Pipeline is worth significantly more than the voucher. The voucher comes as a freebie once the FDA approves the skin in peds for a rare indication (the pediatric nevus indication).
Think of pipeline as $X billions (ESS, Elt. and MANF) and the voucher as the frequent flier points ($250 million). Great move - using incentives available to get more for something you were going to do anyway.
The pediatric voucher program (FDA priority review voucher extension that became law in 2012) includes several changes that had been sought for the neglected-disease voucher program, but apply only to pediatric vouchers. MAKES THE VOUCHER MORE VALUABLE than for neglected disease PVR voucher. A key part - can be sold multiple times (think AMBS sells it quickly to a capital partner who buys it at a discount and then sells to Pharma).
First, the pediatric treatment developer can ask the FDA in advance for an indication of whether the disease qualifies as a rare, pediatric disease. Second, the pediatric voucher can be transferred an unlimited number of times, whereas the neglected-disease voucher can only be transferred once. Third, the pediatric voucher user needs to notify FDA 90 days prior to using the voucher, rather than 1 year for the neglected-disease voucher. Fourth, the pediatric voucher winner risks having the voucher revoked if the treatment is not marketed within a year. Fifth, the pediatric voucher winner must report to FDA about use of the pediatric treatment within five years of approval.
$250 mm ---- Priority review voucher = $250 million in cash in sale to big pharma if received
$ ESS (engineered skin) - burns.
$ ESS - vascular wounds (Diabetic ulcers -- they haven't spoken about it but huge opportunity)
$ Eltoprazine --- Parkinsons + ADHD
$ MANF - Retinal (with a drug that stops cells in general from dying -- Heart attack, Alz other)
$ Diagnostic division
$ NASDAQ uplisting (impact on share price stability and investor pool)
$1 billion = 100x current value. Could easily end up more.
@$50 million this was a good deal. @$10 million - 5x gets it back to where it was recently as a good deal!
Economists at Duke University, who published on this concept [Priority Review Voucher] in 2006, estimated that priority review can cut the FDA review process from an average of 18 months down to six months, shortening by as much as a full year the time it takes for the company’s drug to reach the market.
For a company with a top selling drug with a net present value close to $3 billion, the Duke researchers calculated the accelerated approval could be worth over $300 million
ESS could earn one of these if it gets the pediatric Nevus designation