Veru(US:VERU)2020-02-12 19:50Financial Data and Key Metrics Changes - The company reported Q1 fiscal year 2020 revenue of $10.6 million, up 66% from $6.4 million in Q1 fiscal year 2019 [24] - Gross profit increased to $7.3 million with a gross margin of 69%, compared to $4.6 million and a gross margin of 73% in the prior year [30] - The net loss for the quarter was $3.3 million or $0.05 per share, compared to a net loss of $2.1 million or $0.03 per share in the prior year [32] Business Line Data and Key Metrics Changes - FC2 unit sales totaled $10.1 million, up 36% from $7.4 million in the prior year [27] - Prescription business revenue was $6.1 million, an increase of 148% from $2.4 million in the prior year [28] - Revenue from PREBOOST/Roman Swipes was $153,000, compared to $47,000 in the prior year [28] Market Data and Key Metrics Changes - The global market for prostate cancer management is estimated to be a multibillion-dollar market, with a specific focus on unmet medical needs [7] - The market for patients who have failed novel androgen blocking agents is estimated to represent a $4.5 billion annual global market [10] - The peak U.S. revenue potential for zuclomiphene is projected to be between $580 million to $630 million [20] Company Strategy and Development Direction - The company aims to be the leading provider of prostate cancer treatments, focusing on developing and commercializing products to address unmet medical needs [6][7] - Plans to expand the clinical program of VERU-111 into Phase 2 studies with additional tumor types are underway [15] - The company intends to submit an NDA for TADFIN by the end of 2020, which is expected to be its first pharmaceutical urology asset to move into commercialization [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued revenue growth and the potential for a record year in fiscal 2020 [35] - The company anticipates a steady flow of positive news regarding clinical trials and product development over the next year [36] - Management highlighted the importance of the telemedicine sales channel for FC2, which has significantly contributed to revenue growth without traditional marketing costs [60] Other Important Information - Research and development costs increased to $5.3 million from $2.4 million in the prior year, reflecting the advancement of multiple drug candidates [31] - The company has a net operating loss carry-forward for U.S. federal tax purposes of $42.7 million [32] - The cash balance as of December 31, 2019, was $4.2 million, down from $6.3 million at the end of the previous quarter [33] Q&A Session Summary Question: Can you provide more details on the baseline characteristics of the four men on VERU-111 who responded well? - Management noted that the patients typically had bone metastasis or lymph node involvement, which is common in prostate cancer cases [40] Question: What is the competitive environment for VERU-111 in the prostate cancer market? - Management indicated that there are currently no approved drugs for patients who fail ADT and one of the androgen blocking agents, positioning VERU-111 favorably in the market [41] Question: How should we think about operating expenditure for the rest of the year? - Management stated that revenues and gross profits are expected to meet operational needs, allowing for continued investment in promising programs [46] Question: What are the two to three indications being considered for VERU-111? - Management mentioned pancreatic cancer, breast cancer, and post-taxane prostate cancer as potential indications [51] Question: What is the expected sample size for the Phase 3 study of zuclomiphene? - Management indicated that the study would likely involve about 240 to 260 patients, with a 12-week treatment period [53]