At June 30, 2018, we had $19.9 million of cash and cash equivalents.
As at August 9, 2018 we had 16,440,760, common shares issued and outstanding, as well as 161,000 deferred stock units and 973,717 stock options outstanding. Share purchase warrants outstanding as at August 9, 2018 represented a total of 3,417,840 equivalent common shares.
Mac:
>24 Mio$ Stongbridge Upfront gezahlt im Jan 18
>15% royalty on annual net sales up to $75.0 million and an 18% royalty on annual net sales above $75.0 million (On July 23, 2018, Strongbridge launched product sales of Macrilen) Im Nov 18 werden die ersten Verkaufszahlen im Q3 erscheinen.
> Einmalzahlung nach einem 1Jährigen Verkaufserlös (ersichtlich im Q3 2019 AEterna)
•$4.0 million on achieving $25.0 million annual net sales,
•$10.0 million on achieving $50.0 million annual net sales, •$20.0 million on achieving $100.0 million annual net sales, •$40.0 million on achieving $200.0 million annual net sales, and •$100.0 million on achieving $500.0 million annual net sales.
>Upon approval by the FDA of a pediatric indication for Macrilen/ one-time milestone payment of $5.0 million
>Strongbridge agrees to fund 70% of the costs of a worldwide pediatric development program We are not currently conducting any clinical studies, but expect to start enrollment for the clinical trial for a pediatric indication of Macrilen™ (macimorelin) in late 2018.
>EMA
On November 27, 2017, we announced that the MAA for the use of MacrilenTM (macimorelin) for the evaluation of AGHD has been accepted by the EMA for regulatory review.
The start of the EMA review procedure for the MAA has been confirmed by EMA as November 23, 2017.
On March 23, 2018, we received from the EMA a Day 120 List of Questions, which was issued in connection with our MMA submission for MacrilenTM (macimorelin). We submitted our responses to the EMA for its Day 120 List of Questions on July 20, 2018.
EMA wird noch in 2018 entscheiden !
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2018:
1. EMA Entscheid
2. Anfang pediaticstudie
3. Nov - Erste Verkaufszahlen für Mac
2019:
Lizensvereinbarung EU?
Strongebridge royality und einmaltahlung im Q3 ersichtlich
2020:
Q1- Q2 ende Cash ohne Strongbridgezahlungen aus 2019 (pediaticstudie mit eingerechnet)
1.5 Ablaufdatum Nov 16 Warrants (945T zu 4,7$) (call option)
9.12. Ablaufdatum Dez 15 Warrants (2,331Mio zu 7,1$)
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