Investor Presentation - May 2019 - Investor Relations | Avedro
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Investor Presentation May 2019
Safe Harbor Statement This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements about the market opportunity for the Avedro Corneal Remodeling Platform and the rate of adoption of FDA approved cross-linking procedures. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” “anticipates,” and “future” or similar expressions are intended to identify forward-looking statements. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of risks and uncertainties and other important factors, any of which could cause Avedro’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Avedro’s quarterly report on Form 10-Q filed May 9, 2019 as well as discussions of potential risks, uncertainties and other important factors in Avedro’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Avedro undertakes no duty to update this information unless required by law. 2
Novel Solutions for Sight Threatening Diseases
TRANSFORMING THE TREATMENT OF SIGHT DISORDERS
$3 billion U.S. >95% of 130 peer-
Robust Strong financial
market commercial reviewed
pipeline position
opportunity 1 lives covered publications
1 – U.S. Keratoconus Market
Pipeline Expansion $23B+ Market Opportunity
3
It’s estimated 1 out of every 545
Keratoconus: people in the U.S. have
A sight-threatening disease keratoconus
Market Scope 2018
2,000
“He was getting worse,
1 out of 5 people 1,800
1,600
we kept going to the
with keratoconus will Awareness 1,400
1,200
doctor and saying ‘Hey,
need a corneal is growing 1,000
800
he is really struggling
transplant 600
400
200
with this’”
Survey of Ophthalmology - 1998 0 April 5, 2019
“For all his career, his life even, Steph Curry
Keratoconus usually
has had issues with his eyes. He said he
has a condition called Keratoconus” begins in the teenage
years
The Athletic - April 5, 2019
4
Keratoconus
~600,000* patients
~1.2M eyes
~$3B 17,000* new
patients annually
U.S. Market
>95% insured
covered lives
5 * Market Scope 2018
Minimally Invasive Strengthening of the Cornea
Corneal cross-linking (CXL)
Normal
Biochemical technique utilizing Cornea
photoactivation to create bonds between
the collagen fibers in the eye
Halts progressively thinning and
weakening corneas
Modifies the shape of the cornea, the Diseased
eye’s outermost lens, responsible for 65% Cornea
to 75% of the eye’s total focusing power
Over 400,000 cross-linking procedures have been performed globally
6
The Avedro Solution
KXL System • First and only FDA-approved minimally
Proprietary
computer software invasive treatment for progressive
and UV light keratoconus
• CE Mark
• Well-established procedure and no special
training required
Photrexa® and • High clinical success rate
Photrexa® Viscous
Proprietary single-use drug • Easily integrates into clinician practice
formulations
• Strong reimbursement to clinician
7
How Corneal Cross-Linking Works (Epi-Off)
1 2
• Physicians familiar
with every step
• One-case training
Removing the Photrexa® and Photrexa ® Viscous
epithelium “Epi-Off” applied to the cornea
3 4
UV illumination applied Cornea post procedure
8
Clinical Data Highlights and Publications
10
Years of CXL
15
Clinical
130+
Peer-reviewed
follow-up trials publications
Corneal collagen crosslinking with riboflavin and ultraviolet-A light in progressive keratoconus: Ten-year results
Frederick Raiskup, MD, PhD, FEBO, Anja Theuring, MD, Lutz E. Pillunat, MD, Eberhard Spoerl, PhD
✓ Achieved long-term stabilization ✓ Strong safety profile
✓ Easy to perform ✓ Reduced the need for corneal transplantation
9
Reimbursement in Place
All national and most large regional payers are covering the Avedro Corneal Cross-linking Solution
Drug Procedure Eval & Mgmt
January 1, 2019 - CMS Granted a Category III No global period for the T-code
product-specific J Code Current Procedural
became effective Terminology (CPT) code Physicians bill insurance for
the pre-op and post-op
