Stream of Conscience take on 4th Q CC
- So for the last full quarterly results while owning the ‘boring’ cancer drugs we got an uptick in revenue of ~15%. Less relevant now but still a nice uptick. It’s prolly due to an increase in inventory but, Hey, it still goes to the bottom line.
- A little bummed that they revised hearing about top-line results to the 4th Q of this year for the previously treated EGFR cohort (as opposed to 1st half). They currently have the confirmatory scans on RRs and by the end of June will have 6m data on DoR. It doesn’t take much longer to make sure your Is are dotted and Ts crossed but they need to make sure w the FDA on what they should present and having meetings w them takes time. If we had BTD, w constant communication w the agency, I’d have no doubt that would occur in the 3rd Q. And as an aside, if I recall correctly from the Ariad references AVII provided, Araid was able to submit their data after 5m from last dose. If Spectrum’s dates are accurate, the bummer in all this is we won’t be expecting Z20 data at WCWL in early Sept.
- Using above as a template, the previously treated HER2 Z20 data w enrollment completed in the 4th Q 2019 and for argument sake let’s assume completion at the midpoint i.e. Nov 15th. The latest we’d get topline on that would be sometime in the 3rd Q but hoping the EGFR cohort smooths the way for HER2 (perhaps BTD for HER2). Regarding the MDACC HER2 cohort, that data should be mature this year, perhaps we get data at ASCO or WL?
- With the Rolontis inventory buildup, and w their ‘positive’ conversations w the agency, I think the Rolontis approval is a formality but still only expecting to see revenue in 2020 and more noticeable revenue in 2021.
- They’ll be able to run operations for 3 years w the cash at hand (157.5M) and the 160M from the sale of assets. That includes the Rolontis commercial build out and pozi clinical studies but doesn’t project any cash coming in from Rolontis or selling their marketable securities i.e. CASI shares (or does it?). So we got 2 years before they go to Wall Street for more cash. By that time we’ll start seeing what the sales trajectory will be for Rolontis and pozi will have a couple of approvals under its belt.
- Poor apaziquone. I’m sad and happy. I’m sad that there won’t be another tool in the shed but the spiteful me says they should never have started another P3 w/o getting some temporary approval to sell the drug based on the combined data presented. Wrote a song about it, it goes something like this… Poor Qapzola dead and gone, left me here to sing its song, pretty little girl w a red dress on. Poor Qapzola dead and gone (OK, ok there was a little help from the Doors on that one).
As an optimistic long I wouldn't be surprised if we get other news by the end of the year too such as perhaps a BTD for a cohort of pozi (I know, I know) or a EU licensing deal. Regarding in-licencing, I have no problem, and prefer, that is pushed into 2020 or 2021 so they focus, w/o dilution, what they have got at hand.
AI
