Jefferies Global Healthcare Conference

43
Jefferies Global Healthcare Conference June 6 9th, 2017

Transcript of Jefferies Global Healthcare Conference

Page 1: Jefferies Global Healthcare Conference

Jefferies Global Healthcare Conference

June 6 – 9th, 2017

Page 2: Jefferies Global Healthcare Conference

© 2017 ConforMIS, Inc.

Forward Looking Statements

• This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than

statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future

financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking

statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,”

“will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not

all forward-looking statements contain these identifying words.

• We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not

place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions

and expectations disclosed in the forward-looking statements we make. The forward-looking statements contained in this

presentation reflect our current views with respect to future events, and speak only as of the date of this presentation. We assume

no obligation to update any forward-looking statements.

• Our business is subject to substantial risks and uncertainties, including those referenced in certain of our filings with the SEC under

the heading “Risk Factors.” You are encouraged to read our filings with the SEC, available at www.sec.gov, including our Form S-1

Registration Statement filed with the SEC on May 22, 2015 and the related amendments, as well as our Final Prospectus filed with

the SEC on July 1, 2015 and our quarterly statements filed on Form 10Q. Investors, potential investors, and others should give

careful consideration to these risks and uncertainties.

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Disrupting a $15 Billion Industry

© 2017 ConforMIS, Inc. 3

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Investment Highlights

Proprietary platform technology for customized joint replacement implants

Technology potentially applicable to ~ $15 billion joint replacement market

Broad IP ~ 450 patents and pending patent applications

Clinical data supporting superior clinical outcomes

Potential economic benefits over off-the-shelf implants

Highly scalable business model

© 2017 ConforMIS, Inc. 4

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1 in 5 patients are not satisfied

with the results of their total

knee replacement1

© 2017 ConforMIS, Inc.

Patient Outcomes after Off-the-Shelf TKR

1 According to a study of 1,703 patients published by Bourne in 2009 in the peer-reviewed journal Clinical Orthopaedics and Related Research (In this study entitled Patient Satisfaction after Total

Knee Arthroplasty: Who is Satisfied and Who is Not?, “the overall satisfaction question was used to determine a two-category satisfaction outcome by combining patients who answered very

dissatisfied, dissatisfied, or neutral into one group, and patients who answered satisfied or very satisfied into the second group.”)

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Off-the-Shelf Delivery Model

Knee Example

● 5-10 costly instrumentation trays required

for each procedure

● All instrument trays require set up, break

down and sterilization

● Potential source of costly infections

● Substantial inventory cost of instruments

borne by manufacturer

© 2017 ConforMIS, Inc. 6

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“Patient-Specific” Industry Approach

● Used with reusable instruments

Cost of storing, sterilizing

Risk of infection

OR efficiency and turnover

● Does not change perceived fundamental

shortcomings of off-the-shelf implants

Improper implant fit, overhang, undersizing

Wrong geometry, not matching patient

Residual pain, functional limitations (limited

range of motion, mid-flexion instability)

© 2017 ConforMIS, Inc.

Patient-specific instruments or Robotics Standard, off-the-shelf implant

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● Additional robotics challenges

Cost

OR efficiency and turnover

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A Paradigm Shift in Orthopedics

© 2017 ConforMIS, Inc. 8

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ConforMIS Platform Technology

● ConforMIS products for knee replacement

iTotal PS

iTotal CR

iUni

iDuo

● Potential opportunity to expand iFit technology to:

Hip

Spine

Shoulder

Extremities

Revisions

Resurfacing

● Digitally driven / Just-in-Time manufacturing

● Customized implants

● Patient-specific instruments

© 2017 ConforMIS, Inc. 9

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iFit Design

© 2017 ConforMIS, Inc.

iFit Image-to-Implant Platform Technology

iFit JIT Delivery

Clinical

Benefits

Economic

Benefits

Intra-Op

Benefits

iFit 3D Additive Printing

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ConforMIS Delivery Model: Intraoperative Benefits

● Single-use kit

● Delivered before surgery

● One reusable tray

● Simplified procedure with fewer steps

● Reproducible

© 2017 ConforMIS, Inc. 11

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Why Patients Are Dissatisfied

Post-operative Pain Poor Function

Implant overhang/

under-sizing

Component

malrotation

• Limited range of

motion

• Stiffness

• Knee instability

• Unnatural feel

© 2017 ConforMIS, Inc. 12

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© 2017 ConforMIS, Inc.