Insurance companies are Physicians are currently evaluations and management
treating Photrexa reimbursed per their contracts of patients
reimbursement as a pass- with the private payers
through to the refractive
surgery center
10Reimbursement Support
$
ARCH Portal Educational Support Reimbursement Resources
Pre-service and post-service In-person field support and Sample claim forms and other
support such as benefits webinars for information on payer resources to help navigate
investigation and denial mgmt coverage, coding, and billing the reimbursement process
11Opportunities to Drive Growth
Grow Mindshare Expand Market Leverage Pipeline
PiXL
Epi-On for refractive
Broaden for progressive vision
Expand KXL System keratoconus correction
Drive Awareness of installations
Simplify KXL System Keratoconus
Reimbur- utilization
sement
Near-Term 6 – 18 months Mid-Term 1 – 3 years Long-Term > 3 years
12Clinical Trials
Program 2018 2019 2020 2021
Epi-On Keratoconus
FDA SPA agreement March 2018
Phase 3 (U.S.) in
Fully enrolled May 1, 2019
Progressive Keratoconus
1 Year follow-up May, 2020
Vision Correction with PiXL
Phase 2a Designed to optimize the parameters
Presbyopia (Intl.) of PiXL
Next Clinical Phase Trial design will be based on the
Presbyopia (U.S.) Phase 2a results
13Epi-On Phase III Trial – Enrollment Complete
Multicenter, randomized, sham-controlled trial (14 U.S. clinical sites) • Non-invasive – no
epithelial removal
>275 Eyes • Improved comfort
and recovery time
• New drug
Treated Eyes Placebo Eyes formulations
• Latest-generation
Assessed at day 1, day 3, week 1 and KXL system,
months 1, 3, 6 and 12 including Boost
Goggles with O2
Primary endpoint is a statistically significant differential of equal • Potential three year
to or greater than 1.0D in change in Kmax from baseline over a exclusivity
six-month period between the treatment and placebo groups
14U.S. Vision Correction Opportunity
$15B $8B $180M
Presbyopia Low Myopia Post Cataract IOLs
>50 million people ~13.5 million people ~600,000 eyes annually
Gradual loss of the eyes' Mild nearsightedness Poor vision following
ability to focus on nearby cataract procedure
objects Largest segment of low
myopia patients is under Target population is the
Affects everyone after the 45 years of age who have ~50% of post-cataract
age of 40 refractive conditions patients who do not
achieve their target
distance vision without
glasses
15PiXL
Designed to Achieve:
Mosaic System
• Non-invasive vision correction Proprietary
computer software
and UVA beam
• Targeted corneal reshaping with customized forming technology
cross-linking
• Drops and UV light alternative to Lasik and
IOLS Boost Goggles
• Long-term durability
• Spectacle independence
New Drug
• No halos or loss of corrected distance vision Formulation
Proprietary single-use drug
formulations
16
System not approved in the U.S.Financial Summary
1Q 2019 Performance
• 1Q 2019 revenue growth
of 70% year over year
Annual Revenue (millions) First Quarter Revenue (millions) • Increase in gross margin
CAGR ~38% 70% y/y growth to 74% in 1Q 2019
• Cash and equivalents of
$8.8 $64.8M as of 3/31/19
$37.0 - $40.0
$5.2 2019 Expectations
$27.7
• 2019 annual revenue
$20.2 guidance $37M - $40M
• 2019 gross margins
70% - 75%
2017 2018 2019 2018 2019 • 2019 KXL Installed base >
360 systems
17Management Team Reza Zadno, PhD President and Chief Executive Officer ………………………………………………………………………………………………………………….. Tom Griffin Chief Financial Officer ………………………………………………………………………………………………………………….. Rajesh Rajpal, MD Chief Medical Officer ………………………………………………………………………………………………………………….. Paul Bavier General Counsel & Chief Compliance Officer ………………………………………………………………………………………………………………….. Jim Schuermann Chief Business Officer 18
Takeaway Summary
Currently addressing $3 billion keratoconus market in the U.S.
Comprehensive pipeline to address $23 billion vision correction market in the U.S.
Strong financial position
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