Vericel Corp. (VCEL)

[realfast95]

NexoBrid DD - part 1 - short term for VCEL


Biomedical Advanced Research and Development Authority (BARDA)
https://www.phe.gov/about/barda/Pages/default.aspx

Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, was established to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats,..

From Q1 earnings transcript
We anticipate the first NexoBrid sales in the U.S. to come from purchases under existing BARDA contract, which included $16.5 million commitment for cerement of NexoBrid, contingent upon FDA eligibility for use in an emergency or FDA marketing approval.

Since MediWound holds the BARDA contracts, they will supply the product to BARDA. And we will participate via a proper channel formula, which you deal to Vericel approximately $6 million in revenue with no associated cost of goods. BARDA has not yet placed an order, and therefore, we are not including any procurement revenue in our 2019 revenue guidance. Once an order is placed, we would expect it to be filled over the course of 4to 6 quarters. We will update our 2019 revenue guidance as appropriate when we gain clarity on the timing of BARDA procurement orders. Longer term, BARDA has the option to make up to $50 million of additional NexoBrid purchases, which could yield up to $25 million in profit sharing for Vericel over approximately 10 years.

https://seekingalpha.com/article/4261334-vericel-corporation-vcel-ceo-nick-colangelo-q1-2019-results-earnings-call-transcript?page=6

I found it very enlightening that he is talking about 2019 guidance
when the quickest for FDA approval is 2020.

The pre-BLA meeting is planned for later this quarter, at which time we’ll have additional clarity on the BLA submission timelines.
https://seekingalpha.com/article/4261334-vericel-corporation-vcel-ceo-nick-colangelo-q1-2019-results-earnings-call-transcript?page=7