Trilogy International Partners Inc T.TRL.WT.A

My CC Notes: Rossi "Very Very Excited"

[LTOWNER]

CEO Rossi concluded the conference call by saying management is “very very excited with what lies ahead, they have a very busy year ahead and they are looking forward to what they believe will be a successful transformation in 2014.”
 
Compleo

• If Compleo is approved by the end of May, commercial launch is expected in early 2015
• Discussions continue with potential partners both for US markets and markets outside the US
• A partnership agreement on Compleo will “likely not involve both products” (i.e. not be linked with Tefina)
• Discussions continue with the FDA.  The information requested in February by the FDA was exactly as expected.  They want Trimel to justify and support the LT safety & exposure of the TID dose.  The P3 provided 50 BID and TID patients followed for 360 days.  Now the application is for TID only, they must extract safety for TID which they have done for 40 patients – they are confident this will be accepted.  Although they have 40 patients and not 50, TID patients end up with over 1000 exposures (more than BID in the same time period) and there was no safety difference seen between TID and BID patients. 

 Tefina

• Top-line data is expected in late May
• There have been some “conversations with major pharmas” re Tefina ; robust results from the P2 will take  discussions  further
• Trimel is “very happy to see Sprout get another kick at the can” with their FOD product.  “Approval would be a good thing, the more players the better for us (they would) lay groundwork”
• With topline results in late May, “the company will discuss the next step with the FDA.  They could go straight into a P3 – there is no clarity on that issue yet.”

General

• The new Chairman has a new vision for the business.  They are open to look at opportunities outside strict drug development.  They are always looking to build the business.
• They are now on good terms with M&P and would welcome future opportunities with the relationship as it is now.  The IN platform is novel and has a lot of potential opportunities.  M&P have other drugs in P1 and P2
• There is enough cash to take the company to the end of 2014 (includes milestone payment on Compleo approval, does not include up-front cash payments from partner agreements