Personalized Position, Shape & Fit

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Implant Overhang Leads to Pain

1 Mahoney, et al; Overhang of the Femoral Component in Total Knee Arthroplasty: Risk Factors and Clinical Consequences. The Journal of Bone and Joint Surgery; 2010, 92: 1115-1121

In a study of 437 total knee replacements, the prevalence of overhang ≥ 3mm was high¹

40%

60%

Men

Overhang of ≥ 3mm in at least one zone

< 3mm overhang

32%

68%

Women

Overhang ≥ 3mm associated with an almost

twofold increased risk of pain at two years1

© 2017 ConforMIS, Inc. 14

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Implant Malrotation Leads to Pain

Off-the-shelf implants frequently

not aligned with proper rotational

axis of the knee

In a published study of anterior knee

pain, patients with improper

component rotation were 5X more

likely to experience knee pain1

1 Barrack, et al; Component Rotation and Anterior Knee Pain after Total Knee Arthroplasty. Clinical Orthopaedics and Related Research; 2001, 392: 46-55

© 2017 ConforMIS, Inc. 15

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iTotal recreates patient’s

natural geometryiTotal designed to match natural

curves, corrected for deformities

© 2017 ConforMIS, Inc.

ConforMIS Respects Patient’s Natural Geometry

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One Patient - One Implant

• Recreate and respect patient’s natural geometry

• Personalized shape & fit

• Eliminate implant overhang or under-sizing

• Eliminate implant malrotation

© 2017 ConforMIS, Inc. 17

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© 2017 ConforMIS, Inc.

50.2 mm

36.3 mm

0 10 20 30 40 50

Off-the-shelf

ConforMIS iTotalCR

(n=54)

(n=66)

1 Source: William B. Kurtz, MD. Patient- Specific Knee Replacement Implant Preserve Bone and Decrease Blood Loss & Swelling. Presented at BASK 20132 Source: Slamin, J.E. et al Optimizing Knee Femoral Component Strength and Bone Preservation with Finite Element Analysis. Poster presented at ORS 2012

* Femoral cuts: distal & posterior. Tibial cuts: medial & lateral

Implant design advantage2: customized bone cuts, minimized for the geometry of each individual patient.

Difference of

total thickness is

27.6% (p<0.001)

Thickness of All* Bone Resections1

Total thickness of bone resections in mm

iTotal CR: Bone Preserving Design

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© 2017 ConforMIS, Inc.

1Source: Katthagen et al; International Congress for Joint Reconstruction WAC 2015

20.0%

5.7%

0% 5% 10% 15% 20% 25%

Off-the-shelf

ConforMIS iTotalCR

(n=35)

(n=35)

p=0.15

Ligament releases1

% of patients with ligament releases

iTotal CR: Ligament Preserving Design

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In multiple clinical studies iTotal CR patients have demonstrated better kinematic results compared to

OTS systems (Zimmer Biomet NexGen, Stryker Triathlon, and Zimmer Biomet Vanguard):

More Normal Lateral Roll Back with Deep Knee Bend1

More Normal Lateral Roll Forward with Chair Rise2

No Lift-off in Early/Mid Flexion During Knee Bend3

© 2017 ConforMIS, Inc.

