It's easy for U.S.-based investors to forget that the rules and standards and agencies biotech companies must deal with here in North America aren't the same ones the biopharma industry must navigate overseas. Fortunately, the savvy marketing team at young biotech outfit TNI Biotech Inc. (OTCMKTS:TNIB) knows there's a whole world of opportunity out there outside the borders of the United States, and they're tapping into it quite nicely. Indeed, TNIB added another foreign profit center today, making it an increasingly international company... with real revenue just around the corner.
If you're reading this, then odds are you already know TNIB is ready to make a big sales splash in Nigeria next year. Back in early October TNI Biotech announced a partner company in that country - AHAR Pharma - was taking the Lodonal ball and running with it in that country.
Lodonal is the trade-name for low-dose naltrexone, for which TNIB owns a great number of marketing rights and IP. The drug, though not yet approved in the U.S., has been approved in several other countries as a treatment for everything from HIV to multiple sclerosis to some forms of cancer. It can effectively combat those ailments because rather than being built from the ground up to find and kill one specific type of diseased cell, it can enhance a patient's entire immune system to fight a variety of illnesses.
More important to TNI Biotech Inc. shareholders, the deal with AHAR Pharma guarantees at least $53 million in revenue for the company this year via sales of Lodonal, with $1 million worth of orders to be placed before the end of January. (It's possible that order has already been shipped, and perhaps even payment has been booked.)
Here's the thing... the Nigerian market isn't even close to being the only overseas market where Lodonal is ready to legally sell.
Fast forward to today's news. Per this morning's press release, TNI Biotech Inc. - through its manufacturing partner in that country - will be able to sell Lodonal in Nicaragua, making it the fifth country where the low-dose naltrexone product can be marketed. In addition to Nigeria and Nicaragua, LDN can be marketed in Equatorial Guinea, Malawi and Gabon.
Nicaragua's population is about 6 million, and Nigeria is home to about 169 individuals. Between Equatorial Guinea, Malawi and Gabon, that's another 18 million people in need of a treatment like TNI Biotech's low-dose naltrexone. All told, TNIB now has access to 193 million residents and potential patients in markets that are largely underserved and until now didn't have a great deal of access to top-of-the-line healthcare choices. That's a big coup for TNI.
Yes, the proverbial big Kahuna is still the United States healthcare market, and then perhaps the EU. TNI Biotech is working on them; LDN is ready to begin Phase 3 testing as a therapy for Crohn's next year, with a possible FDA approval coming as soon as 2017. Lodonal as a therapy for multiple sclerosis could be approved as soon as 2018. In the meantime, TNIB has something that few other small biotech companies have... access to revenue to fund its future R&D. Indeed, it's conceivable that TNI Biotech would never need to go out and raise money by issuing stock again, as it's pieced together a viable, revenue-generating, overseas customer base. That alone could make TNIB a worthy trade here (as if the biotechnology itself wasn't enough).
For more about TNI Biotech, visit the company website here.