Evoke Pharma(US:EVOK)2021-03-12 03:29Financial Data and Key Metrics Changes - For Q4 2020, net sales were approximately $23,000, with a net loss of approximately $2.3 million or $0.09 per share, compared to a net loss of approximately $1.4 million or $0.06 per share in Q4 2019 [56] - For the full year 2020, net loss was approximately $13.2 million or $0.52 per share, compared to a net loss of approximately $7.1 million or $0.32 per share in 2019, primarily due to a $5 million expense related to FDA approval of Gimoti [57][58] - Cash and cash equivalents as of December 31, 2020, were approximately $8.1 million, excluding approximately $13.1 million in net proceeds from a common stock offering in January 2021 [63] Business Line Data and Key Metrics Changes - The company successfully launched Gimoti, the first novel treatment for diabetic gastroparesis in four decades, and is now positioned as a commercial pharma company [11][20] - The sales force is targeting gastroenterologists and select healthcare providers familiar with oral medications for diabetic gastroparesis [17] Market Data and Key Metrics Changes - The estimated market opportunity for diabetic gastroparesis treatment includes 12 million to 16 million patients, with only 2 million to 3 million currently treated [14][15] - Approximately 3 million prescriptions of oral metoclopramide are written annually in the U.S. for gastroparesis [15] Company Strategy and Development Direction - The company aims to position Gimoti as the drug of choice for diabetic gastroparesis, focusing on educating healthcare providers about its benefits [16] - The partnership with Eversana allows the company to leverage their infrastructure and expertise for commercialization, avoiding significant capital investment [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the positive response from healthcare providers and patients regarding Gimoti, despite challenges posed by the COVID-19 pandemic [9][50] - The company is encouraged by the increasing access to healthcare providers and expects improved patient visits as vaccination rates rise [76] Other Important Information - The company has registered with CMS to participate in Medicare Part D and Medicaid programs, which is crucial for patient access [45] - The company plans to initiate a social and digital campaign to enhance patient engagement and awareness of Gimoti [42] Q&A Session Summary Question: How many physicians prescribed Gimoti to date, and what percentage are repeat prescribers? - As of now, there are 108 unique prescribers, with about 30% to 40% being repeat prescribers [66] Question: What percentage of gastroenterologists are prescribing Gimoti? - The vast majority of prescribers are gastroenterologists, with some primary care physicians affiliated with gastroenterology practices [67] Question: How is the promotional performance provided by Eversana? - The company is currently analyzing promotional effectiveness and will provide metrics in the future [68] Question: What do the gross net discount levels look like? - It is too early to provide specific numbers due to modest sales, but contracting has not negatively affected sales thus far [69] Question: Can you elaborate on the positive trends observed this year? - The company has seen significant traction in prescriptions since the beginning of the year, despite initial slow uptake due to the pandemic [72] Question: What is the current trend of patients visiting clinics? - Data indicates that 41% of chronic care patients were avoiding care, but this is expected to improve as vaccination rates increase [75] Question: What are the prior authorization requirements for Gimoti? - Most plans require prior authorization, but the majority of dispenses have been approved by commercial plans, Medicare, or TRICARE [84] Question: Will the company consider taking over the entire commercial sales team? - Currently, the company is satisfied with the partnership with Eversana and does not plan to take over responsibilities at this time [87] Question: When might the company be cash flow positive? - The company has not provided guidance on breakeven analysis due to various moving components [89] Question: Will there be R&D activities for a lower dose of Gimoti? - The company has a post-approval commitment to work on a lower dose, which will begin this year [91]