GI Dynamics, Inc.: Appendix 4C Quarterly Report Quarter Ended 30 September 2015

Friday, October 30, 2015

LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)-- GI Dynamics, Inc. (ASX: GID) (GI Dynamics or the Company), a medical device company developing innovative treatments for type 2 diabetes and obesity, today announced its financial results for the quarter ended 30 September 2015 (Quarter). The Appendix 4C, which has been prepared in U.S. dollars under U.S. GAAP, is attached and the results disclosed in the Appendix 4C are unaudited.

The Company plans to file its Quarterly Report on Form 10-Q (Form 10-Q) with the U.S. Securities and Exchange Commission and with the Australian Securities Exchange on or before 14 November 2015. 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 and the year-to-date.

“Following our third-quarter decision to conclude the ENDO Trial, we have proceeded with our prior guidance to reorganize the business to allow time and resources to commence a review of the Company’s strategic options. We are well along in this process and continue to make progress. Specific to the ENDO Trial, as of October 23rd, we have completed all device removals from ENDO Trial subjects, well ahead of the originally projected timeline. Required post-explant patient follow-up is ongoing and we continue to make good progress toward clinical investigator site closures, final data monitoring and analysis and preparation for future scientific publication. Based on the ongoing review of ENDO Trial preliminary results, we remain confident that the final data report will demonstrate a statistically significant benefit of EndoBarrier Therapy that exceeds the predefined trial efficacy endpoint as measured by a reduction of circulating HbA1c levels. A scientific publication of the final ENDO Trial results is expected sometime in 2016. We remain steadfast in our belief that EndoBarrier Therapy is a valued treatment option for patients suffering from type 2 diabetes and obesity and look forward to pursuing the best path forward for achieving this aim for stakeholders,” said Michael D. Dale, president and CEO of GI Dynamics.

The Company believes its current cash balances will be sufficient to meet its anticipated cash requirements to fund operations through December 2016.

Financial Review

The Company’s key financial results for the Quarter and nine months ended 30 September 2015 include the following:

  • Revenue decreased to US$0.2 million for the Quarter compared to US$0.6 million for the same period last year, a decrease of US$0.4 million. Revenue decreased to US$1.1 million for the nine months ended 30 September 2015 compared to US$2.4 million for the same period last year, a decrease of US$1.3 million. The decrease in the Company’s revenue in the Quarter compared to the same period last year was a result of a decrease in sales across all markets except the Middle East. This decrease was a result of the regulatory related questions arising out of the termination of the ENDO Trial. Additionally, as part of the Company’s reorganization efforts in the Quarter, it decided to focus sales activity on a limited number of countries while disengaging from others. The decrease in the Company’s revenue in the nine months ended 30 September 2015 compared to the same period last year was a result of a decrease in sales across all markets primarily as a result of the ENDO Trial enrollment hold in the first quarter of 2015 and subsequent termination of the ENDO Trial.
  • Cost of revenue for the Quarter was US$0.9 million compared to US$0.4 million in the same period last year, an increase of US$0.5 million. Cost of revenue for the nine months ended 30 September 2015 was US$3.8 million compared to US$1.8 million for the same period last year, an increase of US$2.0 million. The primary reason for the increase in cost of revenue for the Quarter was decreased manufacturing efficiency due to lower production volume compared to the same period last year. The primary reasons for the increase in cost of revenue for the nine-month period was the charge of US$1.4 million recorded in the second quarter for sleeve inventory in excess of the Company’s currently anticipated commercial requirements and decreased manufacturing efficiency due to lower production volume. As a result, gross loss increased by US$1.0 million for the Quarter and US$3.2 million for the nine-month period.
  • Operating expenses decreased to US$7.2 million for the Quarter compared to US$11.9 million for the same period last year, a decrease of US$4.7 million. Operating expenses decreased to US$25.3 million for the nine-month period compared to US$34.9 million for the same period last year, a decrease of US$9.6 million.
    • Research and development expenses were US$3.9 million for the Quarter compared to US$6.8 million for the same period last year, a decrease of US$2.9 million. Research and development expenses were US$14.1 million for the nine months ended 30 September 2015 compared to US$19.7 million, a decrease of US$5.6 million. The decrease in research and development expenses for the Quarter and nine-month period was primarily a result of decreased expenses to support the ENDO Trial as a result of the enrollment hold and the ENDO Trial’s subsequent termination and decreased personnel related expenses.
    • Sales and marketing expenses were US$1.3 million for the Quarter compared to US$2.4 million for the same period last year, a decrease of US$1.1 million. Sales and marketing expenses were US$4.4 million for the nine-month period compared to US$8.0 million for the same period last year, a decrease of US$3.6 million. The decrease in sales and marketing expenses for the Quarter and nine-month periods compared to the same periods last year were the result of lower personnel related expenses, including stock-based compensation expense, and spending on marketing related activities.
    • General and administrative expenses were US$2.0 million for the Quarter and US$2.7 million for the same period last year, a decrease of US$0.7 million. General and administrative expenses were US$6.8 million for the nine months ended 30 September 2015 and US$7.3 million for the same period last year, a decrease of US$0.5 million. The decrease in general and administrative expenses for the Quarter and nine-month period was primarily due to a decrease in personnel related expenses.
  • Other income (expense) for the Quarter was a loss of US$0.2 million compared to a loss of US$0.4 million for the same period last year, a decrease of US$0.2 million. Other income (expense) for the nine months ended 30 September 2015 was a loss of US$0.6 million compared to income of US$0.4 million for the same period last year, a decrease of US$1.0 million. The decrease in the Quarter compared to the same period last year was primarily associated with a decrease in foreign exchange loss of US$0.3 million. The decrease in the nine-month period was primarily associated with an increase in foreign exchange loss of US$0.6 million due to the depreciation of the Australian dollar versus the U.S. dollar and a decrease in the gain on re-measurement of the warrant liability of US$0.3 million.
  • As a result, the Company recorded a net loss of US$8.1 million for the Quarter compared to US$12.1 million for the same period last year, a decrease of US$4.0 million. For the nine months ended 30 September 2015, the Company’s net loss was US$28.7 million compared to US$34.1 million for the same period last year, a decrease of US$5.4 million.
  • The Company had cash and cash equivalents of US$24.4 million at 30 September 2015 compared to US$51.2 million at 31 December 2014, a decrease of US$26.8 million, and US$32.8 million at 30 June 2015, a decrease of US$8.4 million.

Robert Solomon
Vice President of Finance & Company Secretary

About GI Dynamics

GI Dynamics, Inc. (ASX:GID) is the developer of EndoBarrier®, the first endoscopically-delivered device therapy approved for the treatment of obese type 2 diabetes with BMI ≥ 30 kg/m2, or obese patients with BMI ≥ 30 kg/m2 with ≥ 1 comorbidities, or obese patients with BMI >35 kg/m2. The liner is indicated for a maximum implant duration of 12 months. 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 centres 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.

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