implite china january 2016

ImpLite Ltd., Israel

Ami Glicksman, MDCEO & Founder

First liquid and silicone-gel free breast implants

Disclaimer This Investor Presentation has been prepared by ImpLite Ltd., (“Company”) for investors, solely for informational purposes. The information contained herein has been prepared to assist prospective investors in making their own evaluation of the Company and does not purport to be all-inclusive or to contain all of the information a prospective or existing investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company and the data set forth in this information. ImpLite Ltd. makes no representation or warranty as to the accuracy or completeness of this information and shall not have any liability for any representations (expressed or implied) regarding information contained in, or for any omissions from, this information or any other written or oral communications transmitted to the recipient in the course of its evaluation of the Company. This Information includes certain statements and estimates provided by the Company with respect to the projected future performance of the Company. Such statements, estimates and projections reflect various assumptions by management concerning possible anticipated results, which assumptions may or may not be correct. No representations are made as to the accuracy of such statements, estimates or projections. Prospective investors will be expected to have conducted their own due diligence investigation regarding these and all other matters pertinent to investment in the Company. This presentation may contain statements that are not historical facts, referred to as “forward looking statements.” The corporation’s actual future results may differ materially from those suggested by such statements, depending on various factors.

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Breast surgery with implants has not been innovated for 40 years and surgeons cannot provide the best solutions:a. Project a ptotic (sagging) breast

without augmenting it;b. Implant a super-safe, super-light

and long-lasting implant for augmented breasts;

c. Reconstruct lumpectomy defects with an implants.

All rights reserved to ImpLite Ltd. 3

The problems we see in patients:

Post lumpectomy defects

Deflated saline implant – left breast

Breast ptosis due to heavy gel implants. See elbow level nipple position as indicator

a. ImpLite Ltd. was Incorporated in Israel 2008b. Intellectual property: 7 patent applications, with 2

patents approved in USAc. Ami Glicksman, MD - founder, previously President

of UltraShape Inc. led the company including R&D, clinical affairs, and multiple financing rounds.

d. Experienced leading team (finance, marketing, engineering, regulatory, legal, and silicone manufacturing)

e. Based on practical experience of a plastic surgeonf. Headquartered in Israel

Company overview



World implant markets year 2014*

Territory Value millions $ %

USA 445 45

EU 249 24

Asia Pacific 188 19

Latin America 132 12

Total 1,014 100%

Differences among markets are attributed to:a. Cultural differences related to appearanceb. Financial capabilities c. Availability of health services and insurance

coverage* Michael Moretti, Medical Insight, Inc. IMCAS February 2015


Competitive sales landscape 2014

Company % of market $ in millions

Allergan Inc., USA acquired by Pfizer Inc.

40 406

Mentor Worldwide, a J&J company - USA

39 400

GC Aesthetics – Ireland 6 60

Silimed – Brazil 5 50

Others (7-10) 10 98


Breast surgery market overview

* Augmentations - http://www.surgery.org/sites/default/files/Stats2013_4.pdf** Lifts with implants estimated as 50% of all - http://www.surgery.org/media/statistics - *** Lumpectomy recon. - estimated as 50% of annual incidence of breast cancer (1.7 million)

Procedure Market Cases/year

Augmentations WW 1,200,000

Lifts + implants USA 70,000

Implant recon. USA 84,000

Lumpectomies WW 1,700,000

Projection-only: new segment – currently no implant solutionLumpectomy reconstructions: about 500,000 cases a year are

candidates for the new implant surgery


Implant market overview 1997 - 2013

* http://www.surgery.org/media/statistics

ASAPS 1997-2013* Cases - USA WW cases # of Implants WW value

Augmentations 4,800,000 8,000,000 16,000,000 $12.8B

Lifts with implants 750,000 1,250,000 2,500,000 $2.0B

Total 5,550,000 9,250,000 18,500,000 $14.8B

- Market overview analysis is based on cumulative data published by the

ASAPS.

- Total Lifts are 1,500,000 cases; estimated that 50% are with implants.

- USA estimated to be 60% of WW market

- FREEDOM™ implant ASP - $800

Our figures in the table represent the existing market size and value for the Freedom™ implant by the company


Future annual world wide market opportunity

* These figures add up to existing breast implant past pool figure.

** Implant ASP – $800

*** Average surgeon’s fee USA for augmentation – $2,386 (ASAPS)

**** According to Q3/2014 Allergan’s earning call

- Surgeons are the biggest promoters of market!

- Year-to-date market growth is 3%****.

Our figures in the table represent the annual market size and potential value for the Freedom™ implant by the company

2014… YTD Cases # of Implants WW value Surgeons’ fee

Augmentations 1,200,000 2,400,000 $1,920,000,000 $2,863,200,000

Lifts plus recon. 154,000 308,000 $246,400,000 $367,444,000

Total 1,354,000 2,708,000 $2,166,400,000 $3,230,644,000


Then why ImpLite?

