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Transenterix announces 1st US sale

Nov 13, 2017 14
November 13th. Transenterix Inc…

We no longer recommend Array Biopharma Inc

Nov 11, 2017 10
November 11th 2017. We are withdrawing…

April 19th 2017 Short term investments recommendation - Commercial Vehicle Group, Inc.

Commercial Vehicle Group, Inc. is a supplier of a range of cab-related products and systems.

The Company operates through two segments: the Global Truck and Bus Segment (GTB Segment) and

the Global Construction and Agriculture Segment (GCA Segment). 


On April 19th - the day we published the recommendation - the stock could be bought at 7.7$ per share.

On April 21th - the stock could be sold at 8.5$ per share


Investors profit 10.38% 


The recommendation is no longer valid.  See our new recommendation next week.

Long term investments recommendation - Sophiris Bio

Sophiris Bio (NASDAQ.SPHS)  is a Canada-based biopharmaceutical company focused on the research, development and commercialization of products for the treatment of urological diseases.

We began our coverage of the company on December 14th 2016.  The stock was trading at $2.9 at the moment of our recommendation start.

The company lead drug in development is PRX302 (topsalysin).  With the drug Sophiris Bio has successfully passed Phase 2а of the study in prostate cancer. Despite that the study primary endpoint was only safety of the drug - it showed the drug ability to destroy tumor cells for at least 6 months (monitoring period in the study) in 11 of 18 total participants.  The drug showed good tolerability during the study


Now the company needs to do a Phase 2b trial to determine optimal dosage of the drug.  The Phase 2a was completed in June 2016. In August 2016 the company did a secondary offering and raised $30M which is enough to fund the Phase2b study.  The study has been initiated in Q1 2017.  The resusts are dure to be published in Q1 2018.

Also Sophiris Bio has successfully completed Phase 3 study in benign prostatic hyperplasia.  The company announced that a second Phase 3 study is required before submission to the FDA for Topsalysin marketing approval in the indication.  The second Phase 3 estimated cost announced by Sophiris is $53M.  The company announced that it will initiate the study only after a partnership or other options are concluded with a large biopharma to fund the Phase 3.


Long Term investment recommendation - TransEnterix Inc

TransEnterix, Inc. (NASDAQ:TRXC)  is a medical device company.

We began our coverage of the company on August 22nd 2016. At the moment we began our coverage the stock was worth $1.4 per share. Currently the stock is worth $3 per share.


The Company is focused on the development and commercialization of Senhance Surgical Robotic System, and SurgiBot System. The Company's Senhance System is a multi-port robotic surgery system, which allows multiple robotic arms to control instruments and a camera. The system features advanced technology to enable surgeons with haptic feedback and the ability to move the camera through eye movement. The system replicates laparoscopic motion and integrates three-dimensional high definition (3DHD) vision technology. The Senhance System also offers responsible economics to hospitals by offering robotic technology with reusable instruments.  .

Transenterix has developed the SurgiBot system and submitted it to the FDA for approval in late 2015.  Although the FDA rejected the application with the conclusion that the SurgiBot was "not substantially equivalent"  existing robotic systems.

After that Transenterix decided to focus all effors on sales of the Senhance system which it has acquired from SOFAR - a small Italian pharma that initially held the Senhance patents but had no money to commercialize it.  Senhance has the CE mark - the European approval for marketing and sales of the system in 28 European countries.  Transenterix began marketing Senhance from January 2016 and in early August announced the first sale in Milan, Italy.

Along with that Transenterix submitted Senhance to the FDA for approval in April 2017. On October 14th the company announced FDA approved the Senhance robot for commercial sales in the U.S.  And after that Transenterix plans to resubmit the Surgibot again.

The situation on the market is the following - there has been just one vendor of robotic surgical systems in the world - Intuitive Surgical Inc.  It has been enjoying the monopoly on the market since early 2000s till 2016.  Intuitive has placed over 3 500 systems (named Da Vinci) worldwide, most of them in the U.S. 

Although there is more than enough room left for others - in the U.S. robotic surgery holds just 5% of the total surgical industry, in Europe - 1%.  And Europe is the biggest market by number of hospitals.  

Considering that many experts say that Senhance is technologically more advanced that Intuitive Da Vinci, we believe that Transenterix is able to win its market share in the U.S, Europe, Middle East, Asia, Australia.  

Long term investment recommendation - Array Biopharma

Array BioPharma Inc. (NASDAQ:ARRY) is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer, hepatitis C


Recommendation is no longer valid


We began our coverage of the company on August 21th 2016. At the moment we started coverage of the company the stock was worth $3.5. Currently the stock is worth around $12.5 per share. INVESTORS PROFIT 257%

The company pipeline consists of 17 ongoing programs:  1-NDA pending , 4 - Phase 3 stage, 9- Phase 2 stage, 4- Phase 1 stage.

The company wholly owns global or key markets (incl the U.S.) rights for 6 of its drugs.  

12 Array invented drugs are licensed by Array to a number of global pharmaceutical companies for future sales.  All research and development costs related to those programs are financed by those companies.  The collaborators names include Novartis, Roche Holding, Astra Zeneca, Pierre Fabre, Merck, Celgene, El Lilly.

Array flagship program is development of the drugs named Binimetinib and Encorafenib  for melanoma treatment.  


COLUMBUS - trial of the combination of binimetinib + encorafenib to treat another melanoma type - BRAF mutant melanoma.  On September 26th 2016 Array Biopharma announced that its COLUMBUS Phase 3 study ended successfully. 

Array Biopharma submitted the application to the FDA  on July 5th 2017

If COLUMBUS program receives the FDA approval (and its highly likely now given the actual outcome figures) - Array Biopharma will cover the half whole market with treatments (BRAF type = 50% of patients).  The potential sales of the drugs could amount to $ 1,5 -$2  billion annually.

Another leading Array program is BEACON - treatment for colorectal cancer.  Array announced very encouraging Phase 2 results in June 2016.   Phase 3 began in July 2016 and it is co funded by Merck and Pierre Fabre.



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