Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
Conquering Upper Limb Paralysis with Wearable Medical Robotics
Investor Presentation
May 2019
Paul R. Gudonis, Chairman and CEO
David Henry, CFO
NYSE American: MYO
1
Legal Disclaimer
This presentation contains forward-looking statements regarding the trading of the Company’s common stock on the NYSE American, the Company’s plans for the use of proceeds and advancing its product line, increasing its sales and marketing efforts and growing its business, and the Company's future business expectations, which are based upon the current estimates, assumptions and expectations of the Company’s management and its knowledge of the relevant market. The Company has tried, where possible, to identify such information and statements by using words such as “anticipate,” “believe,” “envision,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. Forward-looking statements, which are included in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, are only predictions and may differ materially from actual results due to a variety risks, uncertainties and other factors. These risks and uncertainties include, among others, risks related to the Company’s liquidity and financial position, the trading of its common stock, its new products, services, and technologies, government regulation and taxation, and fraud. More information about factors that potentially could affect Myomo's business and financial results are included in Myomo's Form S-1 Registration Statement filed with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
2
Why Invest in MYO Now?
Large Unmet Medical Need: Upper Extremity Paralysis
Only Commercially-Available Device to Restore Function
• FDA Registered in US; CE Mark in Europe
Reimbursed on Case-by-Case Basis by Commercial Payers; Approved by VA for Veterans
• Awaiting Coverage Policy & Payment by Medicare for New Codes Effective January 1st
National Rollout Underway in US with Direct-to-Patient Marketing
• Increasing Pipeline; Higher ASP and Gross Margin
Record Revenue and Gross Margin in 2018
• Significant Revenue Growth Expected in 2019
3
News Story
4
Current Upper Extremity Treatment Options
Rehabilitation
➢ Occupational Therapy
➢ Static Bracing
➢ Saebo
➢ Electrical Stimulation (Bioness)
➢ Stationary Robotics
Medical
➢ Botox
➢ Baclofen
5
Brain Signal
EMG
Sensor
Signal Processing
Movement
MyoPro Orthosis: How it Works
6
CAUSES OF UPPER
EXTREMITY PARALYSIS
STROKE BRACHIAL PLEXUS
INJURY SPINAL CORD
INJURY
MULTIPLE
SCLEROSIS
TRAUMATIC
BRAIN INJURY
ALS
25% of 3M existing cases of upper extremity paralysis $10 B Total US Market Size
25% of 350k new cases each year $1.2 B New Incidences / Year +
US + EU + ROW $30 B Estimate Includes:
Total US Market Potential
Total Worldwide Market Potential
*Source: Christopher and Dana Reeve Foundation Survey,
National Stroke Association, World Health Organization, and
Myomo Base Model Estimates
Large Market Opportunity*
7
Myomo Commercialization + Scale-Up Timeline
8
2016 2017 2018 2019
Controlled Introduction
Raising Growth Capital
National Rollout and Direct to Patient Advertising
• IPO and Follow-on Offering = $19.2 M
• MyoPro 2 Product Line
• CE Mark
• Applied to CMS for HCPCS Codes
• Growing Pipeline
• Raised $5.6M
• International Distribution
• 400 Screening Days
• Pediatric Device Q4
Revenue = $1.0M Revenue = $1.6M Revenue = $2.4M Revenue = Q1 $830K
165%↑
Scaling Up
• MyoPro 1 Product Line
• Limited # of US Markets
• Clinical Research and Initial Reimbursements
• VA Approval
• Chief Commercial Officer & National Sales Team
• B2C Ads
• 200 Screening Days
• 2 HCPCS Codes Issued
Lower Limb
Products
Upper Limb
Products
Lower Limb Products
Upper Limb Products
Exoskeletons Foot Drop
Only Commercially Available Upper Limb Product Line to Restore Function
Unit Volume
Orthotics Prosthetics
Stance Control
Competitive Landscape of O&P and Robotics
9
Wheelchair
PRODUCT and MFG.
Manufacturing and Distribution
DISTRIBUTION
EU Distributors
Centers of Excellence O&P Clinics
10
Direct Billing
Expanding O&P Distribution Footprint (Top 50 MSA’s)
11
Generating Leads with Digital Marketing
12
Organizing Screening Days Nationwide
15
Wichita, Kansas - Wednesday, May 22nd
Lansing, Michigan - Thursday, May 23rd
Boston, Massachusetts - Thursday, May 23rd
Spokane, Washington - Friday, May 24th
Portland, Maine - Friday, May 24th
Traverse City, Michigan - Friday, May 24th
St. Louis, Missouri - Friday, May 24th
Sacramento, California - Wednesday, May 29th
Livonia, Michigan - Wednesday, May 29th
Pittsburgh, Pennsylvania - Wednesday, May
29th
New York City, New York - Wednesday, May
29th
Nassau County, New York - Thursday, May 30th
Bakersfield, California - Thursday, May 30th
Springfield, Missouri - Thursday, May 30th
Santa Clarita, California - Friday, May 31st
Austin, Texas - Monday, June 3rd
Hartford, Connecticut - Tuesday, June 4th
Royal Oak, Michigan - Tuesday, June 4th
Portland, Oregon - Tuesday, June 4th
Chicago, Illinois - Tuesday, June 4th
Madison, Wisconsin - Wednesday, June 5th
Milwaukee, Wisconsin - Wednesday, June 5th
Seattle, Washington - Thursday, June 6th
Albany, New York - Thursday, June 6th
Walnut Creek, California - Tuesday, June 11th
San Francisco, California - Wednesday, June
12th
Boston, Massachusetts - Wednesday, June 12th
San Jose, California - Thursday, June 13th
Ann Arbor, Michigan - Thursday, June 13th
Traverse City, Michigan - Friday, June 14th
East Lyme, Connecticut - Tuesday, June 18th
Salt Lake City, Utah - Wednesday, June 19th
Livonia, Michigan - Wednesday, June 19th
Boston, Massachusetts - Thursday, June 20th
Spokane, Washington - Friday, June 21st
Grand Rapids, Michigan - Friday, June 21st
St. Louis, Missouri - Monday, June 24th
Sacramento, California - Tuesday, June 25th
Southern New Jersey - Tuesday, June 25th
Detroit, Michigan - Tuesday, June 25th
Bakersfield, California - Tuesday, June 25th
Nassau County, New York - Wednesday, June
26th
Clinton Township, Michigan - Wednesday, June
26th
Santa Clarita, California - Thursday, June 27th
New York City, New York - Thursday, June 27th
Which screening day would you like to
attend?
