 

 

 

Business transition costs2

 

 

 

 

(566

)

 

(566

)

 

 

 

 

 

 

 

(566

)

 

 

 

Purchase of in-process research and development3

 

 

 

 

1,011

 

 

1,011

 

 

 

 

 

 

 

 

1,011

 

 

 

 

European medical device regulation4

 

 

 

 

2,930

 

 

2,930

 

 

 

 

 

 

 

 

2,930

 

 

 

 

Non-cash interest expense on convertible notes

 

 

 

 

 

 

 

15,339

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss on strategic investments

 

 

 

 

 

 

 

1,411

 

 

 

 

 

 

 

 

1,411

 

 

 

 

Net loss recognized on change in fair value of derivatives5

 

 

 

 

 

 

 

12,301

 

 

 

 

 

 

 

 

12,301

 

 

 

 

Tax effect of adjustments6

 

 

 

 

 

 

 

(12,259

)

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense/(income), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

27,006

 

 

 

 

Income tax benefit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,343

)

 

 

 

Depreciation and amortization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

70,138

 

 

 

 

Non-cash stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,179

 

 

 

 

Adjusted Non-GAAP

$

311,123

 

$

24,005

 

$

5,064

 

$

0.10

 

 

52,148

 

$

65,640

 

 

 

 

% of net sales

 

67.1

%

 

5.2

%

 

 

 

 

 

 

 

 

 

 

14.2

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

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

 

 

2

 

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.

 

 

3

 

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

 

 

4

 

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

 

 

5

 

Represents the net change in fair value of the Company’s derivative asset and liability associated with the 2023 Notes.

 

 

6

 

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

 

 

7

 

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.

 


 

 


 

 

Full-Year 2021 Financial Guidance

 

Reconciliation of GAAP to Non-GAAP EPS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2020 Actuals1

 

 

2021 Guidance Range1, 2

 

 

 

 

GAAP diluted earnings (loss) per share

$0.72

 

 

$0.54 - 0.64

 

 

 

 

Impact of change to diluted share count3

 

0.01

 

 

0.00 - 0.05

 

 

 

 

Amortization of intangible assets

 

0.99

 

 

1.09 - 1.14

 

 

 

 

Non-cash interest expense on convertible notes4

 

0.79

 

 

 

 

 

 

 

European medical device regulation5

 

0.15

 

 

0.17 - 0.22

 

 

 

 

Other6

 

0.60

 

 

0.72 - 0.77

 

 

 

 

Tax effect of adjustments7

 

(0.59

)

 

(0.33) - (0.38)

 

 

 

 

Non-GAAP diluted earnings per share

$1.23

 

 

$2.25- 2.35

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

Data has been intentionally rounded and may not sum.

 

 

2

 

Guidance reflects the range provided July 28, 2021.

 

 

3

 

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.

 

 

4

 

Discontinuation of debt discount accretion for our Senior Convertible Notes resulting from adopting ASU 2020-06 on January 1, 2021.

 

 

5

 

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

 

 

6

 

Include costs primarily associated with litigation related expenses and settlements, non-cash acquisition-related foreign currency impacts, net loss recognized on change in fair value of derivatives and business transition costs. See Reconciliation of GAAP to Non-GAAP Financial Measures tables within respective earnings releases for further detail.

 

 

7

 

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

 

 

Full-Year 2021 Financial Guidance

Reconciliation of GAAP to non-GAAP Operating Margin %

 

 

 

 

 

 

 

 

 

 

2020 Actuals1

 

 

 

2021 Guidance Range1, 2

 

GAAP Operating Margin %

3.7%

 

 

 

6.5% - 7.0%

 

Amortization of intangible assets

4.9%

 

 

 

4.7% - 4.9%

 

European medical device regulation3

0.7%

 

 

 

0.7% - 0.9%

 

Other 4

1.8%

 

 

 

2.2% - 2.4%

 

Non-GAAP Operating Margin %

11.1%

 

 

 

14.4% - 14.9%

 

 

 

 

 

 

 

 

1

Data has been intentionally rounded and may not sum.

2

Guidance reflects the range provided July 28, 2021.

3

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

4

Include costs primarily associated with litigation related expenses and settlements, purchase of in-process research and development, and business transition costs. See Reconciliation of GAAP to Non-GAAP Financial Measures tables within respective earnings releases for further detail.

 

 


 

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 second quarter 2021. 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 will be available online from the Investor Relations page of the Company's website at www.nuvasive.com. After the live event, the webcast will remain available on NuVasive's website for 30 days. In addition, an audio replay of the call will be available until August 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: 13720558.

 

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. In addition, this news release contains selected financial results from the second quarter 2021, as well as projections for 2021 financial guidance and longer-term financial performance goals. The Company’s results for the second quarter 2021 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 2021 financial guidance and longer-term financial performance goals 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.

 


 

 


 

NuVasive, Inc.

