Verastem(US:VSTM)2019-05-10 02:56Financial Data and Key Metrics Changes - For Q1 2019, net product revenue was $1.7 million, reflecting a 38% increase from Q4 2018 [10][17] - Cash and investments as of March 31, 2019, were $211.7 million, down from $249.7 million as of December 31, 2018 [37] - Net loss for Q1 2019 was $38.1 million, or $0.52 per share, compared to a net loss of $21.1 million, or $0.41 per share, in Q1 2018 [42] Business Line Data and Key Metrics Changes - COPIKTRA, the lead oncology drug, had net revenues of $1.7 million in Q1 2019, marking a 38% increase from the previous quarter [10][17] - Selling, general and administrative expenses rose to $26 million in Q1 2019, a 165% increase from $9.8 million in Q1 2018, primarily due to higher personnel and promotional costs [41] Market Data and Key Metrics Changes - The company reported that over 92% of targeted health plans are now providing reimbursement for COPIKTRA [18] - The estimated patient population in need of new therapeutic options for CLL/SLL and FL is approximately 20,000 patients per year [24] Company Strategy and Development Direction - The company aims to continue executing the commercial launch of COPIKTRA and expand into additional investigational studies [45] - Plans include initiating a confirmatory Phase III study for COPIKTRA in FL and expanding the Phase II PRIMO study for PTCL [45][35] - The company is also exploring ex-U.S. partnership opportunities for duvelisib [53] Management's Comments on Operating Environment and Future Outlook - Management views 2019 as a foundational year for COPIKTRA, with expectations for increased sales momentum in 2020 [51] - The company is confident in overcoming headwinds related to negative perceptions of PI3K and is seeing positive signs in physician engagement and education efforts [51] Other Important Information - Joseph Lobacki, the Chief Commercial Officer, will be stepping down during 2019, with a search for his successor already underway [13] - The company has amended its loan agreement to lower interest rates and extend repayment timelines, increasing the borrowing limit from $50 million to $75 million [38] Q&A Session Summary Question: Guidance lower than expected - Management acknowledged the guidance is lower than anticipated, citing headwinds and current market traction as factors influencing the estimate [48][49] Question: Metrics for overcoming PI3K headwinds - Management highlighted increased podium presence and engagement with KOLs as positive indicators of progress in overcoming headwinds [51] Question: Ex-U.S. opportunities - The company is in discussions for additional partnerships outside the U.S., with expectations for at least one partnership by the end of the year [54] Question: Update on defactinib program - Management confirmed that defactinib is involved in four separate programs, with data expected from several of these studies at medical meetings later this year [59][60] Question: Impact of venetoclax on COPIKTRA's positioning - Management discussed the potential for COPIKTRA to fill a significant need in the third-line treatment space for CLL/SLL and FL, especially as oral therapies gain traction [62][64]