ORTHOCELL LIMITED — Investor Presentation 2015

Mar 16, 2015

Advancing Tissue Repair and Regeneration

Investor Presentation ASX: OCC

Paul Anderson Managing Director

Disclaimer

This presentation prepared by Orthocell Pty Ltd (" Company ") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issue or transfer of the securities referred to in this presentation in any jurisdiction in contravention of applicable law. Persons needing advice should consult their stockbroker, bank manager, solicitor, accountant or other independent financial advisor.

This document is confidential and has been made available in confidence. It may not be reproduced, disclosed to third parties or made public in any way or used for any purpose other than in connection with the proposed investment opportunity without the express written permission of the Company.

This presentation should not be relied upon as a representation of any matter that an advisor or potential investor should consider in evaluating the Company. The Company and its related bodies corporate or any of its directors, agents, officers or employees do not make any representation or warranty, express or implied, as to the accuracy or completeness of any information, statements or representations contained in this presentation, and they do not accept any liability whatsoever (including in negligence) for any information, representation or statement made in or omitted from this presentation.

This document contains certain forward looking statements which involve known and unknown risks, delays and uncertainties not under the Company’s control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward looking statements. The Company makes no representation or warranty, express or implied, as to or endorsement of the accuracy or completeness of any information, statements or representations contained in this presentation with respect to the Company.

It is acknowledged that the Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.

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Company Information

Orthocell is a world leading commercial stage regenerative medicine company

• Orthocell’s lead product, OrthoATI™ is a stem cell therapy to regenerate tendons and ligaments

ASX:	OCC
Share price	$0.36
Shares on issue	82,500,000
Market cap	$30 million
Options outstanding	5,912,500 (exercisable $0.50) 3,520,000 (exercisable @ $0.62)
Major shareholders	Stone Ridge Ventures 12.34% Paul Anderson 8.44% Ming Hao Zheng 8.56% Qi Xiao Zhou 7.22% Jia Xun Xu 6.26% Australian Super 5.60%

• Next product in late stage development is Celgro™ - a collagen scaffold for soft tissue reconstruction

3

Year highlights

• Increased number of patients treated with Ortho-ATI™ - now more than 270 patients treated with Ortho-ATI™

• First international sales of Ortho-ATI™ in Hong Kong

• Completed first human pilot trial of Celgro™

• Presented successful 4.5 year data on Ortho-ATI™ for Lateral Epicondylitis (tennis elbow) tendon repair

• Presented successful 2 year data on Ortho-ATI™ for Gluteal tendon repair

• Demonstrated first growth of tendon in a lab for future allogeneic tendon repair product

• Completed IPO raising $8MM in oversubscribed offering

• Secured collaboration with Bone Support AG for Celgro™ for bone void covering

Regenerative medicine market

Regenerative medicine is one of the fastest growing health markets driven by:

• an aging population

• increasing participation in sports activities

• growing trend of minimally invasive procedures

• advancement in orthopedic product technologies

U.S., EU and Japan Orthopedic Soft Tissue Repair Market Revenue by Procedure, 2013 –2020 (USD Million)

Ortho-ATI

Celgro

Procedures	2013	2014	2015	2016	2017	2018	2019	2020	CAGR (%)
Lateral Epicondylitis	734	758	783	807	832	856	879	903	2.9
Gluteal Tendon	52	52	52	53	53	53	54	54	0.4
Achilles	174	179	184	189	194	199	203	207	2.7
ACL	3,359	3,619	3,882	4,148	4,413	4,677	4,936	5,216	6.6
Rotator Cuff	1,823	1,951	2,070	2,185	2,296	2,401	2,499	2,588	5.0
Vaginal Prolapse	878	912	946	979	1,012	1,044	1,074	1,104	3.5
Total (USD MM)	7,020	7,472	7,918	8,362	8,800	9,229	9,645	10,072	5.2

Source: US Europe and Japan Orthopedic Soft Tissue Repair Market: Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 2020, Transparency Market Research 2015

Regen medicine corporate market heating up

Notable Deals 2013/14

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Source: Alliance for Regenerative Medicine Annual Report 2014

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Financings 2013/14

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Source: Alliance for Regenerative Medicine Annual Report 2014

Collagen Scaffold - CelGro™

• CelGro™ is a superior tissue regeneration technology that:

• has high mechanical strength and pliability

• has no foreign DNA and is pure

• is very cell friendly

• Multiple applications:

• tendon augmentation and repair

• bone repair and regeneration (dental and general)

• gynaecological and urological soft tissue repair

• general surgical soft tissue reconstruction

• ENT tympanic membrane and maxillofacial

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• Initial human trials in low risk applications are underway with pilot tympanic membrane (ruptured ear drum) study successfully completed and about to commence guided bone repair for dental application