New York Area - Multiple Dates
Austin, Texas - Monday, May 6th
Portland, Oregon - Tuesday, May 7th
Royal Oak, Michigan - Tuesday, May 7th
Raleigh, North Carolina - Wednesday, May
8th
Southern Vermont - Thursday, May 9th
Ann Arbor, Michigan - Thursday, May 9th
Seattle, Washington - Thursday, May 9th
Belleville, Illinois - Thursday, May 9th
Warner Robins, Georgia - Monday, May 13th
Southern New Jersey - Tuesday, May 14th
Minneapolis, Minnesota - Tuesday, May 14th
Los Angeles, California - Wednesday, May
15th
San Francisco, California - Wednesday, May
15th
San Jose, California - Thursday, May 16th
Munster, Indiana - Thursday, May 16th
Houston, Texas - Friday, May 17th
Grand Rapids, Michigan - Friday, May 17th
Columbia, Missouri - Friday, May 17th
Walnut Creek, California - Tuesday, May 21st
Salt Lake City, Utah - Wednesday, May 22nd
Livonia, Michigan - Wednesday, May 22nd
More Screening Days Growing Patient Pipeline
16
0
20
40
60
80
100
120
140
Q1 Q2 Q3 Q4 Q1
Screening Days in 2018-2019
.
Strong Growth in Quarterly Revenues (YoY)
17
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000
900,000
1,000,000
1Q 2Q 3Q 4Q2016 2017 2018 2019
+25%
+63%
+165%
+106%
… And Increased ASP and Gross Margin %
Q1 2018 Q1 2019
$23,700
$22,000
ASP
18
Q1 2018 Q1 2019
79%
65%
Catalysts: Product Mix / Channel / Direct Billing
GM%
Product Development to Expand Market
ADULTS (MyoPro2 JUNE 2017)
ADOLESCENTS (JUNE 2018)
PEDIATRICS (2019E)
19
Reimbursement by Various Payers
20
Approvals on Case by Approved for Vets Issued New Case Basis HCPCS Codes Billed by O&P Provider 40+ VAMC’s Pending Coverage and Payment Amt. New Direct Billing
Commercial Payers Military Medicare
Growing # MyoPro Units in Reimbursement Process
21
6/30/18
Previous Cases Pending
Reimbursement
92
222 167
243
139
111
92
222
306
354
Screening Insurance Authorization Order
9/30/18 12/31/18 3/31/19
New Unit Adds in Q1
22
More Patient Cases Progressing through the Reimbursement Process
112
203
194
151
Q4 2018 Q1 2019
Total # of Cases PostEvaluation/Pre Submission
Total # of Cases withPre-Authorization Submittedand Pending Approval
306
354
Entering International Markets
23 23
European Target Countries
Established Myomo Business Development Office in Europe
Recruited O&P Providers in Germany, Denmark, UK, Italy Conducting Screening Days and Building Patient Pipeline
24 24
Setting The Stage For a Strong 2019
25
Expect to grow revenues significantly in 2019
Revenue Gross Margin
313
830
Q1'18 Q1'19
165%
65%
79%
Q1'18 Q1'19
00
0’s
Investments to Support Revenue Growth
26
Begin to drive operating leverage in the business in 2019
Investments in: • Product Development • Marketing and Clinical Support • Reimbursement Team
Operating Expenses
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19
Cash Position
27
Current burn rate $800K - $1M per month
Generate operating leverage in 2019 to start to reduce the cash burn
-3.5
-3.0
-2.5
-2.0
-1.5
-1.0
-0.5
0.0
Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19
$ M
illio
ns
Operating Cash Flow
Seasonal reduction in liabilities
2019 Cash Guidance
28
We believe our cash balance at March 31, 2019 is sufficient to fund operations and capital expenditure requirements in 2019.
Beyond 2019, we believe additional capital is required to
achieve our breakeven target.
Cash Balance Q1’19 - $9.2M
Investor Summary: Catalysts for Growth
29
MYO Current Base
#1: Increased US Distribution & Direct-to-Patient Marketing = More Demand
# 2: New Product Development = More Target Patients
#3: Medicare Reimbursement Potential = Greater Patient
Access
#4: International Markets = More Population