Veru(US:VERU)2021-02-10 21:17Financial Data and Key Metrics Changes - The company reported a record net revenue of $14.6 million for Q1 fiscal year 2021, up 38% from $10.6 million in the prior-year quarter [38] - Gross profit increased to $10.8 million, representing 74% of net revenues, compared to $7.3 million or 69% in the prior year [38] - Operating income for the quarter was $19.2 million, a significant increase from an operating loss of $1.8 million in the prior year, primarily due to an $18.4 million gain on the sale of the PREBOOST business [39] - Net income was $17.2 million or $0.023 per diluted share, compared to a net loss of $3.3 million or $0.05 per diluted share in the prior year [40] Business Line Data and Key Metrics Changes - The US FC2 prescription business generated net revenues of $9.1 million in Q1 fiscal year 2021, up 50% from $6.1 million in Q1 fiscal year 2020 [8] - The public sector business saw an increase in net revenues to $4.7 million from $4.4 million in the prior year quarter [38] - The PREBOOST business generated $863,000 in revenues through the sale date, compared to $153,000 in the prior year quarter [38] Market Data and Key Metrics Changes - The company anticipates launching TADFIN, a combination capsule for treating lower urinary tract infections, with an NDA submission expected soon [10] - The company is focused on developing oral therapies for advanced prostate and breast cancers, with plans for multiple registration clinical trials in 2021 [10][11] Company Strategy and Development Direction - The company aims to transform into a late clinical-stage oncology biopharmaceutical company, focusing on novel medicines for prostate and breast cancers [42] - The company plans to leverage cash generated from its sexual health business to fund clinical development of oncology drug candidates [7][45] - The company is committed to advancing Veru-111 into a Phase 3 clinical study for COVID-19, despite it not being the primary focus [36][45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued growth trajectory of the sexual health business, which supports the funding of clinical trials [41] - The company expects another record year in fiscal year 2021, with potential options to monetize its business further [45] - Management highlighted the importance of Veru-111 as a broad-spectrum antiviral and anti-inflammatory agent in the context of the ongoing COVID-19 pandemic [36][56] Other Important Information - The company has sufficient resources to fund all planned registration clinical trials, with a cash balance of $30.9 million as of December 31, 2020 [40][41] - The company received a waiver for the FDA PDUFA fees for the NDA submission of TADFIN, amounting to approximately $2.4 million [9] Q&A Session Summary Question: Can you help us think about Veru-111's position in the market? - Management explained that Veru-111 disrupts the microtubule trafficking system, making it a broad-spectrum antiviral, and they are prepared to collect data on mutant strains during the Phase 3 trial [50][51] Question: Was the record quarter primarily driven by US prescription sales? - Management confirmed that the record quarter was primarily driven by US prescription sales, which increased by 50% [61] Question: What are the expectations for TADFIN sales once launched? - Management indicated uncertainty regarding TADFIN sales but noted the potential for significant market reach through telemedicine [63] Question: When can we expect top-line results from the Phase 2 trial of Veru-111 in prostate cancer? - Management did not provide a specific timeline for the Phase 2 trial results but emphasized the importance of the data for the Phase 3 trial [65]