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1 GI Dynamics, Inc. ASX Announcement Corporate Presentation LEXINGTON, Mass & SYDNEY, Australia 12 May 2016 AEST GI Dynamics, Inc. (ASX: GID) (the Company), announces that the Company made a presentation today on the previously announced shareholder conference call. The Company presented a Q quarterly shareholder brief. The presentation materials delivered on the shareholder conference call are attached hereto. A copy of these presentation materials are also being filed with the U.S. Securities and Exchange Commission and being posted under the Investor Relations section of the Company s website at investor.gidynamics.com. About GI Dynamics GI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier, the first endoscopically delivered device therapy approved for the treatment of type 2 diabetes and obesity. EndoBarrier is approved and commercially available in multiple countries outside the United States. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit Forward-Looking Statements This announcement contains forward-looking statements concerning: our development and commercialization plans; our potential revenues and revenue growth, costs, excess inventory, profitability and financial performance; our ability to obtain reimbursement for our products; our clinical trials, and associated regulatory submissions and approvals; the number and location of commercial centers offering the EndoBarrier; and our intellectual property position. These forward-looking statements are based on the current estimates and expectations of future events by the management of GI Dynamics, Inc. as of the date of this announcement and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the consequences of terminating the ENDO Trial and the possibility that future clinical trials will not be successful or confirm earlier results; risks associated with obtaining funding from third parties; risks relating to the timing and costs of clinical trials, the timing of regulatory submissions, the timing, receipt and maintenance of regulatory approvals, the timing and amount of other expenses, and the timing and extent of third-party reimbursement; risks associated with commercial product sales, including product performance; competition; risks related to market acceptance of products; intellectual property risks; risks related to excess inventory; risks related to assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches, future financial results and other factors including those described in our filings with the U.S. Securities and Exchange Commission. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA T +1 (781) F +1 (781) EUROPEAN OFFICE: Prinzenallee 7, Dusseldorf, Germany T: AUSTRALIAN OFFICE: Level 8, Bridge Street, Sydney, NSW 2000 T GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN

2 GI Dynamics, Inc. ASX Announcement Page 2 Investor relations Investor Enquiries: Media relations Media Enquiries: United States: James Murphy Chief Financial Officer +1 (781) Australia: David Allen or John Granger Hawkesbury Partners Pty Limited United States/Europe/Australia: investor@gidynamics.com +1 (781) United States/Australia: Catie Corcoran WE Buchan +1 (813) US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA T +1 (781) F +1 (781) EUROPEAN OFFICE: Prinzenallee 7, Dusseldorf, Germany T: AUSTRALIAN OFFICE: Level 8, Bridge Street, Sydney, NSW 2000 T GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN

3 GI Dynamics, Inc. Q1 16 Quarterly Shareholder Brief 5/12/16

4 Forward-Looking Statements Currency References Financial amounts in this presentation are expressed in US Dollars, except where specifically noted. Forward-Looking Statements This presentation contains forward-looking statements concerning: our development and commercialization plans; our potential revenues and revenue growth, costs, excess inventory, profitability and financial performance; our ability to obtain reimbursement for our products; our clinical trials, and associated regulatory submissions and approvals; the number and location of commercial centers offering the EndoBarrier ; and our intellectual property position. These forward-looking statements are based on the current estimates and expectations of future events by the management of GI Dynamics, Inc. as of the date of this presentation and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the consequences of terminating the ENDO Trial and the possibility that future clinical trials will not be successful or confirm earlier results; risks associated with obtaining funding from third parties; risks relating to the timing and costs of clinical trials, the timing of regulatory submissions, the timing, receipt and maintenance of regulatory approvals, the timing and amount of other expenses, and the timing and extent of third-party reimbursement; risks associated with commercial product sales, including product performance; competition; risks related to market acceptance of products; intellectual property risks; risks related to excess inventory; risks related to assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches, future financial results and other factors including those described in our filings with the U.S. Securities and Exchange Commission. Given these uncertainties, you should not place undue reliance on these forwardlooking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. Disclaimer This presentation and any supplemental materials have been prepared by GI Dynamics, Inc. based on available information. The information contained in this presentation is an overview and does not contain all information necessary to make an investment decision. Although reasonable care has been taken to ensure the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness, or correctness of such information and opinions and no reliance should be placed on such information or opinions. To the maximum extent permitted by law, none of GI Dynamics, Inc., or any of its members, directors, officers, employees, or agents or advisors, nor any other person accepts any liability whatsoever for any loss, however arising, from the use of the presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability arising from fault or negligence on the part of GI Dynamics, Inc. or any of its directors, officers, employees or agents. 5/12/2016 GI Dynamics, Inc. 2

