8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 8, 2015

NEVRO CORP.

(Exact name of registrant as specified in its charter)

Delaware	001-36715	56-2568057
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification Number)

4040 Campbell Avenue

Menlo Park, CA 94025

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 251-0005

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition.

On May 11, 2015, Nevro Corp. (“Nevro” or the “Company”) issued a press release relating to its financial results for the three months ended March 31, 2015. The full text of the press release is furnished herewith as Exhibit 99.1.

The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On May 8, 2015, the Company announced that the U.S. Food and Drug Administration had approved the Company’s premarket approval application (PMA) for the Company’s Senza Spinal Cord Stimulation system. The full text of the press release regarding this event is filed herewith as Exhibit 99.2.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.	Description
99.1	Press release titled “Nevro Reports First Quarter 2015 Financial Results,” dated May 11, 2015.
99.2	Press release titled “Nevro Receives FDA Approval for Senza® Spinal Cord Stimulation System Delivering HF10™ Therapy,” dated May 8, 2015.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	NEVRO CORP.
Date: May 11, 2015	By:	/s/ Andrew Galligan
		Andrew Galligan
		Chief Financial Officer

EX-99.1

Exhibit 99.1

Nevro Reports First Quarter 2015 Financial Results

Menlo Park, Calif., May 11, 2015 - Nevro Corp. (NYSE:NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today reported financial results for the three months ended March 31, 2015.

Recent Accomplishments & Highlights:

• Revenue of $9.7 million in the first quarter of 2015, an increase of 45% as reported and 70% on a constant currency basis over the same period of the prior year

• On May 8, 2015, received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Senza Spinal Cord Stimulation (SCS) system

• HF10 therapy labeled as superior to traditional SCS therapy for chronic back and leg pain

• HF10 therapy is the only SCS therapy indicated by FDA to deliver pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS therapy)

• Clinical trial investigators scheduled to present 18-month Senza RCT results at International Neuromodulation Society (INS) 12^th World Congress in Montreal in June 2015

• Senza RCT 18-month results selected as 2015 “Best Clinical Abstract” at the International Spine Intervention Society in Las Vegas in July 2015

“I am pleased that adoption of HF10 therapy has continued at a strong pace in the first quarter in European Union and Australian markets,” said Michael DeMane, Chairman and CEO of Nevro. “As a result, more patients in need are afforded the benefits of Nevro’s best-in-class spinal cord stimulation technology. Now, with PMA approval and the first FDA SCS superiority label, these meaningful patient benefits will for the first time be made available to U.S. chronic pain patients.”

First Quarter Financial Results

Revenue for the three months ended March 31, 2015 was $9.7 million versus $6.7 million during the same period of the prior year, representing 45% growth as reported, or 70% growth on a constant currency basis. The net revenue increase was primarily attributable to continued adoption of the Senza system.

Gross profit for the three months ended March 31, 2015 was $5.8 million, representing a 60% gross margin, up from $3.7 million, representing a 55% gross margin, in the same period of the prior year. Product costs as a percent of revenue decreased as average cost per unit benefited from economies of scale with higher unit volumes compared to the same period last year. While revenues were negatively impacted by the appreciation of the U.S. dollar, costs were primarily incurred in U.S. dollars, which negatively impacted the overall gross margin for the period.

Operating expenses for the three months ended March 31, 2015 were $18.1 million, an increase of 66% compared to $10.9 million in the same period of the prior year. The increase in operating expenses was driven primarily by increased headcount and related personnel costs for the sales and marketing organization in preparation for the U.S. commercial launch as well as an increase in general and administrative costs associated with being a public company.

Loss from operations for the first quarter of 2015 was $12.3 million, compared to $7.2 million for the same period of the prior year.

Guidance for Full Year 2015

The company is reiterating its previously issued guidance, estimating international revenue for the full year 2015 to be in the range of $36 to $38 million, which represents an increase from 2014 in the range of 10.5% to 16.7% on a reported basis, and the range of 25.8% to 32.8% using foreign exchange rates from the first quarter of 2015.

