GI Dynamics, Inc.: Appendix 4C: Quarter ended 30 June 2016

GI Dynamics, Inc. (ASX: GID) (the Company), a medical technology company that has developed an innovative device to improve outcomes for patients battling type 2 diabetes and obesity, today released its Appendix 4C — Quarterly Cash Flow Report for the quarter ending 30 June 2016 (the Quarter).

Highlights for the Quarter

• Release of further positive EndoBarrier clinical data, including:
  • Full U.S. ENDO trial results showing statistically significant 1.1% absolute reduction in HbA1c, a 13% reduction
  • UK NHS-sponsored ABCD data showing combination therapy of EndoBarrier plus Victoza® produced a 2.1% absolute reduction in HbA1c, a 22% reduction
  • Numerous clinical data presentations at Digestive Disease Week and American Diabetes Association meetings
• Improved cash flow and cash runway resulting from strategic cost-cutting and restructuring measures
• Appointment of Chairman Dan Moore
• Appointment of Chief Financial Officer Jim Murphy
• Appointment of Chief Compliance Officer and EVP Clinical Regulatory & Compliance Brian Callahan
• Response submitted on time to TGA; TGA has not yet replied to response

President & CEO Scott Schorer commented, “We have made significant progress in the restructuring and rebuilding of GI Dynamics over the past quarter. Many tough decisions needed to be made in order to preserve capital and stabilize the company. These actions will allow us to refocus efforts on developing optimal clinical, regulatory, and commercial strategies for EndoBarrier. We also continue to make progress towards rebuilding relationships with regulatory agencies in Europe and Australia and towards our goal of re-engaging with the FDA.”

Key Financial Information

Appendix 4C, which has been prepared in U.S. dollars under U.S. GAAP, is attached; the results disclosed in Appendix 4C are unaudited. The Company also plans to file its Quarterly Report on Form 10-Q with both the U.S. Securities and Exchange Commission and the Australian Securities Exchange by 10 August 2016. The Form 10-Q will provide financial statements for the Quarter, along with management’s discussion and analysis of financial condition and results of operations for the Quarter.

As of 30 June 2016, the Company had cash and cash equivalents of $12.3 million, compared to $15.6 million on 31 March 2016. The reduction in the cash and cash equivalents balance is due to net operating cash outflows of $3.4 million. Net operating cash outflows for the Quarter are primarily comprised of $1.8 million for staff costs, which includes approximately $0.6 million in one-time employee departure costs, $1.0 million for other working capital, $0.6 million for research and development costs, and $0.2 million for sales and marketing costs. These were offset by $0.1 million in customer receipts.

Investor Call to Discuss Results and Update on Strategy, Data and Cash Flow

The Company will hold a conference call at 6:30 p.m. U.S. EDT on Wednesday, 10 August 2016 (8:30 a.m. AEST on Thursday, 11 August 2016) to discuss the Company’s business outlook and the financial information for the Quarter. Scott Schorer, president and CEO, will host the call.

The Company will address the following topics on the call:

• Update on cash runway
• The Company’s corporate strategy, including upcoming milestones
• Review of clinical data

Accessing the Conference Call via Webcast:
A live webcast of the call will be available on the GI Dynamics website at investor.gidynamics.com. The webcast can be directly accessed at http://edge.media-server.com/m/p/px46rtrm/lan/en.

Accessing the Conference Call via Telephone:
For those preferring to listen by telephone, please dial in five minutes prior to the start of the call and enter the passcode 56384973.

Dial-in numbers are as follows:

• United States callers please dial toll-free 1 877 797 0688
• Australia callers please dial toll-free 1 800 005 989
• International callers please dial 1 615 247 0187

The webcast will be archived for 30 days following the call on the GI Dynamics website at www.investor.gidynamics.com.

About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier®, the first endoscopically delivered device approved for the treatment of type 2 diabetes and obesity. EndoBarrier is approved and commercially available in multiple countries outside the U.S. EndoBarrier is not approved for sale in the U.S. 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 www.gidynamics.com.

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160728006398/en/