5 Conference Call Agenda Shareholder update Corporate priorities ENDO data Financial update ABCD data Additional clinical information 5/12/2016 GI Dynamics, Inc. 3

6 Scott Schorer: President & CEO Employment Senior consultant working with CEOs and Boards to resolve strategic, operational, finance issues Systagenix Wound Management: President Americas IST / Innovative Spinal Technologies: CEO CentriMed Global Healthcare Exchange: CEO US Army Infantry: 82 nd Airborne Division: Platoon Leader Experience Raised >$120m private equity, public equity, debt financings Multiple distressed company leadership roles Multiple product approvals & product launches 5/12/2016 GI Dynamics, Inc. 4

7 Corporate Priorities 1. Modify Cost Structure. We will implement a leaner, more efficient cost structure by cutting expenses to extend our cash runway. 2. Rebuild Team. I will appoint a new chief financial officer and chief compliance officer (responsible for clinical, regulatory, and quality), in addition to adding other experienced team members. 3. Develop Clinical Data and Core Science. We will continue to support investigator-initiated studies around the world along with internal analyses of the safety and efficacy of EndoBarrier Therapy. 4. Focus Revenue Efforts. We will focus on strategic commercial centers outside the United States. 5. Improve Regulatory Relationships. We will work with the FDA to review lessons learned from the ENDO Trial to design our next EndoBarrier Therapy trial, and collaborate with our European Notified Body and the TGA in Australia to refine systems and postmarket surveillance. In process / partially complete: Reduced staff 30%, restructuring expense across entire organization Initial phase complete: CFO Murphy, CCO Callahan, local quality and regulatory professionals In process: Multiple activities to understand root cause for hepatic abscess and means to mitigate risk; refining approach to new IDE protocol In process: Multiple activities to focus commercial activities, drive sales force effectiveness In process: New CCO Callahan initiating dialogue with all regulatory bodies & assessing legacy issues 5/12/2016 GI Dynamics, Inc. 5

8 ENDO Trial Efficacy Measure Primary Efficacy Endpoint: Mean Change in HbA1c from Baseline to 12 Months Top-Line Results 0.71% greater with EndoBarrier Therapy than with sham control (absolute HbA1c) Posterior Probability of Super-Superiority 92.8% (pre-specified criterion was > 96.5%) Additional ENDO Trial results will be shared publicly at the American Diabetes Association s 2016 Scientific Sessions in New Orleans, LA, for which an abstract with results from the trial has been accepted for poster presentation. As a condition of acceptance, an embargo on the release of data is in effect until that time. GI Dynamics is also working with the ENDO Trial Executive Committee on finalization of the ENDO Trial clinical study report ( CSR ), which will be submitted to the FDA. Finally, as part of our ongoing collaboration with our study investigators and consistent with mutually-agreed upon terms established at the beginning of the study, we are protecting our investigators ability to publish. GI Dynamics will release further data in June /12/2016 GI Dynamics, Inc. 6

9 ENDO Trial Safety Measure Primary Safety Endpoint: Device-Related SAEs Resulting in Early Device Removal Top-Line Results Occurred in 11.7% of subjects Posterior Probability 90.5% (pre-specified criterion was > 96.5%) Hepatic Abscess Occurred in 7 subjects, representing a rate of 3.5% (7/201) 5/12/2016 GI Dynamics, Inc. 7

10 Jim Murphy: CFO Employment International Accounting firm Arthur Andersen Boston office Life Sciences since 1990: Specialty Pharma, Biotech instrumentation and consumables, Drug development, Med device Predominantly public companies Experience > $350M in capital raised private & public Multiple stressed company situations Strong operational experience International M&A on buy & sell side 5/12/2016 GI Dynamics, Inc. 8

11 1Q 2016 Results US$000 s 1Q Q 2015 Revenue Operating Expenses 3,321 9,600 Net Loss (3,438) (10,349) 31 Mar Dec 2015 Cash on Hand 15,782 19,590 Unit volume drove decrease in revenue Stopping ENDO Trial and prior restructuring activities drove decrease in operating expenses 5/12/2016 GI Dynamics, Inc. 9

12 Brian Callahan: CCO and EVP Clinical, Regulatory, Quality Employment Founded EEC & Associates a global compliance-consulting firm for the Medical Device, Pharmaceutical, Biologics Industry: Vertex, Hologic, Johnson & Johnson, Fortress Investments, BMS, Schering Plough, Wyeth, Pliva, MDS Pharma, IST, BioCryst Pharmaceuticals Leadership: Histogenics, Prochon Biotech, Organogenesis, Quintiles R&D, engineering, technical services, compliance US Army nuclear weapons specialist Experience Involved in numerous compliance recovery projects Excellent working relationship with current and former FDA officials, MHRA, IMOH, PMDA, and ANVISA Strong Clinical (Preclinical, Phase I, II, and III), Regulatory (510Ks, PMA, BLA, ANDA and NDAs), and Quality experience (Over 40 FDA inspections) 5/12/2016 GI Dynamics, Inc. 10