1 Source: Zeller, Komistek et al; International Congress for Joint Reconstruction Pan Pacific 20162 Internal data analysis. Zeller, Komistek et al; International Congress for Joint Reconstruction Pan Pacific 20163 Source: Zeller IM, Sharma A, Kurtz WB, Anderle M, Komistek RD, Customized Versus Patient Matched Cruciate Retaining Total Knee Arthroplasty: An In Vivo Kinematics Study Using Mobile Fluoroscopy, The Journal of Arthroplasty (2016)

iTotal CR: More Natural Motion vs. Off-the-Shelf Implants

Abnormal

lift-offIncreased

load & wear

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Clinical Results: Range of Motion

ConforMIS

iTotal CROff-the-shelf p-value

ROM ≥ 120 degrees (%) 84% 45% 0.003

ROM < 100 degrees (%) 0% 14% 0.046

Source: Richard G. Buch, M.D., Robert W. Eberle, Jason Davis, M.D., and Rylie Buch, MS. Does Implant Design Affect Hospital Metrics and Patents Outcomes? TKA Utilizing a “Fast-Track” Protocol

• Overall ROM significantly higher among ConforMIS patients (p<0.001)

Patient Reported Outcomes – average of 16 Months Follow-up (“Fast-Track” Protocol)

62 patients (32 iTotal CR, 30 off-the-shelf), comparable age, sex, BMI

© 2017 ConforMIS, Inc. 21

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74.2 73.7

94.3

83.0

50.0

60.0

70.0

80.0

90.0

100.0

Off-the-Shelf

ConforMISiTotal

Patient Satisfactionp = 0.04

Knee Injury and Osteoarthritis

Outcomes Scorep = 0.037

© 2017 ConforMIS, Inc.

iTotal CR: Patient Satisfaction

Patient Reported Outcomes – 1 Year Follow-up

70 patients (35 iTotal CR, 35 off-the-shelf), matched pair analysis (age, sex, deformity)

Source: Katthagen et al; International Congress for Joint Reconstruction WAC 2015

%

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iTotal CR: Clinical Benefits

• Bone Preserving Design

• Less Ligament Releases

• Natural Motion of the Knee

• Higher Range of Motion

• Higher Patient Satisfaction

© 2017 ConforMIS, Inc. 23

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1 Katthagen et al; International Congress for Joint Reconstruction WAC 20152 Mont. J of Knee Surgery 2012. Single Use Instrumentation, Cutting Blocks and Trials Decrease Contamination during TKA

Surgery time

15 minutes less1

Instrument trays

5 fewer trays2

Set-Up and Tear

Down Time

$$$$

Surgeon OR StaffOR Staff

© 2017 ConforMIS, Inc.

Potential OR Cost Savings vs. Off-the-Shelf TKA

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© 2017 ConforMIS, Inc.

1.6

2.7

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Ave length of stay

Conformis iTotal

Off-The -Shelf

Source: Richard G. Buch, M.D., Robert W. Eberle, Jason Davis, M.D., and Rylie Buch, MS. Does Implant Design Affect Hospital Metrics and Patents Outcomes? TKA Utilizing a “Fast-Track” Protocol;

Days

p=0.004

62 patients (32 iTotal CR, 30 OTS), comparable age, sex, BMI (“Fast-Track” Protocol)

Clinical Results: Hospital Discharge Comparison

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© 2017 ConforMIS, Inc.

66%

97%

30%

80%

0%

20%

40%

60%

80%

100%

120%

<24 Hrs Discharged to home

ConformisiTotal

Off-The -Shelf

Source: Richard G. Buch, M.D., Robert W. Eberle, Jason Davis, M.D., and Rylie Buch, MS. Does Implant Design Affect Hospital Metrics and Patents Outcomes? TKA Utilizing a “Fast-Track” Protocol;

p=0.006

62 patients (32 iTotal CR, 30 OTS), comparable age, sex, BMI (“Fast-Track” Protocol)

p=0.049

Clinical Results: Hospital Discharge Comparison

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© 2017 ConforMIS, Inc.

iTotal CR: Potential for Economic Savings

A - attributed to a shorter length

of stay by 1.1 days.1

B - attributed to fewer patients

discharged to rehab (skilled

nursing facility).2

C - excludes OR savings

$1,100 $1,100

$2,200

$0

$500

$1,000

$1,500

$2,000

$2,500

A. Hospital StaySavings

B. DischargeDisposition Savings

C. Potential TotalSavings

© 2017 ConforMIS, Inc. 27

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30%

12%14%

16%18%

42%

2% 3%5%

8%

0%

10%

20%

30%

40%

50%

<3 LOS* Transfusion* Adverse Events(at discharge)*

Rehab/Post-DischargeAcute Care Facilities*

Adverse Events(90 day)*

Off-the-Shelf

ConforMIS iTotal

>$900 total cost of care savings to payer1

1 Culler et al; Comparison of Adverse Event Rates and Hospital Costs between Customized Individually Made Implants and Standard Off-the-Shelf Implants for Total Knee Arthroplasty. Submitted for publication. 2 Culler et al; International Congress for Joint Reconstruction WAC 2015.

