10/17/17
Q: Mike C eluded to international expansion many times. Besides the upcoming filing in Brazil by Biomm, what are other expansions? UAE, Mexico, Canada? The later two and U.S. Are members of NAFTA, having no tariff, low cost of shipping thereby making Afrezza 25% cheaper in those countries. What are we waiting for?
Oman is newly added also on the expansion map.
Is it safe to say any expansion in USE will have nclude Oman, Saudi Arabia?
A: We continue to update on our international expansion at every opportunity as it represents a means of expanding Afrezza sales, one of two top priorities expressed by both Mike and Steve, the other being recapitalization. As Mike stated in August, we are still on track to file by the end of the year in Brazil, if not sooner. As you may surmise, with the recent approved label update, our partner, BIOMM, wanted to reflect the FDA's approval in its filing with ANVISA. The timelines with respect to other international opportunities vary based on regulatory requirements in each country and potential partnership discussions always seem to take longer than originally anticipated. We are currently targeting Canada, Mexico, India and China in the near term and, as you know, after following MNKD all these years, we would not make any announcements until there is a definitive partnership agreement in place. UAE has always been an area which Al felt passionate about. We continue to work with international regulatory experts to prioritize our expansion.
Q: When is the next ER?
Please know that we are in our quiet period prior to our upcoming earnings call to be scheduled by or prior to the mandated 10-Q filing date of 11/9/17. As you may know, there is coordination required with executive calendars (Mike and Steve have been extremely busy on our recap solutions as disclosed a few times this quarter), the auditors, Deloitte, and our own financial close calendar given the other transactions that have diverted attention ($61M direct placement offering). As our standard practice, we will announce our earnings call at least a week prior to.
Q: Who is the new 10M share owner? That's more than 5%. Don't they need to file Sch 13 D within 10 days of 10/13/17? Maxim mentioned it was a fundamental health care group.
A: Please refer to our 8-K filing related to the direct placement offering settled on Friday, 10/13/17. The investors were not disclosed and should there be a Sch 13 requirement, it is incumbent on the investor to comply.
Q: What are the new payors that will cover Afrezza as tier 2, no PA, no STEP, for 2018?
A: We continue to make progress on the payer access front and anticipate improvements given the recent FDA approved label change. I anticipate Mike will update on payer access. I’m not aware that the label change moved Afrezza to tier 2, but let me follow up with our Market Access executive.
Q: When does Mnkd publish STAT result? By which media channel?
A: STAT is an independent, investigator-led study. Accordingly, MNKD does not manage the study. We believe final patient visits and information will be collected over the coming weeks and then analyzed. We anticipate that Dr. Garg will share top-line results with us as soon as available with an expectation that study results will be presented in 2018. I trust you understand that we are not able to give guidance on expectations or study outcomes at this time.
c.
Q: Does Mnkd plan to partner for inhaled Tresprostinil or go alone?
A: As Mike has disclosed, we anticipate filing a pre-IND for Trespostinil and have not focused on partnering this initial step as we currently have the resources to do so internally, hopefully attracting the appropriate partner to take it to the next step, if needed.
Q: When will Mnkd finish training the sale force on the new label?
A: We quickly mobilized sales training and collateral upon receiving FDA’s approval of the label change. The entire sales force was pulled from the field, east coast in the latter part of the week after receiving approval and the west coast contingency in the early part of the following week. This week represents the first full week the entire sales force is in their respective territories.