Verastem Oncology
VSTM
conference date: August 8, 2018 (press release only)
for quarter ending: June 30, 2018 (Q2, second quarter 2018)
No conference was held, this is a summary of the press release.
Forward-looking
statements
Overview: Clincal stage company may be going commercial if FDA approves duvelisib for CLL.
Basic data (GAAP):
There was $10.0 million revenue in the quarter, from a milestone payment, versus none year-earlier..
Net income was negative $18.4 million, up sequentially from negative $21.1 million, but down from negative $13.5 million year-earlier.
EPS, diluted, was negative $0.30, up sequentially from negative $0.41, and up from negative $0.36 year-earlier.
Guidance:
Cash is sufficient to last into 2020.
Conference Highlights:
Robert Forrester, CEO of Verastem, said "During the second quarter of 2018, we’ve been actively preparing for the commercialization of duvelisib, our first-in-class, oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma (FL). In advance of our target action date of October 5, 2018, we have been building our U.S. sales force and commercial capabilities in preparation for a potential product launch of duvelisib in the U.S. in 2018. On the financial front, we have significantly strengthened our balance sheet, ending June 30, 2018 with $168.7 million in cash and cash equivalents."
In April the NDA was accepted bu the FDA for priority review of duvelisib, a P13K inhibitor, for treatment of relapsed or refractory CLL/SLL and FL, and for accelerated approval for relapsed or refractory FL. The supporting Phase 3 study met its primary endpoint and had a manageable safety profile. The data had been presented at ASH.
Verastem signed an exclusive license agreement with Yakult Honsha Co. for duvelisib in Japan. There is a $10 million upfrong payment plus another potential $90 million in milestone payments and double-digit royalties.
Buildout of the commercial team for duvelisib is led by Joseph Lobaki, former CCO of Medivation.
Clinical and preclinical data was presented at ASCO and EHA during the quarter for duvelisib and defactinib.
In June 2018 Verastem was added to the Russell 3000 index.
Cash and equivalents ended at $168.7 million, up sequentially from $86.7 million. In Q2 sold shares ATM to generate an additional $23.7 million. In May a public share offering generated $38.3 million. In June another $42.8 million was generated by a stock sale to Consonance Capital. Verastem has a $50.0 million line of credit available.
R&D expense was $12.4 million. G&A was $15.8 million. Total operating expense was $28.2 million. Loss from operations was $18.2 million. Interest income $0.3 million, interest expense $0.5 million.
Q&A:
none
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