Veru(US:VERU)2019-12-12 20:04Financial Data and Key Metrics Changes - The company reported significant progress in its clinical development and commercialization efforts, with a focus on prostate cancer treatment and supportive care [6][22] - R&D expenses increased from $10.8 million in 2018 to $13.7 million in 2019, while SG&A expenses remained relatively flat year-to-year [42] Business Line Data and Key Metrics Changes - The company is advancing its prostate cancer drug pipeline, particularly with the VERU-111 clinical trial, which targets metastatic castration-resistant prostate cancer patients [7][21] - The company plans to expand the clinical program of VERU-111 to include additional tumor types, including metastatic pancreatic cancer and metastatic breast cancer [21][22] Market Data and Key Metrics Changes - The markets for prostate cancer treatment and supportive care are established multi-billion dollar markets, positioning the company uniquely to address unmet medical needs [6][22] - The company has secured partnerships and demonstrated robust revenue growth from its commercial products, including PREBOOST/Roman Swipes and FC2 [22] Company Strategy and Development Direction - The company aims to be the leading provider of prostate cancer treatments, focusing on developing and commercializing products that address unmet medical needs [6][22] - The strategy includes expanding into additional cancer types based on preclinical data showing efficacy [21][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for significant anti-tumor activity with VERU-111, noting a wide safety margin [20][28] - The company anticipates continued revenue growth from its commercial products and plans to reassess its financial position by the end of 2021 [75] Other Important Information - The company has not yet reached a maximum tolerated dose for VERU-111, allowing for flexibility in dose selection for future trials [28][40] - The company is actively pursuing partnerships for its products, particularly in Europe and South America [77] Q&A Session Summary Question: Can you provide details on the cohorts with varying response times in the trial? - Management explained that the trial design allows for dose adjustments based on patient response, and they are encouraged by the results seen so far [25][26] Question: How will dose selection be approached for upcoming Phase 2 trials? - Management indicated that they will select a dose in the upper range of what has been tested, based on observed activity and safety [28][29] Question: What are the expected operating expenses for 2020? - R&D expenses are expected to continue increasing, while SG&A expenses will remain stable [42] Question: What is the status of the contracts in Brazil and South Africa? - Management reported increased orders from Brazil and a potential extension of the contract in South Africa, indicating positive revenue expectations [58][60] Question: What is the timeline for getting products to market? - Management outlined expected timelines for product launches, with VERU-111 anticipated for 2022-2023 and zuclomiphene for 2022 [83]