…Because we have invented three state-of-the-art new implants:

a. The MAGIC™ implant - The first projection-only implant with no augmentation of breast!

b. The FREEDOM™ implant – a. The first liquid and silicone-gel free implantb. the first ‘dry’ and super-light implant (1/3 in

weight).c. The ESSENTIAL™ implant - The first implant

suitable for immediate & delayed lumpectomy reconstruction and as a soft tissue filler all-over the human body.

a. ’Dry’ implant b. SAFE – silicone-gel & saline freec. Replaces older implantsd. Ultra-light – 70% less weight e. No implant related ptosisf. Long lasting aesthetic results


The FREEDOM™ implant

a. The first projection-only implant without augmentation of breast!

b. Can be used to correct breast ptosis with ample breast tissue and no additional volume increase

c. Weighs only 35 gramsd. Made of reinforced biocompatible silicone polymers


The MAGIC™ implant

a. The first implant suitable for immediate and delayed lumpectomy reconstruction

b. Different shapes and sizes to match any excisionc. Uncatered market of annual 1.7 million new cancer

casesd. Suitable also as soft tissue filler for soft tissue defects

in all body regions


The ESSENTIAL™ implant


ImpLite’s regulatory plan

Approach the US market first by obtaining FDA approval.Breast implants are regarded as class III devices, i.e. mandate clinical trials for approval to market. ImpLite had the first meeting and discussion with the FDA.Breast implants are PMA devices. For approval the proposed trial includes 155 patients (2:1 controls) and follow-up period of 1-2 years.FDA approval is regarded superior to CE mark in the markets. Note: Having FDA approval will give the company a higher market valuation!


Reimbursement vs. private

Breast implants are used for two different indications:a. Reconstruction – mostly reimbursed by HMO’s and

insurance plans.b. Aesthetic surgery – out of pocket money and no

reimbursement. Financing is common.

Implant reimbursement Out-of-pocket $

Freedom™ Yes: 10-15% Yes: 85-90%

Magic™ No Yes: 100%

Essential™ Yes: 95% Yes: 5%


Approach the market

a. Launch in USA as first territoryb. Sales:

a. Establish alliance with a strategic partner, OR b. Use existing sales networks and distributors

c. Post marketing clinical trials to provide evidence-based results supporting marketing

d. Promote implants in plastic surgery meetings and workshops with KOL’s support

e. Web based education to surgeons and physicians.f. Web based marketing & education to potential patients.


Working plan USA (FDA) to marketing & sales

Follow-up I* - assume 1 year follow-up for FREEDOM™ ImplantFollow-up II** - assume 2 year follow-up for FREEDOM™ Implant

Y1 Y2 Y3 Y4 Y5Process H1 H2 H3 H4 H5 H6 H7 H8 H9 H10Transfer to manufacturing Bench testing Reg. plan approval

Trial & sales scenariosFollow-up I*

FDA approval Marketing

Sales

Follow-up II**

FDA approval Marketing

Sales


Sales & gross profit projections

per implant Freedom Magic COGS $120 $35ASP $800 $800

Freedom Magic Cumulative gross margins

# of implant 30,000 40,000

COGS 3,600,000 1,400,000

Revenues 24,000,000 32,000,000

year 1(Y5) Gross margins 20,400,000 30,600,000 $51,000,000

# of implant 80,000 200,000

COGS 9,600,000 7,000,000

Revenues 64,000,000 160,000,000

year 2 Gross margins 54,400,000 153,000,000 $207,400,000

# of implant 160,000 400,000

COGS 19,200,000 14,000,000

Revenues 128,000,000 320,000,000

year 3 Gross margins 108,800,000 306,000,000 $414,800,000


Financing

a. ImpLite Ltd. is seeking $ 6-10 million in equity and loan facility.

b. The investment will place the company in a position to launch sales in the USA.

c. Manufacturing for sale can be funded by debt funding.

d. Additional funding for launching marketing and sales in the USA (first territory) will be needed in due time.

Use of proceeds 4 years


1,119,501

1,197,755

2,408,659

448,103

2,147,239

20,000 478,913

1,943,400

Total 4 years $

R&D ClinicalRegulatory ITEngineering & Production LogisticsReimbursement Sales and MarketingMG&A

$ % Regulatory 2,408,659 25%

Eng. & Production 2,147,239 22%

MG&A 1,943,400 20%

Clinical 1,197,755 12%

R&D 1,119,501 11%

Sales & marketing 478,913 5%

IT 448,103 5%

Logistics 20,000 0%

9,763,569 100%

P&L 5 years


Y1 Y2 Y3 Y4 Y5 Total

Income $ 56,000,000 $ 56,000,000

Cogs 3,239,697 3,239,697

Gross Profit 52,760,303 52,760,303

R&D 340,000 265,000 247,250 267,250 252,251 1,371,752

Clinical 74,000 332,639 390,558 400,558 390,558 1,588,312

Regulatory 748,000 790,500 377,000 493,159 482,317 2,890,976

Engineering & Production 720,648 452,197 142,197 832,197 - 2,147,239

Logistics 20,000 80,000 100,000

IT 7,500 131,488 154,558 154,558 169,558 617,661

Reimbursement - - - - 84,000 84,000

MG&A 430,200 434,400 461,400 617,400 717,400 2,660,800

Sales and Marketing - - - 478,913 7,754,913 8,233,826

EBIDTA $2,320,348 $ 2,406,224 $ 1,772,963 $ 3,264,034 $ 42,829,306 $ 33,065,737

Y5 – first year of sales


a. Board certified plastic surgeonb. Former director of burn unit, Sheba Medical Center,

Ramat Gan, Israelc. Founded UltraShape Ltd.; developed the first FDA

approved device for non invasive fat ablation by focused ultrasound; acquired by Syneron-Candela Ltd.

After

The inventor/founder: Ami Glicksman, MD

Before

Thank you!


Ami Glicksman, MD

CEO & Founder

Email: [email protected] Mobile: +972 54 240 2401www.implite.com

implite china january 2016

Health & Medicine