Repligen Corp., although has had a modest run up, is not getting the respect it deserves. Volume is low, showing that not many know about this company.
Secreflo is a synthetic human secretin used with magnetic resonance imaging to improve pancreatic duct visualization for the detection of duct abnormalities to enhance clinical decision making in patients with known or suspected pancreatitis. Follow me? Maybe not. right? Here is the gist of it: Secreflo will prevent the need for painful and unnecessary procedures while showing a statistically significant improvement in sensitivity of detection of abnormalities of the pancreatic ducts.
The Phase 3 study demonstrated that all endpoints were met with statistical significance, and that Secreflo was safe and well tolerated.
- 1Q 2012 - Submit SecreFlo™ Marketing Authorization Application in Europe
- 1Q 2012 - Enroll first patient in RG2833 Friedreich's ataxia Phase I study in Italy
- 2Q 2012 - Interim data on SecreFlo™ pilot study to improve diagnosis of pancreatic cancer
- 2Q 2012 - Complete integration of Novozymes Biopharma AB
- 2Q 2012 - Report results of RG3039 Phase I study for Spinal Muscular Atrophy
- 2Q 2012 - Present SecreFlo™ Phase III data at Digestive Disease Week (DDW)
- June 21, 2012 - SecreFlo™ PDUFA date with priority review
- 2H 2012 - Launch SecreFlo™ in the US pending FDA approval
- 2H 2012 - Initiate pediatric studies of SecreFlo™
So, what is the potential here? Well, there are more than 300,000 MRI procedures conducted in the U.S. and Europe each year that could directly benefit by the addition of Secreflo. Eventually, it will get the acceptance in many other countries. At $600 per procedure, times a conservative 500,000 pancreatic MRI procedures annually, the company has the potential to bring in over $300 million in revenues, not including their projected 50 million in 2012 from other non-related projects.
There will be an Ad Com meeting on May 31 where the FDA will vote on their recommendation for approval. It should be a overwhelming vote of approval, based on data, followed by the PDUFA date June 21st.
At current prices, we have a market cap of $180 million. There is not another stock under $10 a share that has a priority review and an orphan drug designation out there.
Giving Repligen a market cap of $360 million (30 million O/S x 12.00/share), which is in line with the potential revenue of $350 million annually, Repligen could start to get the respect it deserves and command a price per share of $12.00 in the very near future. Don't be surprised.
Disclosure: I am long RGEN.