iTotal CR: Clinical and Economic Benefits

248 patients (126 iTotal, 122 off-the-shelf)

* Indicates Statistical Significance1,2

© 2017 ConforMIS, Inc. 28

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Economic Benefits Summary

• Hospital and Payer Savings

– OR time

– Reusable instrument sterilization costs

– Length of stay

– Adverse events

– Discharge to home vs post acute care facilities

– Rehab cost

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PS55.8%

CR22.0%

PKR5.6%

Revision & other16.6%

PS55.8%

CR22.0%

PKR5.6%

Revision & other16.6%

Knee Replacement Market, US, by Revenue, 20132

● Cruciate-Retaining (CR) and Partial Knee Replacements (PKR)

● Posterior-Stabilized (PS) full launch in Q1 2016

PS launch nearly triples ConforMIS addressable market from ~ 28% to ~ 83% of knee market

1 Orthopaedic Industry Annual Report 20142 iData Research US Market for Large Bone and Joint Orthopedic Devices 2014

© 2017 ConforMIS, Inc.

Market Expansion: $7.5B Knee Replacement1

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Targeted Regional Commercial Strategy

Targeted Regional Commercial Strategy

Market Adoption

● Target local markets with goal of achieving more

than 10% market share

● Select based on

Procedure / surgeon density

ASP

CJR

● Focus on high-volume influential surgeons

● Marketing strategy to increase consumer awareness

Source: Based on ConforMIS estimates© 2017 ConforMIS, Inc.

0% 5% 10% 15% 20% 25% 30% 35%

Provo-Orem, UT

Medford, OR

Cedar Rapids, IA

Miami-Fort Lauderdale-West Palm Beach, FL

Port St. Lucie, FL

Huntington-Ashland, WV-KY-OH

Casper, WY

Nashville-Davidson--Murfreesboro--…

Boston-Cambridge-Newton, MA-NH

Albany-Schenectady-Troy, NY

Battle Creek, MI

Boulder, CO

Las Vegas-Henderson-Paradise, NV

Dayton, OH

Gainesville, GA

Mobile, AL

Colorado Springs, CO

Naples-Immokalee-Marco Island, FL

Canton-Massillon, OH

Riverside-San Bernardino-Ontario, CA

Bay City, MI

Lewiston-Auburn, ME

New Haven-Milford, CT

Macon, GA

Dallas-Fort Worth-Arlington, TX

Fort Wayne, IN

● 2014: ≥10% market share in 12 US MSAs

● 2015: ≥10% market share in 22 US MSAs

● 2016: ≥10% market share in 26 US MSAs

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1. Track My Implant – Patient Engagement 2. Live-Patient Education Department

3. Patient Ambassador Program 4. Viral Marketing

• Provide personal customer experience for each qualified inquiry

• Educate on ConforMIS vs “off-the-shelf”

• Provide surgeon names from locator• Provide second opinion resource

• Builds customer intelligence and market research

• Creates quality surgical leads

• Prescribed patient “opt-in” at office

• Six points of engagement featuring each stage of manufacturing process

• Keeps patient engaged with surgeons office and drives surgeon pre-op protocol

• No cost for enrollment

DTC - Empowering the Patient to Drive Adoption

• Real ConforMIS Patients

• Ambassadors are the center of our new “real patients” ad campaign

• Speak to other patients considering ConforMIS

• New website www.thisismyknee.com

• Cornerstone of our consumer facing brand

• Consumer Facing Brand - easy to remember

• Encourage patient participation

• Establishes emotional connection to brand

• Encourages Social media sharing

• Conversation Starter – Fun and Relatable

• Fills pipeline for future ambassadors and media stories

© 2017 ConforMIS, Inc. 32

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2. Regional MicrositesGoogle paid search; drives new patients into office

3. Regional Patient Seminars 4. Regional Advertising

1. Regional News Media - Traditional

© 2017 ConforMIS, Inc.

