Attached files

file filename
8-K - 8-K - NEVRO CORPnvro-8k_20201105.htm

Exhibit 99.1

 

Nevro Announces Third Quarter 2020 Financial Results

-Worldwide revenues increase 8%

- Nevro to submit PDN PMA Supplement to FDA in fourth quarter 2020

 

REDWOOD CITY, Calif., November 5, 2020 – Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced its financial results for the third quarter ended September 30, 2020.

 

Third Quarter 2020 Financial Overview

Worldwide revenue for the third quarter of 2020 was $108.5 million, an increase of 8% compared to $100.2 million in the prior year period. On a sequential basis, third quarter worldwide revenue increased 92% compared to the second quarter of 2020. U.S. revenue in the third quarter of 2020 was $90.9 million, an increase of 8% compared to $84.2 million in the prior year period. On a sequential basis, third quarter U.S. revenue increased 78% compared to the second quarter of 2020. In the third quarter of 2020, total U.S. permanent implants increased 9%, while trials were down 5% compared to the prior year period. U.S. revenue growth in the third quarter of 2020 was driven by an increase in patient and customer activity compared to the severely COVID-impacted second quarter of 2020. Daily patient trial activity increased 50% over the second quarter of 2020 and improved sequentially every month from July to October. The Company estimates a majority of the canceled permanent implant cases from the second quarter of 2020 were completed by the end of the third quarter of 2020. International revenue was $17.5 million, an increase of 10% on an as reported basis (5% on a constant currency basis), compared to $15.9 million in the prior year period. On a sequential basis, third quarter International revenue increased 226% compared to the second quarter of 2020 International revenue in the third quarter of 2020 was primarily driven by a successful Omnia launch, an increase in patient and customer activity, and a rebound in customer inventory levels compared to the second quarter of 2020.

 

We are pleased by the rebound in sales after a difficult second quarter and continue to be encouraged by the month-over-month improvement in trial procedures,” said D. Keith Grossman, Chairman, CEO and President of Nevro. With trials recovering, we believe our earlier expectations for roughly flat revenues compared to the prior year is still reasonable.  However, increases in COVID activity around the world and any further pressure on facility capacity and patient willingness to seek care could provide some downward pressure to that view.

 

Gross profit for the third quarter of 2020 was $76.1 million, an increase of 9% compared to $69.9 million in the prior year period. Gross margin was 70.1% in the third quarter compared to 69.8% in the prior year period. Compared to the prior year period, the increase in gross margin in the third quarter of 2020 was primarily attributable to product mix.

 

Operating expenses for the third quarter of 2020 were $79.6 million, a 7% decrease compared to $85.9 million in the prior year period.  The year-over-year decrease in operating expenses was primarily related to reduced

Page | 1

 


 

 

travel and training-related expenses, decreases in discretionary expenses during the COVID-19 pandemic, as well as continued management focus on driving leverage throughout the business which had begun well before COVID. This was partially offset by a one-time charge of $2.5 million in the quarter related to the Company’s CFO transition. Legal expenses associated with patent litigation were $2.3 million for the third quarter of 2020, compared to $1.9 million in the prior year period.

 

Net loss from operations for the third quarter of 2020 was $3.5 million, a 78% improvement compared to a loss of $16.0 million in the prior year period. Adjusted EBITDA for the third quarter of 2020 was $13.6 million, compared to a loss of $2.0 million in the prior year period.  Adjusted EBITDA excludes certain litigation expenses, interest, taxes and non-cash items such as stock-based compensation and depreciation and amortization. Please see the financial table below for GAAP to Non-GAAP reconciliations.

 

Cash, cash equivalents and short-term investments totaled $572.9 million as of September 30, 2020, an increase of $10.5 million in the third quarter of 2020.

 

PDN and NSRBP Clinical Update

Nevro’s Painful Diabetic Neuropathy (PDN) study continues to move forward and remains on track to present the next round of complete six-month data, along with a preview of 12-month responder rate data, at NANS in January of 2021. The Company has been in early discussions with the FDA regarding the submission strategy and is now planning to submit its PMA Supplement to the FDA in the fourth quarter of 2020. The Company remains on track for a second half 2021 commercial launch.  

 

The Company also expects to present its Non-Surgical Refractory Back Pain (NSRBP) study with three-month data at NANS 2021 in January, with journal publications thereafter. In total, Nevro is expected to have a very large presence with several data presentations at the conference, including PDN and NSRBP.

