JUNE 2016 [ 1 ]
Forward Looking Statements SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS In addition to historical information, this presentation 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 continuing adoption of, and interest in, Senza in the U.S. and international markets; our beliefs regarding market size and share for Senza; our beliefs regarding the advantages of Senza and HF10 therapy; our expectations regarding our commercialization efforts, including sales force expansion and the launch of our surgical lead; and our expectations for worldwide revenue for the full year 2016. 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; 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 February 29, 2016 and our Quarterly Report on Form 10-Q filed on May 9, 2016, 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. [ 2 ]
Nevro: A Leader in Neuromodulation DIFFERENTIATED Technology Superior to Traditional SCS and Protected by 100+ Patents ATTRACTIVE Market Growing $1.7B Market, Existing Reimbursement, Potential to Take Share and Grow Existing Market FIRST in Class Evidence First Pivotal RCT with Comparative Effectiveness Data, All Primary and Secondary Endpoints Met DEMONSTRATED Execution Commercial Success in United States, Europe and Australia PLATFORM Potential Market Expansion by Treating Back Pain and Other Indication Expansion Opportunities 7,000+ Patients in 17 MARKETS Over 5 YEARS [ 3 ]
Recent Highlights FDA Approval & Superiority Labeling for HF10 Therapy 12-Month Publication in Anesthesiology 12 Month SENZA-RCT Results published in Anesthesiology (titled Novel 10 KHz High Frequency Therapy (HF10 Therapy) Is Superior to Traditional Low Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial ) IPR Patent Challenge Victory U.S. Patent and Trademark Office denied Boston Scientific Petitions for Inter Partes Review of U.S. Patent No. 8,359,102 CMS Approval of Transitional Pass-Through Payment Centers for Medicare & Medicaid Services (CMS) Approves a Transitional Pass-Through Payment for High Frequency Stimulation under the Medicare Hospital Outpatient Prospective Payment System Effective Beginning January 1, 2016 Consistent International Performance ~70% YoY growth in 1Q15, ~80% growth in 2Q15, ~50% growth in 3Q15, ~55% growth in 4Q15, and ~30% growth in 1Q16 on a constant currency basis Successful US Launch Growing number of clinics across the U.S. are continuing to adopt HF10 therapy and outcomes in commercial use are consistent with clinical outcomes from SENZA-RCT FDA Approval for New Surgical Leads for the Senza SCS System [ 4 ]
Delivering on the Promise of HF10 Therapy FY15 Revenue: $69.6M U.S. Reps Trained & In Field $ in Millions International Revenue U.S. Revenue $41.7 52 70 92 100 113 $33.1 $12.2 At Launch 5/8/15 2Q15 3Q15 4Q15 1Q16 $13.3 $15.4 $9.7 $11.4 $29.5 $10.9 $19.8 $9.7 $11.3 $0.1 $4.5 1Q15 2Q15 3Q15 4Q15 1Q16 Penetrating AND Growing the SCS Market Predom. Back Predom. Leg Back & Leg Other Pain Distribution of HF10 Treated Patients U.S. Launch through Jan 1, 2016 ~50% ~5% ~30% ~15% [ 5 ]