GI Dynamics, Inc

http://gidynamics.com/ TICKER: GID     EXCHANGE: Australia

GI Dynamics, Inc. is a Boston US-based company focused on developing EndoBarrier.
EndoBarrier is a unique medical device that provides a minimally invasive, reversible treatment option for subjects with type 2 diabetes mellitus (T2DM) and obesity, who are unable to control their disease using standard treatments alone.

LATEST REPORTS

 
A pivotal year
Published: Apr 02 2019

GI Dynamics (GID) is preparing to commence a pivotal US clinical study for EndoBarrier, which remains to our knowledge the only implant targeted for treatment of type 2 diabetes mellitus (T2DM) plus obesity. GID would need to capture only a small share of a vast patient pool (up to 30m patients in the US alone) to achieve significant commercial potential. 
EndoBarrier is less invasive, less risky than gastric bypass surgery and combined with diabetes medication offers disease-modifying benefits. To date, the device has been implanted into c 4,000 patients with T2DM and/or obesity.
Efficacy is supported by data from extensive clinical studies including from the REVISE randomised controlled National Health Service (NHS) study. New NHS registry data indicate that 10-year cardiovascular risk was reduced following EndoBarrier treatment including a fall in risk of fatal stroke and coronary heart disease. Median insulin dose fell in patients concerned and 10/35 eliminated it altogether. In our view, the findings are highly supportive of the clinical and disease-modifying benefits of EndoBarrier in treating the major symptoms and co-morbidities of T2DM as well as promoting significant weight loss.
GID recently cleared one of the final hurdles prior to initiating the US study, having received IRB clearance to initiate Stage I. It has also attracted new expertise including industry veteran Stephen Linhares as VP of Clinical and Regulatory Affairs to help take GID forward through the next stage of its strategy. GID is preparing to launch the FDA trial with site selection expected to be announced imminently.
Our SOTP DCF valuation increases to $47.3m – updating for FY18 results and rolling forwards. This value includes $22.3m for US, $17.1m in CE Mark regions and $9.3m in India. A range of key events are anticipated in the next 6 – 12 months including CE Mark Certification, start of the IDE study and a trial for the India market in consort with partner Apollo Sugar: all suggesting that the current market capitalisation appears to present an attract opportunity to invest ahead of these potentially significant catalysts.
 
Unlocking the potential of EndoBarrier
Published: Dec 14 2018

GI Dynamics, Inc. ('GID') is a Boston US-based company focused on developing EndoBarrier.
EndoBarrier is a unique medical device that provides a minimally invasive, reversible treatment option for subjects with type 2 diabetes mellitus (T2DM) and obesity, who are unable to control their disease using standard treatments alone.
GID would need to capture only a small share of a vast patient pool (up to 30m patients in the US alone) to achieve significant commercial potential.  EndoBarrier is the only implant targeted for treatment of type 2 diabetes mellitus (T2DM) to our knowledge. It therefore has a clear opportunity to take the first mover position as a less invasive and less risky procedure compared to gastric bypass surgery combined with non-insulin medication. 
Data from extensive clinical studies including from the REVISE randomised controlled National Health Service study, showed disease-modifying outcomes in patients treated with EndoBarrier + standard medical therapy. 
Our near-term forecasts cover investment in development and assume that GID will need to raise a total $45m to fund its current strategy. We also acknowledge that the current leadership has put in place rigorous reporting processes in conjunction with the FDA to support the ongoing regulatory process helping rebuild trust in its execution. The rate of diagnosis at 1.5m new cases per annum in the US indicates that the population of T2DM sufferers could double by 2030 to exceed 40m.
Using a sum-of-the parts, risk adjusted DCF with a discount rate of 15%, our valuation of GID is $45.4m. This includes $16.7m for the US, $21.9m under CE Mark opportunities and $9m for India and assumes future refinancing. 

ARCHIVE

Foreign buyers gorging on UK stocks

Document can be downloaded here: UK plc ‘going for a song’

Being a shareholder in a company that receives a juicy takeover offer is a marvellous feeling. Something that many fortunate investors have experienced over the past 3 years. Thanks to a spate of M&A bids by deep pocketed overseas buyers – partly triggered by the June 2016 Brexit result, which sent the £ tumbling and adversely affected the FTSE.

Consequently today, given this trend is unlikely to end anytime soon, we’ve highlighted 30 possible acquisition ideas in the attached research paper. Spilt equally between large and smallcap stocks – covering a broad selection of industries.

What’s more we believe most of these businesses are underpinned by strong fundamentals and substantial upside in the event of predatory interest.

According to Factset Mergerstat/BVR, the average bid premium paid for such deals between 2004-14 was 30% – with the figure trending upwards since the global financial crisis.

Happy investing. Published 27th August 2019