[April 30, 2015] |
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GI Dynamics, Inc.: Appendix 4C Quarterly Report Quarter Ended 31 March 2015
GI Dynamics, Inc. (ASX: GID) (GI Dynamics or the Company),
a medical device company developing innovative treatments for type 2
diabetes and obesity, is pleased to provide its financial results for
the quarter ended 31 March 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 15 May 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.
ENDO Trial
At the recommendation of the FDA, the Company has discontinued placing
any additional devices in its U.S. pivotal clinical trial of EndoBarrier
Therapy (the ENDO Trial); although monitoring and data collection
of the 325 currently enrolled subjects continues. The Company has
already implemented several risk mitigation strategies in the ENDO Trial
and is preparing to submit the information requested by the FDA for
their review.
Financial Review
The Company's key financial results for the Quarter include the
following:
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Revenue decreased to US$0.6 million for the Quarter compared to US$0.9
million for the same period last year, a decrease of US$0.3 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. Compared to the fourth quarter of 2014, revenue increased
US$0.1 million due to increased sales in Europe and the Middle East.
-
Cost of revenue for the Quarter and same period last year was US$0.9
million. The Quarter experienced decreased manufacturing efficiency
due to lower production volume compared to the same period last year.
As a result, gross loss increased by US$0.3 million for the Quarter.
-
Operating expenses decreased to US$9.6 million for the Quarter
compared to US$10.1 million for the same period last year, a decrease
of US$0.5 million.
-
Research and development expenses were US$5.6 million for the
Quarter compared to US$5.3 million for the same period last year,
an increase of US$0.3 million. The increase in research and
development expenses for the Quarter was primarily a result of
increased expenses to support the ENDO Trial and increased
consulting expenses. These were partially offset by a decrease in
personnel related costs.
-
Sales and marketing expenses were US$1.7 million for the Quarter
compared to US$2.5 million for the same period last year, a
decrease of US$0.8 million. The decrease in sales and marketing
expenses for the Quarter compared to the same period last year was
the result of lower spending on marketing related activities to
support the Company's commercialization effort as well as lower
personnel related costs, particularly share-based compensation.
-
General and administrative expenses were US$2.3 million for the
Quarter and the same period last year.
-
Other income (expense) for theQuarter was a US$0.5 million loss
compared to a gain of US$0.4 million for the same period last year, a
decrease of US$0.9 million. The decrease in the Quarter compared to
the same period last year was primarily associated with a US$0.5
million foreign exchange loss due to the depreciation of the
Australian dollar versus the U.S. dollar during the Quarter as
compared to a US$0.2 million foreign exchange gain in the same period
last year as a result of a stronger Australian dollar. Additionally,
in the first quarter of 2014 the Company had a US$0.2 million gain on
the remeasurement of the warrant liability while in the Quarter it had
a minimal loss on remeasurement.
-
As a result, the Company recorded a net loss of US$10.3 million for
the Quarter compared to US$9.7 million for the same period last year,
an increase of US$0.6 million.
-
The Company had cash and cash equivalents of US$40.0 million at 31
March 2015 compared to US$51.2 million at 31 December 2014, a decrease
of US$11.2 million.
****************CONFERENCE CALL & WEBCAST INFORMATION****************
GI Dynamics, Inc. (ASX: GID) will hold a conference call to discuss the
Company's financial results for the quarter ended 31 March 2015, and its
business outlook. Michael Dale, president and chief executive officer,
will host the call.
The briefing call to discuss financial results and business outlook will
be held at 6 p.m. U.S. EDT on Tuesday, 5 May 2015 (8 a.m. AEST on
Wednesday, 6 May 2015).
Accessing the Briefing 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/hccn2odi/lan/en.
Accessing the Briefing Call via Telephone:
For those preferring to listen by telephone, please dial in five minutes
prior to the start of the call and provide the passcode 39430802.
Regional dial-in numbers are as follows:
-
United States callers please dial toll-free 1 (888)
771-4371
-
Australia callers please dial toll-free 1 (800) 507-265
-
International callers please dial 1 (847) 585-4405
Replay archive:
The webcast will be archived for 30 days following the call on the GI
Dynamics website at investor.gidynamics.com.
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.
GI Dynamics is conducting a pivotal clinical trial of EndoBarrier in the
U.S. for the treatment of patients who have uncontrolled type 2 diabetes
and are obese. 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
possibility that 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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