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."
Spermidine regulates RIPK1 to combat diabetes and vascular damage