Verastem(US:VSTM)2019-08-02 04:48Financial Data and Key Metrics Changes - Net product revenue for Q2 2019 was $3 million, reflecting an 81% increase compared to Q1 2019, with no product revenue in Q2 2018 as COPIKTRA was approved in September 2018 [40][48] - License and collaboration revenue for Q2 2019 was $0.1 million, down from $10 million in Q2 2018, which included a significant upfront payment from Yakult [41] - Research and development expenses decreased to $11.3 million in Q2 2019 from $12.4 million in Q2 2018, primarily due to reduced consulting fees and lower R&D costs [42] - Selling, general and administrative expenses increased to $29.3 million in Q2 2019 from $15.8 million in Q2 2018, mainly due to higher personnel costs and promotional expenses [43] - Net loss for Q2 2019 was $42.2 million, or $0.57 per share, compared to a net loss of $18.4 million, or $0.30 per share, in Q2 2018 [44] - Non-GAAP adjusted net loss for Q2 2019 was $35.7 million, or $0.48 per share, compared to $16.7 million, or $0.27 per share, in Q2 2018 [45] - Cash and investments as of June 30, 2019, were $187.3 million, down from $249.7 million at the end of 2018 [47] Business Line Data and Key Metrics Changes - COPIKTRA net revenues in Q2 2019 were $3 million, with a significant increase in the number of prescribing physicians by over 50% [17][18] - The company raised its revenue guidance for COPIKTRA for 2019 to a range of $12 million to $14 million, up from the previous guidance of $10 million to $12 million [48] Market Data and Key Metrics Changes - The company executed a new strategic partnership with Sanofi for COPIKTRA in Russia and CIS, Turkey, the Middle East, and Africa, which includes an upfront payment of $5 million and potential future payments of up to $42 million [49][50] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven for both commercial and clinical COPIKTRA programs within two years and to broaden indications for COPIKTRA and have at least one additional marketed product within five years [24][25] - The focus is on executing a fully integrated sustainable biopharma company model, with a strong emphasis on the commercial launch of COPIKTRA and expanding its footprint into additional indications [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to realize the full commercial and clinical potential of COPIKTRA and emphasized the importance of physician education efforts [14][18] - The management team is optimistic about the early signs of success in the COPIKTRA launch and plans to build on this momentum for the remainder of 2019 [19][53] Other Important Information - The company is actively pursuing regulatory approval in Europe and plans to submit its Marketing Authorization Application (MAA) by the end of 2019 [52] - The company is also working on initiating several key clinical trials, including a confirmatory Phase III study for COPIKTRA [38][52] Q&A Session Summary Question: Discussion on alternative dosing strategies and their potential commercial impact - Management indicated that proactive dose interruptions could allow patients to stay on the drug longer, potentially enhancing commercial outcomes [59][60] Question: Feedback on colitis management and physician education - Management noted that there has not been significant colitis reported and emphasized ongoing educational efforts to support physicians [61][62] Question: Revenue uptick and its implications - Management acknowledged an increase in noise around the product now that marketing is active, indicating a positive trend in sales [64] Question: Trends in R&D spending and future expectations - Current R&D spending is around $40 million to $45 million annually, with expectations for this trend to continue in the near term [68][72] Question: Clarification on revenue increase and prescription data discrepancies - Management explained that prescription data in specialty markets can be less accurate and emphasized the importance of looking at quarterly results for a clearer picture [78][80] Question: Combination studies with checkpoint inhibitors and partnerships - Management confirmed ongoing studies and indicated that they are not currently establishing partnerships for drug supply but may consider it in the future [84][85] Question: Update on enrollment in combination trials and mechanistic differentiation - Management stated that while they hear anecdotal updates on trials, they do not have specific guidance on enrollment or data presentation timelines [96]