Webcast and Conference Call Information

Management will host a conference call today beginning at 5:30 a.m. PT / 8:30 a.m. ET. Individuals interested in listening to the conference call may dial (877) 201-0168 for domestic callers, or (647) 788-4901 for international callers (Conference ID: 41475428), or access the webcast on the “Investors” section of the Company’s web site at: www.nevro.com. The webcast will be available on the Company’s web site for two weeks following the completion of the call.

About Nevro

Headquartered in Menlo Park, California, Nevro is a 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 neuromodulation platform for the treatment of chronic pain. The Senza system is the only SCS system that delivers Nevro’s proprietary HF10™ therapy. Senza, HF10, Nevro and the Nevro logo are trademarks of Nevro.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements with respect to our business, capital resources, strategic initiatives and growth reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including regarding our beliefs about making Senza available in the United States; continuing adoption of Senza in international markets; and our expectations for international revenue for the full year 2015. 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; the timing of our U.S. commercial launch of Senza; 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; 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 Annual Report on Form 10-K filed on March 18, 2015 and our Quarterly Report on Form 10-Q that we expect to file on May 11, 2015, as well as any reports that we may file with the SEC 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. Our results for the quarter ended March 31, 2015 are not necessarily indicative of our operating results for any future periods.

Investor Relations Contact:

Westwicke Partners

Lynn Pieper

(415) 202-5678

Lynn.pieper@westwicke.com

Nevro Corp.

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

	Three Months Ended March 31,
	2015			2014
	(unaudited)
Revenue	$	9,662		$	6,664
Cost of revenue		3,873			2,999
Gross profit		5,789			3,665
Operating expenses:
Research and development		4,998			4,696
Sales, general and administrative		13,130			6,210
Total operating expenses		18,128			10,906
Loss from operations		(12,339	)		(7,241	)
Other income (expense):
Interest income (expense), net		(569	)		40
Other income (expense), net		(1,010	)		238
Loss before income taxes		(13,918	)		(6,963	)
Provision for income taxes		142			93
Net loss		(14,060	)		(7,056	)
Accretion of convertible preferred stock to redemption value		—			(43	)
Net loss attributable to common stockholders		(14,060	)		(7,099	)
Changes in foreign currency translation adjustment		(123	)		—
Changes in gains (losses) on short-term investments		(79	)		(13	)
Net change in other comprehensive loss		(202	)		(13	)
Comprehensive loss	$	(14,262	)	$	(7,112	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.57	)	$	(6.60	)
Weighted average shares used to compute net loss per share, basic and diluted		24,849,229			1,075,932

Nevro Corp.

Consolidated Balance Sheets

(in thousands, except share and per share data)

	March 31, 2015			December 31, 2014
	(unaudited)
Assets
Current assets
Cash and cash equivalents	$	21,984		$	25,287
Short-term investments		137,232			151,521
Accounts receivable, net		7,314			6,610
Inventories, net		18,236			14,856
Prepaid expenses and other current assets		3,026			2,851
Total current assets		187,792			201,125
Property and equipment, net		1,189			647
Other assets		2,333			424
Restricted cash		906			300
Total assets	$	192,220		$	202,496
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	8,151		$	4,460
Accrued liabilities and other		5,278			6,338
Total current liabilities		13,429			10,798
Notes payable		19,569			19,511
Other long-term liabilities		104			117
Total liabilities		33,102			30,426
Stockholders’ equity
Common stock, $0.001 par value – 290,000,000 shares authorized, 24,896,511 and 24,865,491 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively		25			25
Additional paid-in capital		295,255			293,945
Accumulated other comprehensive income (loss)		(125	)		77
Accumulated deficit		(136,037	)		(121,977	)
Total stockholders’ equity		159,118			172,070
Total liabilities and stockholders’ equity	$	192,220		$	202,496

EX-99.2

Exhibit 99.2

Nevro Receives FDA Approval for Senza^® Spinal Cord Stimulation System Delivering HF10™ Therapy

HF10 Therapy Labeled as Superior to Traditional SCS Therapy for Chronic Back and Leg Pain

Conference Call on Monday, May 11 at 8:30 a.m. ET to Discuss the FDA Approval

and Operating Results for the First Quarter 2015

MENLO PARK, Calif., May 8, 2015 /PRNewswire/ — Nevro Corp. (NYSE: NVRO), a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS) system. Nevro also announced that it will now be releasing financial results for the first quarter of 2015 before market open on Monday, May 11, 2015. The Company will be hosting a conference call beginning at 8:30 a.m. Eastern Time to discuss both the FDA approval and first quarter operating results on Monday, May 11, 2015, in place of the conference call previously scheduled in the afternoon of the same day.