Co-Marketing - Empowering the Patient to Drive Adoption

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© 2017 ConforMIS, Inc.

Ambulatory Surgery Center (Outpatient)

• Opportunity• Outpatient procedures expected to grow in near term

• Driven by economics, surgeon reimbursement, advanced technologies

• Reimbursement - Medicare considering, private allowing selectively

• ConforMIS Value Proposition• Single-use, pre-sterilized kit

• No implant inventory (limited space)

• Only one reusable instrument tray (limited sterilization capacity)

• Simplified procedure, setup and turnover

• Fewer adverse events, transfusions and release to post-acute care

• More patients released within 24 hours

• ConforMIS Investing to Win in ASC• Outpatient program developed based on surgeon education

• Hiring dedicated ASC sales position to sell value proposition

• Differentiation messaging versus Off the Shelf 34

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ConforMIS IP & Financials

© 2017 ConforMIS, Inc. 35

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Patient-Specific Instruments (PSI)

Core patents expected to expire

2022 – 2031

Customized Orthopedic Implants

Core patents expected to expire

2022 – 2030

~450 patents and pending patent

applications owned or exclusively licensed

IP covers all joints and spine

© 2017 ConforMIS, Inc.

License agreements executed April 2015

• Use of patient-specific instruments; not customized

implants

• Wright lump-sum payment

• MicroPort lump-sum payment plus ongoing royalties

• High single digit to low double digit on PSI &

associated implant sales

Wright Medical and MicroPort

Lawsuit filed February 2016

• Alleges that Smith & Nephew‘s Visionaire® patient-

specific instrumentation and associated implants

infringes multiple CFMS patents

Smith & Nephew

Broad IP Portfolio

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Product Revenue Growth

Product Revenue

$24.6

$34.6

$48.2

$62.8

$78.9

$20.0 $20.4

$0.0

$10.0

$20.0

$30.0

$40.0

$50.0

$60.0

$70.0

$80.0

$90.0

2012 2013 2014 2015 2016 YTD'16 YTD'17

Mill

ions

© 2017 ConforMIS, Inc.

39%

30%

26%

Represents YoY Growth

Annual YTD

Key Drivers

● Leverage clinical and economic benefits

● Sales force expansion

● Targeted regional commercial strategy

● Growth of iTotal CR, iUni, iDuo

● Full launch of iTotal PS

2017 Guidance

● Total revenue $80M to $84M

● Product revenue $79M to $83M / CC growth 1-6%

● Underlying CC growth 10-15% adjusted for recall

delayed surgeries and change in Germany partial

knee reimbursement

● Royalty revenue $0.8M

● Gross Margin 36% to 38%

40%

2%

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Product Gross Margin Growth

Product Gross Profit / Margin

Mill

ion

s

0

5

10

15

20

25

30

2012 2013 2014 2015 2016 YTD'16 YTD'17

17%

28%

32% 32%

Represents product gross margin %

© 2017 ConforMIS, Inc.

Annual YTD

33%

Key Drivers

● Reduce material cost

Progressive vertical integration

3D printing, CNC machining

Vendor pricing - Increase volume

● Reduce labor cost

Design time reduction with progressive

software releases

Leverage lower labor cost OUS

● Overhead absorption - Increase volume7%

33%

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Summary

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© 2017 ConforMIS, Inc.

Long Range Goals

• Product Revenue

• Underlying Growth

• Gross Margin

• $79M - $83M

• 10% - 15% CC

• 36% - 38%

• Consistent Revenue Growth

• Expansion of Gross Margin

• Path to Profitability

2017 Guidance Long Range Goals

Improved Commercial Execution

Focused Operations

Platform Expansion

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Compelling Investment Thesis

Proprietary platform technology for customized joint replacement implants

~ $15B joint replacement market

Superior clinical

outcomes

Broad IP portfolio Highly scalable

business model

Economic benefits

© 2017 ConforMIS, Inc. 41

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Thank you