Xeris Biopharma(US:XERS)2021-05-12 17:10Financial Data and Key Metrics Changes - Net revenue from KEVEYIS increased by $1.7 million or 25% to $8.4 million compared to $6.7 million for the same period in 2020 [19][22] - Gross margins improved to 95% from 85% in the same period last year [22] - Basic net loss attributable to ordinary shareholders decreased to $11.8 million or $0.18 per share from $12.7 million or $0.23 per share in the same period in 2020 [24][25] - Non-GAAP basic net loss attributable to ordinary shareholders was $7.2 million or $0.11 per share compared to $10.3 million or $0.19 per share for the same period in 2020 [25] Business Line Data and Key Metrics Changes - KEVEYIS achieved strong sales results with a 25% quarter-over-quarter revenue growth, marking the highest month of revenue ever in April since its launch in 2017 [10][19] - The company remains on track to achieve full-year KEVEYIS revenue guidance of $34 million to $36 million [10][67] Market Data and Key Metrics Changes - The company is awaiting the Day 74 Letter from the FDA regarding the NDA submission for RECORLEV, which is expected to confirm filing acceptance and provide a target action date [15][37] - Market research indicates significant unmet needs in the treatment of endogenous Cushing's syndrome, particularly among women [6][32] Company Strategy and Development Direction - The company is focused on driving continued revenue growth for KEVEYIS while preparing for the launch of RECORLEV upon FDA approval [12][21] - Strongbridge aims to optimize the value of RECORLEV and strengthen its leadership position in rare endocrine diseases [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for RECORLEV to address unmet needs in the Cushing's syndrome market, with a focus on patients not well controlled by current therapies [32][49] - The company anticipates a cash runway extending into and potentially beyond the first quarter of 2023, providing flexibility for future capital access [26] Other Important Information - Strongbridge was recognized as a 2021 Great Place to Work certified company, highlighting its positive workplace culture [13] - The company is actively pursuing intellectual property developments related to both KEVEYIS and RECORLEV [11][68] Q&A Session Summary Question: What are the key drivers for the improved discontinuation rate for KEVEYIS? - Management highlighted the importance of setting expectations with physicians and patients early in the treatment cycle and improving engagement through consistent communication [30] Question: What is the expected pent-up demand for RECORLEV upon launch? - Management noted significant unmet needs, with up to 40% of patients not well controlled, indicating potential demand for RECORLEV [32] Question: What feedback has been received regarding RECORLEV data? - Physicians have expressed that RECORLEV's titration scheme and efficacy are competitive, with potential advantages for women experiencing androgenic side effects [45][46] Question: How does being an Irish company impact tax strategies? - Management indicated potential tax advantages due to expected increases in corporate tax rates in the U.S. compared to anticipated rates for an Irish company [38] Question: Are there updates on KEVEYIS IP? - The company continues to prosecute its IP and expects to provide further updates in the second half of the year [68]