The Senza SCS system, which delivers Nevro’s proprietary HF10 therapy, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The Senza system delivering HF10 therapy has experienced strong adoption in Europe and Australia over the past 5 years. With this FDA approval, patients in the U.S. suffering from chronic pain will have the opportunity to experience the significant benefits of HF10 therapy. FDA approval of Nevro’s Senza system highlights the unique nature of the technological innovation:

• HF10 therapy is the only SCS therapy approved by FDA with superiority labeling;

• HF10 therapy is the only SCS therapy indicated by FDA to deliver pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS);

• HF10 therapy is the only SCS therapy approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy; and

• The Senza system is the only implantable SCS system approved by FDA with labeling for 3T conditional MRI compatibility.

The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to directly compare SCS therapies. The multicenter study was conducted across 11 U.S. clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients, making it the largest prospective randomized SCS study ever conducted to assess the treatment of chronic back and leg pain.

“My fellow investigators and I have eagerly awaited the approval of the Senza SCS system,” said Dr. Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center. “The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional SCS, representing a tangible advance in chronic pain management. HF10 therapy will allow me to help more patients in my practice by addressing back pain in addition to leg pain. And, with HF10 therapy I can for the first time focus on providing pain relief to my patients instead of managing paresthesia, which is a paradigm shift for my pain practice.”

The labeling for the Senza system and HF10 therapy was based on the SENZA-RCT clinical trial, where HF10 therapy was meaningfully superior to traditional SCS therapy for back and leg pain, including superior response rates, pain relief, and functional outcomes. Superiority was demonstrated in the primary and all secondary endpoints including at every measurement time point throughout the 12 month follow up.

“We are grateful to the inspiring dedication of the clinical investigators, their study coordinators, and patients involved in the SENZA-RCT study, as they collectively have paved the way for this therapy to help those suffering from debilitating chronic pain,” said Michael DeMane, Chairman and Chief Executive Officer of Nevro. “The Nevro organization is prepared to initiate a responsible rollout of HF10 therapy to the U.S. pain management community and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company.”

Investor Conference Call

Nevro will host an investor conference call beginning at 8:30 a.m. Eastern Time to discuss both the FDA approval and the first quarter operating results on Monday, May 11, 2015, in place of the conference call previously scheduled in the afternoon of the same day. The conference call can be accessed by dialing (877) 201-0168 domestically and (647) 788-4901 internationally (Conference ID: 41475428), or from the webcast on the “Investors” section of the company’s website at: www.nevro.com. The webcast will be available on the company’s website for two weeks following the completion of the call.

About the Senza System and HF10 Therapy

The Senza system is the only SCS system that delivers Nevro’s proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS therapy) and is also the first SCS therapy to demonstrate superiority to traditional SCS for back and leg pain in a comparative pivotal study. Nevro’s innovations in SCS, including the SENZA^® system and HF10™ therapy, are covered by more than 75 issued U.S. and international patents.

About Nevro

Headquartered in Menlo Park, California, Nevro is a 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 neuromodulation platform for the treatment of chronic pain. The Senza system is the only SCS system that delivers Nevro’s proprietary HF10 therapy. Senza, HF10, Nevro and the Nevro logo are trademarks of Nevro.

Forward-Looking Statements

In addition to historical information, this press release may contain forward-looking statements with respect to our business, capital resources, strategic initiatives and growth reflecting the current beliefs

and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including with respect to our beliefs and expectations regarding the opportunity for U.S. patients to experience significant benefits from HF10 therapy, the effects of HF10 therapy on current pain management practices, and our initiation of a responsible rollout of HF10 therapy in the U.S. 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; the timing of our U.S. commercial launch of Senza; 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; 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 Annual Report on Form 10-K filed with the SEC on March 18, 2015, as well as any reports that we may file with the SEC 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.

Investor Relations Contact:

Westwicke Partners

Lynn Pieper

(415) 202-5678

Lynn.pieper@westwicke.com