• ARTG registration application planned for Q2 2015 with European CE Mark immediately thereafter

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Global Celgro™ market is significant

• Celgro™ is initially being developed for:

• Rotator Cuff repair - $1.8BB annual market with 45% revision rate for existing surgeries and no strong and resorbable scaffold available; and

• Vaginal Wall prolapse - $800MM annual market with NO scaffold products currently approved, following recent synthetic product withdrawals

• Regulatory approval for one indication allows broader use for general surgical and orthopaedic applications

• Significant M&A and licensing activity in the scaffold area for traditional surgical and newer cell therapy indications, including:

• 2014 – Organogenesis acquisition of Dermagraft for US $300MM

• 2013 – DSM buys Kensey Nash for US$360MM

• Orthocell plan to enter into multiple licenses for Celgro™ across different indications, as evidenced by recent Bone Support AB collaboration announcement in bone void repair

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Ortho-ATI™ - tendon regeneration

Proprietary method for expanding and cultivating tendon stem cells ( Tenocytes )

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TGA approved Minimally invasive
Tendon biopsy
GMP process to reinjection of
from patient to
expand and tenocyte cells at
collect tendon
cultivate site of tendon
stem cells
patient’s cells injury
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ATI = autologous tenocyte implantation

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Global Ortho-ATI™ market is significant

• Ortho-ATI™ has been applied to most tendon injuries, but regulatory approval in Australia is initially focused on:

• Lateral Epicondylitis - $700MM market largely dependent on surgery to address recalcitrant long term tendon damage;

• Gluteal tendon - $50MM market based on mechanical stabilization only, with NO effective regenerative treatment;

• Orthocell is currently generating revenue from treatments in Australia and New Zealand, with first patients in Hong Kong

• Initial Australian reimbursement application will be for Lateral Epicondylitis and Gluteal tendon

• Orthocell plan to continue data generation for further product registrations in a variety of tendon models throughout 2016/17

• Targeting international product registrations in Japan in 2016, then EU and USA

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Key Applications of Ortho-ATI™

Lateral Epicondylitis (Tennis Elbow)

• Ortho-ATI™ can structurally repaired tendon tissue in patients with severe tennis elbow

• Long term data (3-5yrs) demonstrates durability and effectiveness

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Key Applications of Ortho-ATI™

Gluteal Tendinopathy (Hip)

• Common injury in middle aged women with debilitating affect on quality of life and limited surgical success

• Ortho-ATI™ has demonstrated significant clinical improvement at 3 months, maintained to 24 months in treatment resistant patients

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10
VAS 8
Pain
(0-10) 6
4
2
p<0.001
0
Pre-treatment 3 months 6 months 12 months 24 months
Pre- and Post-injection Timeline
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Tendon in a lab – next generation

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Strain (%)
6
1 2 3 4 5 6 Time (s)
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Growing recognition

• Foster Stockbroking (23.09.2014)*

‘With two proprietary , mass market regenerative medicine treatments on the cusp of global commercialisation, we believe OCC is well positioned to transition into a significant player in the Biotech sector’

• Smart Investor, Trevor Hooey's top 10 picks (issued 21.11.2014)*

• ‘Orthocell has been quick to slip into gear after listing on the ASX in August’

“The field of regenerative medicine is reaching a point in its evolution where progress not only seen in headlines, but felt by thousands of patients who are receiving disease-altering therapies every day” Alliance for Regenerative Medicine Annual Report 2013

*Full copies of these research notes are available on the Company website www.orthocell.com.au

Upcoming Milestones 2015

• Commence CelGro™ guided bone repair trial – Q2 2015

• Commence CelGro™ Rotator Cuff clinical trial – Q2 2015

• Commence Ortho-ATI™ Lateral Epicondylitis trial – Q3 2015

• Ortho-ATI trial data Achilles – Q2 2015

• Finalise Bone Support AB collaboration – Q2 2015

• File CelGro™ registration application TGA – Q2 2015

• Secure international partner for Ortho-ATI™/ACI™ - Q4 2015

Investment Highlights

Approved treatments with strong clinical evidence

First tendon and ligament regeneration product approved in a major market

Significant unmet medical need

The market for musculoskeletal conditions in U.S. EU and Japan targeted by Orthocell therapies exceeds $7BB per annum

TGA approved manufacturing facility

Commercial manufacture ongoing in TGA approved cGMP facility

Next product in late stage development Global approvals and expansion underway Team with track record

Celgro™ planned for registration application in Q3 2015 Expansion of existing approvals to other international markets underway and first product licensed to China Team secured approval of Australia’s first cell therapy and Board has relevant M&A and licensing experience

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Advancing Tissue Repair and Regeneration

Thank you

ASX: OCC

Paul Anderson Managing Director