LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. (ASX: GID), a company pioneering the development of effective, non-surgical approaches for treating type 2 diabetes and obesity, is pleased to provide its financial results for the year ended 31 December 2011. The Appendix 4E, which has been prepared in U.S. dollars, is attached; the results disclosed in the Appendix 4E are audited. Attached also find the audited consolidated financial statements for the years ended December 31, 2011, 2010 and 2009 with the Report of the Independent Registered Accounting Firm, Ernst & Young, LLP.
Business Highlights
Throughout 2011, the Company continued to advance its business and commercialization strategy for its lead product, the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), for the treatment of type 2 diabetes and/or obesity. During 2011, the Company’s major achievements were as follows:
- received first revenue from the sale of the EndoBarrier;
- established 13 Centers of Excellence in five countries including centers in Austria, Chile, Germany, the Netherlands and the United Kingdom;
- made important progress in existing EndoBarrier markets through the Company’s phased, commercial expansion, education and reimbursement initiatives such as those at the National Obesity Surgery Centre in Manchester, England and the Vitalys Obesitas Centrum, Rijnstate Hospital, Arnhem, Netherlands;
- completed a successful initial public offering on the Australian Securities Exchange (ASX) to fund the expansion of commercial roll-out efforts and a U.S. clinical trial;
- received approval from the Therapeutic Goods Administration (TGA) for the sale of the EndoBarrier in Australia;
- appointed Mark Twyman (formerly of Medimmune, Merck & Co. and Genzyme) as chief commercial officer, adding to the leadership team to advance the global commercialization of the EndoBarrier;
- completed enrollment for three clinical trials to expand the market for the EndoBarrier, including the treatment of lower BMI diabetic patients, re-implant of the EndoBarrier in patients previously implanted and a next generation anchor designed to be implanted for longer than 12 months; and
- expanded the Company’s presence at key medical meetings including the Annual Meeting of the European Association for the Study of Diabetes, the World Congress on Interventional Therapies for Type 2 Diabetes, Digestive Disease Week, and The Obesity Society annual meeting, highlighting data demonstrating the EndoBarrier’s ability to rapidly improve glycemic control and promote weight loss, as well as data showing the sustained benefits of the EndoBarrier on blood sugar control and weight loss for six months post-explant.
Financial Highlights
As set out in the attached Appendix 4E, the Company’s key financial results for the year were:
- raised approximately A$80 million in capital (A$74 million net of expenses of the offering) through a successful initial public offering on the ASX in September 2011;
- ended the year with a cash balance of approximately US$66 million;
- achieved revenues of approximately US$234,000 and recorded deferred revenue of approximately US$265,000, representing sales that could not yet be recognized as revenue according to accounting requirements under US GAAP;
- recorded a net loss of approximately US$26.4 million, including approximately US$8.6 million in research and development expenses reflecting ongoing clinical trials and continued product improvements; sales and marketing expenses of approximately US$5.0 million related to expanded commercialization efforts; and general and administrative expenses of approximately US$10.0 million with the largest expenses being patent litigation, patent prosecution and general legal costs; and
- recognized a foreign exchange loss of approximately US$3.3 million (of which US$1.2 million has been realized though the conversion of AUD to USD) due to depreciation of the Australian dollar since our IPO. Subsequent to the year-end, A$25.0 million was converted to USD at exchange rates from 1.05 to 1.08 with a realized foreign exchange gain of approximately US$1.4 million.
Commenting on the results, GI Dynamics’ President & CEO Stuart Randle said: “We are very pleased with the success we achieved in 2011 following our successful initial public offering. As we look ahead, we remain focused on achieving commercial growth for the EndoBarrier through additional Centers of Excellence and increased activity within existing Centers of Excellence.”
Looking Ahead to 2012
GI Dynamics’ strategy in 2012 is to focus on maximizing the success and market penetration at its Centers of Excellence in the U.K., Netherlands, Austria, Germany and Chile, while also commencing sales in a select number of new countries including Australia. A focus will be placed on receiving local reimbursement and collecting the data for national reimbursement.
In the United States, the Company is engaged in conversations with the U.S. Food & Drug Administration (FDA) to further define its U.S. clinical program. Following the conclusion of these conversations, the Company expects to begin a clinical study of the EndoBarrier in the U.S. later this year.
Upon the successful completion of additional clinical studies on the EndoBarrier, GI Dynamics’ plans to present or publish study results to expand the markets available to the EndoBarrier and support reimbursement purposes.
“We believe that these data, along with other ongoing studies, will provide the platform to expand the patient population that can benefit from the EndoBarrier,” Mr. Randle said. “Having established a solid commercial foundation in 2011 upon which to build, we are well positioned to continue to advance our sales and business objectives in 2012 and expect to have approximately 30 Centers of Excellence established by year-end.”
CONFERENCE CALL & WEBCAST INFORMATION
GI Dynamics will host a conference call and live audio webcast to discuss its full-year 2011 financial results, business activities and 2012 outlook, hosted by Stu Randle, Chief Executive Officer and Robert Crane, Chief Financial Officer.
Thursday, March 1, 2012 at 5 p.m. U.S. EST / Friday, March 2, 2012 at 9 a.m. AEDT
LIVE U.S. CALL-IN: 1-888-713-4211
LIVE AUSTRALIA
CALL-IN: 1800-729-868
LIVE INTERNATIONAL CALL-IN: +1-617-213-4864
PASSCODE
FOR CALL-IN NUMBERS: 86008212
THE WEBCAST CAN BE DIRECTLY
ACCESSED AT:
http://edge.media-server.com/m/p/msk8itpy/lan/en.
A REPLAY OF THE WEBCAST WILL BE AVAILABLE ON THE COMPANY’S WEBSITE FOR 30 DAYS FROM THE DATE OF THIS CALL:
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The company’s flagship product, the EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic patients and/or obese patients during the implant period. GI Dynamics currently markets the EndoBarrier in select regions in Europe and South America and is planning near-term commercial expansion into Australia and additional European countries. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.