 

Consolidated Statements of Operations

 

(in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(unaudited)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Products

 

$

266,763

 

 

$

183,664

 

 

$

512,214

 

 

$

418,351

 

Services

 

 

28,065

 

 

 

19,948

 

 

 

53,863

 

 

 

45,142

 

Total net sales

 

 

294,828

 

 

 

203,612

 

 

 

566,077

 

 

 

463,493

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Products

 

 

58,584

 

 

 

64,373

 

 

 

111,886

 

 

 

116,018

 

Services

 

 

19,696

 

 

 

16,132

 

 

 

38,205

 

 

 

36,352

 

Total cost of sales

 

 

78,280

 

 

 

80,505

 

 

 

150,091

 

 

 

152,370

 

Gross profit

 

 

216,548

 

 

 

123,107

 

 

 

415,986

 

 

 

311,123

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

157,397

 

 

 

126,444

 

 

 

303,351

 

 

 

256,675

 

Research and development

 

 

21,764

 

 

 

19,406

 

 

 

43,988

 

 

 

37,663

 

Amortization of intangible assets

 

 

15,088

 

 

 

12,675

 

 

 

28,425

 

 

 

25,324

 

Purchase of in-process research and development

 

 

 

 

 

1,011

 

 

 

 

 

 

1,011

 

Business transition costs

 

 

11,553

 

 

 

874

 

 

 

17,137

 

 

 

(566

)

Total operating expenses

 

 

205,802

 

 

 

160,410

 

 

 

392,901

 

 

 

320,107

 

Interest and other expense, net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

9

 

 

 

304

 

 

 

96

 

 

 

1,035

 

Interest expense

 

 

(4,388

)

 

 

(16,524

)

 

 

(12,418

)

 

 

(28,041

)

Other income (expense), net

 

 

1,269

 

 

 

(11,662

)

 

 

(11,257

)

 

 

(19,070

)

Total interest and other expense, net

 

 

(3,110

)

 

 

(27,882

)

 

 

(23,579

)

 

 

(46,076

)

Income (loss) before income taxes

 

 

7,636

 

 

 

(65,185

)

 

 

(494

)

 

 

(55,060

)

Income tax (expense) benefit

 

 

(5,837

)

 

 

15,170

 

 

 

(5,217

)

 

 

10,343

 

Consolidated net income (loss)

 

$

1,799

 

 

$

(50,015

)

 

$

(5,711

)

 

$

(44,717

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.03

 

 

$

(0.98

)

 

$

(0.11

)

 

$

(0.87

)

Diluted

 

$

0.03

 

 

$

(0.98

)

 

$

(0.11

)

 

$

(0.87

)

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

51,567

 

 

 

51,224

 

 

 

51,473

 

 

 

51,531

 

Diluted

 

 

52,211

 

 

 

51,224

 

 

 

51,473

 

 

 

51,531

 

 

 

 


 

NuVasive, Inc.

 

Consolidated Balance Sheets

 

(in thousands, except par value data)

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 2021

 

 

December 31, 2020

 

ASSETS

 

(Unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

204,138

 

 

$

856,869

 

Short-term marketable securities

 

 

 

 

 

173,145

 

Accounts receivable, net of allowances of $20,881 and $20,631, respectively

 

 

216,915

 

 

 

207,071

 

Inventory, net

 

 

319,734

 

 

 

300,623

 

Prepaid income taxes

 

 

3,990

 

 

 

4,727

 

Prepaid expenses and other current assets

 

 

20,971

 

 

 

19,749

 

Total current assets

 

 

765,748

 

 

 

1,562,184

 

Property and equipment, net

 

 

295,779

 

 

 

286,369

 

Intangible assets, net

 

 

278,097

 

 

 

152,264

 

Goodwill

 

 

636,727

 

 

 

559,553

 

Operating lease right-of-use assets

 

 

105,983

 

 

 

102,270

 

Deferred tax assets

 

 

46,699

 

 

 

15,755

 

Restricted cash and investments

 

 

1,494

 

 

 

1,494

 

Other assets

 

 

15,946

 

 

 

13,193

 

Total assets

 

$

2,146,473

 

 

$

2,693,082

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

110,702

 

 

$

110,401

 

Contingent consideration liabilities

 

 

7,404

 

 

 

7,289

 

Accrued payroll and related expenses

 

 

64,902

 

 

 

63,421

 

Operating lease liabilities

 

 

9,404

 

 

 

7,875

 

Income tax liabilities

 

 

1,320

 

 

 

2,073

 

Senior convertible notes

 

 

 

 

 

645,303

 

Total current liabilities

 

 

193,732

 

 

 

836,362

 

Long-term senior convertible notes

 

 

881,381

 

 

 

766,226

 

Deferred tax liabilities

 

 

2,798

 

 

 

2,807

 

Operating lease liabilities

 

 

114,490

 

 

 

111,634

 

