Veru(US:VERU)2021-12-02 23:18Financial Data and Key Metrics Changes - The company achieved record net revenues of $61.3 million for fiscal year 2021, a 44% increase from $42.6 million in the prior year [66][73] - For Q4 2021, net revenues increased by 33% to $15.6 million from $11.7 million in the prior year [60] - Gross profit for Q4 was $12.3 million, representing 79% of net revenues, compared to $9.6 million or 81% in the prior year [61] - The company reported a net loss of $4.3 million or $0.05 per diluted share for Q4 2021, an improvement from a net loss of $11.8 million or $0.17 per diluted share in the prior year [65] Business Line Data and Key Metrics Changes - Revenue from the U.S. prescription business increased by 71% to $46.5 million from $27.1 million in the prior year [67] - The sexual health division, particularly the FC2 product, saw significant growth, with net revenues up 55% to $13.6 million in Q4 2021 [60][66] - The global public health sector business generated $13.9 million in net revenue for the fiscal year [66] Market Data and Key Metrics Changes - The company is focusing on large market opportunities in breast and prostate cancers, with ongoing clinical trials and product development [76][81] - The emergence of new COVID-19 variants has created a heightened demand for effective treatments, positioning the company’s drug sabizabulin as a potential solution for hospitalized patients [11][13] Company Strategy and Development Direction - The company is transitioning into a late-stage oncology biopharmaceutical firm, focusing on developing treatments for breast and prostate cancers [6][76] - The strategy includes leveraging revenues from the sexual health division to fund clinical development of oncology drug candidates [80] - Plans for fiscal year 2022 include conducting four late-stage clinical studies for metastatic breast cancer and advancing prostate cancer programs [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for fiscal year 2022, anticipating another record year driven by ongoing clinical programs and product launches [78][79] - The company is committed to addressing significant unmet medical needs in oncology while also pursuing opportunities in COVID-19 treatment [81] Other Important Information - The company has a strong cash position of $122.4 million as of September 30, 2021, which supports its clinical development initiatives [74] - The FDA has provided a safe to proceed letter for the Phase 2b study of sabizabulin, indicating no further hurdles before starting the study [85] Q&A Session Summary Question: What control arm is able to be dosed with for Sabizabulin in COVID studies? - The control arm allows for standard of care treatments such as dexamethasone and remdesivir, with patients randomized to either sabizabulin or placebo [92] Question: Are there any other hurdles to overcome before starting the Phase 2b study for Sabizabulin? - There are no other hurdles; the company is currently setting up the study and preparing for recruitment [85][90] Question: Is the Companion Diagnostic AR Test being developed for the ARTEST study? - The current test used is an AR CLIA test, with plans to transition to the commercial test developed by Roche Ventana during the ARTEST study [115][116]