Verastem(US:VSTM)2019-03-13 02:52Financial Data and Key Metrics Changes - As of December 31, 2018, Verastem Oncology had cash and investments of $249.7 million, compared to $86.7 million as of December 31, 2017 [59] - Net product revenue for the full year 2018 was $1.7 million, compared to zero product revenue for the full year 2017 [60] - License revenue for the full year 2018 was $25 million, related to license agreements with Yakult and CSPC [61] - Net loss for the full year 2018 was $72.4 million or $1.12 per share, compared to a net loss of $67.8 million or $1.76 per share for the full year 2017 [63] Business Line Data and Key Metrics Changes - The commercial performance of COPIKTRA achieved $1.7 million in net product revenues since its launch in late September 2018 [25] - As of year-end 2018, reimbursement approval for COPIKTRA was secured for approximately 75% of major targeted health plans, representing 240 million US lives, which increased to over 90% shortly thereafter [25] Market Data and Key Metrics Changes - In the US, nearly 350,000 patients are living with CLL/SLL or FL, with a significant number cycling through several lines of therapy due to the chronic nature of these diseases [27] - The treatment landscape for CLL and FL is characterized by limited options for patients who cannot tolerate existing therapies, highlighting the potential role of COPIKTRA [28] Company Strategy and Development Direction - The company aims to expand the use of COPIKTRA in additional lines of therapy for CLL/SLL and FL, as well as explore its potential in other hematologic malignancies and solid tumors [42][44] - Strategic collaborations with Yakult and CSPC are in place to develop and commercialize COPIKTRA in Japan and China, respectively [16][17] - The company is focused on increasing awareness and adoption of COPIKTRA while addressing negative perceptions associated with PI3K inhibitors [67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic and operational plans, emphasizing the importance of educating healthcare professionals about COPIKTRA [72] - The company anticipates a steady build in COPIKTRA's launch throughout 2019, with ongoing efforts to increase the number of doctors prescribing the drug [39][40] Other Important Information - COPIKTRA received its first marketing approval from the FDA in late September 2018 for the treatment of relapsed or refractory CLL/SLL and FL [9][10] - The company has initiated a Risk Evaluation and Mitigation Strategy (REMS) program to inform healthcare providers and patients about the risks associated with COPIKTRA [11] Q&A Session Summary Question: Has there been any evolution in the sales and education message to physicians regarding COPIKTRA? - Management indicated that the messaging has evolved from focusing on dual inhibition to emphasizing efficacy and safety, particularly in the context of FL [74][75] Question: Can you provide commentary on expenses for 2019? - The company will not provide specific guidance on expenses but noted that operating expenses were about $35 million in the last quarter of 2018 [76][77] Question: What education programs are planned to increase clinician experience with COPIKTRA? - The company is developing programs to identify patients who fit the treatment criteria for COPIKTRA, focusing on those who have undergone two prior lines of therapy [79][82] Question: How does the current experience with COPIKTRA compare to previous drug launches? - Management noted that building a base of support and physician experience is crucial, and they are actively working to enhance this through educational efforts [87] Question: What are the key catalysts to watch for in 2019 regarding COPIKTRA? - The focus will be on executing the launch, maximizing the potential for duvelisib, and exploring new indications and combinations [102][103]