13 Clinical, Regulatory, Quality Completing Endo Trial Clinical Study Report for FDA submission Updating Clinical Evidence Report for TGA Auditing quality systems Engaging with notified body, TGA and FDA 5/12/2016 GI Dynamics, Inc. 11

14 ABCD REVISE Diabesity Study A multi-center, randomized controlled trial initiated and funded by the Association of British Clinical Diabetologists (ABCD). Two-year study aims to evaluate the efficacy and legacy effect of treating obese type 2 diabetes patients with the EndoBarrier gastrointestinal liner combined with a GLP-1 receptor analog (liraglutide), compared to patients treated with either liraglutide alone or EndoBarrier Therapy alone. 5/12/2016 GI Dynamics, Inc. 12

15 ABCD REVISE Diabesity Study: One-year interim results EndoBarrier + liraglutide (N=24) EndoBarrier only (N=24) Liraglutide only (N=22) HbA1c (absolute raw values) Weight HbA1c mean baseline 9.6% 9.3% 9.7% HbA1c 12 mo. 2.1% 1.2% 1.3% 12 mo. 7.5% 8.1% 8.4% Subjects w/ < 7.5% 12 mo. 54.2% 45.8% 31.8% Weight (kg) mean baseline Weight loss (kg) Total % weight loss 11.3% 10.8% 3.5% Dosing Liraglutide/ mg daily 1.2 n/a 1.8 5/12/2016 GI Dynamics, Inc. 13

16 Clinical Information Releases Worldwide Registry, 10-3 German Registry Australian Registry (through ABCD Registry) GID Sponsored Registries, n = 2 Investigator Status N Multiple COMPLETE 240 Multiple Ongoing ~220 Multiple In Discussions n/a Primary Endpoint Observational (Safety and Efficacy) Observational GI Dynamics Clinical Information Release Schedule EndoBarrier Treatment in Obese Subjects with T2DM Measurement of postprandial plasma levels of GIP, GLP-1, insulin, C- peptide, glucagon and glucose before and after treatment with DJBS ABCD ENDO Trial Evaluation of CV Inflammation Biomarkers Effects and Mechanisms of Safety and Action of EndoBarrier effectiveness of in Obese T2DM treating morbidly Patients: Focus on obese adolescents Intraluminal with endoscopic DJBL Triglyceride Digestion and Microbiome (NASH) EndoBarrier Compared with Standard Medical Therapy in Obese subjects with T2DM Graz & Vienna Pilot EB vs. Bariatric Surgery Waitlist Country Israel Denmark UK United States Germany Slovenia Australia UK Austria Australia PI Lieberman Knop Ryder Kaplan Seufert Battelino Holtmann Teare Pieber/Sourij Frydenberg # implanted out of 216 randomized to device # controls NA NA 24 (Lira1.8mg) N/A 20 Design 1-arm non-randomized 2-arm non randomized Open label 3:1 RCT Implant Duration + Post Removal Multi-center, doubleblinded*, randomized *until trial was stopped early Case series, stored serum/plasma samples Open label 1:1 RCT RCT, DB, single center Open label 1:1 RCT Open label, single arm, multi-center, Pilot 2-arm, open label, case series weeks weeks weeks 52 weeks + 26 weeks 52 weeks+26 weeks weeks 52 weeks+52 weeks weeks 52 weeks+12 weeks 52 weeks+52 weeks Primary Endpoint Δ HbA1c gut hormones Δ HbA1c HbA1c with a 0.4% super-superiority margin over sham Δ in biomarkers from baseline BMI weight Proportion 20% HbA1c Δ insulin sensitivity, ß cell function Δ HbA1c Enrollment Status Estimated Date of Disclosure Complete Complete Complete Stopped Ongoing Enrolled: 100% Enrolling. 8 implanted. Enrolled: 40% In contracting Pending approval 5/12/2016 GI Dynamics, Inc ADA/EASD EASD Q16, additional TBD Q216 (ADA in June) Q216 Q Q18 TBD TBD

17 Thank you Investor relations Investor Inquiries: Media relations Media Inquiries: United States: James Murphy Chief Financial Officer +1 (781) Australia: David Allen or John Granger Hawkesbury Partners Pty Limited United States/Europe/Australia: investor@gidynamics.com +1 (781) United States/Australia: Catie Corcoran WE Buchan +1 (813) /12/2016 GI Dynamics, Inc. 15