Below please find answers and guidance to questions received at email@example.com. Repeat questions of the same topic are combined, and similarly themed questions are grouped together.
The Sanofi collaboration agreement terminated on April 5, 2016. At that time, we signed a transition agreement, whereby Sanofi agreed to supply Afrezza to the market until such time as we were able to do so ourselves, or October 1, 2016, whichever came first. As announced on August 1, we now have MannKind branded product in commercial channels and available for purchase, so the agreement with Sanofi in winding down.
We expect that the third quarter of 2016 will be the final quarter of our profit and loss sharing arrangement with Sanofi; however, certain aspects of our relationship with Sanofi will continue beyond this date. As examples, our indebtedness under the loan facility with Sanofi will not mature until August 2024 and Sanofi’s obligations under the “Insulin put” will continue until Sanofi’s share of our current and future insulin purchases accumulates to $50 million. Under the terms negotiated with Sanofi, another payment from them is anticipated late this year, and payments will continue to be made periodically for at least the next couple of years.
While discussions with international partners are ongoing, we are not able to project a timeline for any deal. We are necessarily concentrating on the US market first, both because of limited bandwidth and because it is unlikely that an attractive international deal would be finalized before we are able to demonstrate the viability of the product in the US.
At the time Sanofi initially launched Afrezza, it carried a significant price premium compared to injected rapid acting analogs. Since then, those other insulins have raised their prices multiple times, while Afrezza has kept the same pricing, or even reduced pricing on new product configurations. As a result, we no longer believe that pricing is an impediment.
While we have no intention of forecasting sales in the near term, we are investigating our ability to post prescription data on our web site or similar accessible portal under the terms of our subscription agreement with the provider of this data.
You are correct that these centers are not affiliated with MannKind in any way. While we think they make a lot of sense, we are not privy to all the details behind delays experienced in their opening. We have received unsubstantiated reports that complications arose with plans to open the first centers in New Jersey and the decision was made to instead open them in California. But we do not have further information at this time.
We have recently redesigned and updated our corporate website as well as the separate dedicated website for Afrezza. Both are going through final review and should be rolled out very soon.
Please submit your question using the form below. * Required fields