Contingent consideration liabilities

 

 

92,966

 

 

 

29,752

 

Other long-term liabilities

 

 

20,205

 

 

 

22,686

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Redeemable equity component of senior convertible notes

 

 

 

 

 

4,697

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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, 2021 and December 31, 2020; 58,332 shares issued and 51,665 outstanding at June 30, 2021; 57,945 shares issued and 51,376 outstanding at December 31, 2020

 

 

62

 

 

 

62

 

Additional paid-in capital

 

 

1,420,277

 

 

 

1,550,001

 

Accumulated other comprehensive loss

 

 

(7,622

)

 

 

(7,585

)

Retained earnings

 

 

104,083

 

 

 

45,322

 

Treasury stock at cost; 6,667 shares and 6,569 shares at June 30, 2021 and December 31, 2020, respectively

 

 

(675,899

)

 

 

(668,882

)

Total equity

 

 

840,901

 

 

 

918,918

 

Total liabilities and equity

 

$

2,146,473

 

 

$

2,693,082

 

 

 


 

NuVasive, Inc.

 

Consolidated Statements of Cash Flows

 

(in thousands)

 

 

 

Six Months Ended June 30,

 

(unaudited)

 

2021

 

 

2020

 

Operating activities:

 

 

 

 

 

 

 

 

Consolidated net loss

 

$

(5,711

)

 

$

(44,717

)

Adjustments to reconcile net loss to net cash provided by operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

73,954

 

 

 

70,138

 

Amortization of non-cash interest

 

 

4,721

 

 

 

18,573

 

Stock-based compensation

 

 

13,007

 

 

 

2,235

 

Reserves on current assets

 

 

8,716

 

 

 

33,148

 

Purchase of in-process research and development

 

 

 

 

 

1,011

 

Net (gain) loss on strategic investments

 

 

(2,101

)

 

 

1,411

 

Net loss on change in fair value of derivatives

 

 

 

 

 

12,301

 

Net loss from foreign currency adjustments

 

 

13,402

 

 

 

5,255

 

Other non-cash adjustments

 

 

13,206

 

 

 

2,431

 

Deferred income taxes

 

 

(2,942

)

 

 

(5,712

)

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

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(11,541

)

 

 

25,132

 

Inventory

 

 

(20,442

)

 

 

(32,997

)

Prepaid expenses and other current assets

 

 

(1,589

)

 

 

(2,727

)

Accounts payable and accrued liabilities

 

 

(5,244

)

 

 

1,319

 

Accrued payroll and related expenses

 

 

1,902

 

 

 

(44,388

)

Income taxes

 

 

58

 

 

 

(9,306

)

Net cash provided by operating activities

 

 

79,396

 

 

 

33,107

 

Investing activities:

 

 

 

 

 

 

 

 

Acquisition of Simplify Medical, net of cash acquired

 

 

(149,463

)

 

 

 

Payment of contingent consideration for Simplify Medical

 

 

(45,850

)

 

 

 

Acquisitions and investments

 

 

(500

)

 

 

 

Purchases of intangible assets

 

 

(1,200

)

 

 

(2,490

)

Purchases of property and equipment

 

 

(53,483

)

 

 

(52,065

)

Purchases of marketable securities

 

 

 

 

 

(130,096

)

Proceeds from sales of marketable securities

 

 

127,023

 

 

 

 

Proceeds from maturities of marketable securities

 

 

46,000

 

 

 

 

Other investing activities

 

 

180

 

 

 

 

Net cash used in investing activities

 

 

(77,293

)

 

 

(184,651

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from the issuance of common stock

 

 

3,803

 

 

 

3,871

 

Purchases of treasury stock

 

 

(6,964

)

 

 

(79,026

)

Payment of contingent consideration

 

 

(3

)

 

 

(7,053

)

Proceeds from issuance of convertible debt, net of issuance costs

 

 

 

 

 

874,404

 

Proceeds from sale of warrants

 

 

 

 

 

93,915

 

Purchases of convertible note hedges

 

 

 

 

 

(147,825

)

Payments upon settlement of senior convertible notes

 

 

(649,426

)

 

 

 

Other financing activities

 

 

(671

)

 

 

(2,307

)

Net cash (used in) provided by financing activities

 

 

(653,261

)

 

 

735,979

 

Effect of exchange rate changes on cash

 

 

(1,573

)

 

 

(696

)

(Decrease) increase in cash, cash equivalents and restricted cash

 

 

(652,731

)

 

 

583,739

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

858,363

 

 

 

214,528

 

Cash, cash equivalents and restricted cash at end of period

 

$

205,632

 

 

$

798,267

 

###

 

 


  Investor Contact:

Juliet C. Cunningham

NuVasive, Inc.

858-210-2129

investorrelations@nuvasive.com

 

Media Contact:

Amanda Rocha

NuVasive, Inc.

858-882-5062

media@nuvasive.com