 

Webcast and Conference Call Information

Management will host a conference call today at 1:30 pm PT/ 4:30 pm ET.  Investors interested in listening to the call may do so by dialing (866) 324-3683 in the U.S. or +1 (509) 844-0959 internationally, using Conference ID: 6693376.  In addition, a live webcast, as well as an archived recording, will be available on the “Investors” section of the Company’s website at: www.nevro.com.

 

About Nevro

Headquartered in Redwood City, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain.  Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies.  The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's

Page | 2

 


 

 

proprietary HF10® therapy. Senza, Senza II, Senza Omnia, HF10, Nevro and the Nevro logo are trademarks of Nevro Corp.  

 

To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram.

 

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements reflecting the Company’s current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our expectations for roughly flat Q4 2020 revenues compared to the similar prior year period; our expectation that we will present the next round of complete six-month PDN data, along with a preview of 12-month responder rate data, at NANS in January of 2021; our plans to submit the PDN-related PMA Supplement to the FDA in the fourth quarter of 2020 and to commercially launch in the second half of 2021; and our plan to present the NSRBP study three-month data at NANS 2021 with journal publications thereafter. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated growth and the costs and expenses of operating our business; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those that are described in greater detail in our Quarterly Report on Form 10-Q that we expect to file on November 5, 2020, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. Nevro’s operating results for the third quarter ended September 30, 2020 are not necessarily indicative of our operating results for any future periods.

 

Investor Relations:

Matt Bacso, CFA

ir@nevro.com

 

 

 

 

 

 

 

Page | 3

 


 

 

 

Nevro Corp.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

 


 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

 

(unaudited)

 

Revenue

 

$

108,460

 

 

$

100,162

 

 

$

252,317

 

 

$

275,881

 

Cost of revenue

 

 

32,383

 

 

 

30,222

 

 

 

80,443

 

 

 

88,789

 

Gross profit

 

 

76,077

 

 

 

69,940

 

 

 

171,874

 

 

 

187,092

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

11,114

 

 

 

13,019

 

 

 

33,770

 

 

 

42,084

 

Sales, general and administrative

 

 

68,512

 

 

 

72,905

 

 

 

200,081

 

 

 

229,806

 

Total operating expenses

 

 

79,626

 

 

 

85,924

 

 

 

233,851

 

 

 

271,890

 

Loss from operations

 

 

(3,549

)

 

 

(15,984

)

 

 

(61,977

)

 

 

(84,798

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income (expense), net

 

 

(5,826

)

 

 

(1,152

)

 

 

(12,756

)

 

 

(3,512

)

Other income (expense), net

 

 

(402

)

 

 

(291

)

 

 

(645

)

 

 

(516

)

Loss before income taxes

 

 

(9,777

)

 

 

(17,427

)

 

 

(75,378

)

 

 

(88,826

)

Provision for income taxes

 

 

208

 

 

 

420

 

 

 

558

 

 

 

1,118

 

Net loss

 

 

(9,985

)

 

 

(17,847

)

 

 

(75,936

)

 

 

(89,944

)

Changes in foreign currency translation adjustment

 

 

757

 

 

 

200

 

 

 

289

 

 

 

99

 

Changes in unrealized gains (losses) on short-term investments

 

 

(152

)

 

 

 

 

 

73

 

 

 

440

 

Net change in other comprehensive loss

 

 

605

 

 

 

200

 

 

 

362

 

 

 

539

 

Comprehensive Loss

 

$

(9,380

)

 

$

(17,647

)

 

$

(75,574

)

 

$

(89,405

)

Net loss per share, basic and diluted

 

$

(0.29

)

 

$

(0.58

)

 

$

(2.27

)

 

$

(2.93

)

Weighted average shares used to compute

   net loss per share, basic and diluted

 

 

34,356,936

 

 

 

30,929,938

 

 

 

33,398,454

 

 

 

30,659,117

 

 


Page | 4

 


 

 

Nevro Corp.

Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

118,628

 

 

$

65,373

 

Short-term investments

 

 

454,243

 

 

 

172,429

 

Accounts receivable, net

 

 

78,722

 

 

 

82,833

 

Inventories, net

 

 

84,149

 

 

 

91,579

 

Prepaid expenses and other current assets

 

 

6,517

 

 

 

9,838

 

Total current assets

 

 

742,259

 

 

 

422,052

 

Property and equipment, net

 

 

12,234

 

 

 

11,766

 

Operating lease assets

 

 

19,012

 

 

 

21,533

 

Other assets

 

 

3,983

 

 

 

13,338

 

Restricted cash

 

 

956

 

 

 

956

 

Total assets

 

$

778,444

 

 

$

469,645

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

24,473

 

 

$

16,048

 

Short-term debt

 

 

166,608

 

 

 

 

Accrued liabilities and other

 

 

48,350

 

 

 

54,563

 

Total current liabilities

 

 

239,431

 

 

 

70,611

 

Long-term debt

 

 

139,504

 

 

 

160,300

 

Long-term operating lease liabilities

 

 

17,670

 

 

 

20,445

 

Other long-term liabilities

 

 

2,059

 

 

 

1,937

 

Total liabilities

 

 

398,664

 

 

 

253,293

 

Stockholders’ equity

 

 

 

 

 

 

 

 

Common stock, $0.001 par value, 290,000,000 shares authorized,

  34,419,299 and 31,544,361 shares issued and outstanding at

  September 30, 2020 and December 31, 2019, respectively

 

 

35

 

 

 

32

 

Additional paid-in capital

 

 

865,400

 

 

 

626,401

 

Accumulated other comprehensive loss

 

 

49

 

 

 

(313

)

Accumulated deficit

 

 

(485,704

)

 

 

(409,768

)

Total stockholders’ equity

 

 

379,780

 

 

 

216,352

 

Total liabilities and stockholders’ equity

 

$

778,444

 

 

$

469,645

 

 

 


Page | 5

 


 

 

Nevro Corp.

GAAP to Adjusted EBITDA Reconciliation

(unaudited)

(in thousands)

 

The following table presents a reconciliation of GAAP net loss, as prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), to Adjusted EBITDA, a non-GAAP financial measure.

 

Reconciliation of actual results:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

 

(unaudited)

 

GAAP Net loss

 

$

(9,985

)

 

$

(17,847

)

 

$

(75,936

)

 

$

(89,944

)

Non-GAAP Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest (income) expense, net

 

 

5,826

 

 

 

1,152

 

 

 

12,756

 

 

 

3,512

 

Provision for income taxes

 

 

208

 

 

 

420

 

 

 

558

 

 

 

1,118

 

Depreciation and amortization

 

 

1,215

 

 

 

1,152

 

 

 

3,776

 

 

 

3,428

 

Stock-based compensation expense

 

 

13,966

 

 

 

11,197

 

 

 

32,537

 

 

 

31,320

 

Litigation related expenses

 

 

2,330

 

 

 

1,930

 

 

 

6,787

 

 

 

8,731

 

Adjusted EBITDA

 

$

13,560

 

 

$

(1,996

)

 

$

(19,522

)

 

$

(41,835

)

 

Management uses certain non-GAAP financial measures, most specifically Adjusted EBITDA, as a supplement to GAAP financial measures to further evaluate the Company’s operating performance period over period, analyze the underlying business trends, assess performance relative to competitors and establish operational objectives.

 

Management believes it is important to provide investors with the same non-GAAP metrics it uses to evaluate the performance and underlying trends of the Company’s business operations to facilitate comparisons to its historical operating results and evaluate the effectiveness of its operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of the Company’s underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

 

EBITDA is a non-GAAP financial measure, which is calculated by adding interest income and expense, net; provision for income taxes; and depreciation and amortization to net income.  In calculating Adjusted EBITDA, the Company further adjusts for the following items:

 

 

Stock-based compensation expense – The Company excludes non-cash costs related to the Company’s stock-based plans, which include stock options, restricted stock units and performance-based restricted stock units as these expenses do not require cash settlement from the Company.

 

 

Litigation related expenses – The Company excludes legal and professional fees associated with certain legal matters which management considers not related to the underlying operating performance of the business.

 

Full year guidance excludes the impact of foreign currency fluctuations.

 

The non-GAAP financial measure should not be considered in isolation from, or as a replacement for, the most directly comparable GAAP financial measures, as it is not prepared in accordance with U.S. GAAP.

 

 

 

 

Page | 6