TrustThe biggest problem that we have right now is the trust in Microbix following through on growth and increasing share value and most of that is because of Lumisort and Kinlytec.
Fund managers that have promoted MBX based on the potential of Kinlytic are going to be hesitant to promote MBX unless they have several quarters of profitability to back up recommendations.
Hindsight is always 20/20 and it is easy to say that now. A lot was based on Kinlytic when MBX acquired it and it looked like it had huge potential, but the cost's required to get all the legalities (which took many years and a lot of resources) was an exceptionally large hit to the bottom line. And continue to have annual costs, keeping MBX from being profitable beyond operating expenses.
Do not get me wrong, I think that Kinlytic is a great product with exceptionally good potential for improving the bottom line.
The problem is that the money needed to get it up and running is substantial and out of range for Microbix to do on their own at this time and has been for many years.
The clot-busting drug has a storied history, first approved in 1978 as Abbott Laboratories' urokinase and becoming the market leader under the brand name Abbokinase with $300 million in revenue in 1998 before being removed from the market over safety concerns. (not from the drug itself but how materials and the process was handled) The FDA was worried that manufacturing of Abbokinase was not adequately protecting against infections in the neonatal kidney cells being used in the therapy.
Once the market star, the treatment laid dormant, eventually landing under the ownership of Microbix via the company acquiring the assets related to urokinase from ImaRx Therapeutics.
When Microbix acquired the Urokinase assets from ImaRx Therapeutics in 2008, they spent $2.5 million to acquire all the finished product, intellectual property, raw materials, FDA approval to market the product, corresponding sales and marketing infrastructure, and the trade-mark KinlyticTM. As well, Microbix spent an additional $2.8 million on acquiring all rights to the generic Urokinase products from a previous partner, Genpharm, in 2006, as well as the new Toronto manufacturing facility (leased until July 2013) along with leasehold improvements. Thus, Microbix’ total investment in its Urokinase franchise stands at about $5.3 million. There may be other expenses which Microbix expended in developing expertise in Urokinase.
Microbix has manufactured the human protein at commercial scale with requisite precautions to re-introduce Kinlytic as competitor to tPA (tissue plaminogen activator), the only approved thromolytic drug available today. Microbix believes it's ready to re-launch its product under the Kinlytic brand name with the blessing of regulators into a U.S. thrombosis market exceeding $1 billion annually.
And 13 years later we are still waiting.
Lumisort was on the books from 2012 to last year when it was dropped. Too much competition for that one and it also cost a lot of money over the years.
Everything that MBX is doing now is going to be very profitable and continue to do so for a very long time. Just need the Income statements to back it up,then things will be much better.