Revance(US:RVNC)2021-11-10 13:54Financial Data and Key Metrics Changes - Total revenue for Q3 2021 was $19.7 million, which included $18.3 million from the RHA Collection, $1.1 million from the partnership with Viatris on the biosimilar to BOTOX, and $0.3 million from the fintech platform [33] - Selling, general and administrative expenses for Q3 were $52.8 million, with non-GAAP SG&A expenses at $45.1 million [34] - Research and development expenses were $30.1 million for Q3, with non-GAAP R&D expenses at $25.7 million [35] - Cash, cash equivalents, and short-term investments as of September 30, 2021, were $273.7 million [36] Business Line Data and Key Metrics Changes - RHA revenue for Q3 was $18.3 million, a 7.4% increase over Q2, driven by higher sales from existing accounts and the addition of new accounts [21] - The RHA Collection has been positioned as the most natural and least modified hyaluronic acid dermal filler on the market, with over 2,500 aesthetic accounts established [22] - OPUL maintained a payment processing volume run rate of over $0.5 billion despite a traditionally slower season [25] Market Data and Key Metrics Changes - The muscle movement disorder market opportunity currently stands at $1.2 billion worldwide, with approximately 78% of that opportunity in the U.S. [12] - The overall market for facial injectables remains robust, with expectations for a seasonally strong Q4 heading into the holiday season [21][61] Company Strategy and Development Direction - The top strategic priority is to obtain FDA approval for DaxibotulinumtoxinA for Injection for glabellar lines as soon as possible [14] - The company aims to increase revenue in the $1.2 billion U.S. dermal filler market with the RHA Collection and expand customer relationships through OPUL [14] - Organizational changes were announced to streamline operations and enhance performance, including the promotion of Dustin Sjuts to President [16] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment regarding the CRL received from the FDA but remains determined to achieve product approval [7][9] - The company believes the deficiencies cited in the CRL were limited to manufacturing facility observations and not related to clinical data [13] - Management is focused on preserving cash to enhance financial flexibility while continuing to build the business long-term [41] Other Important Information - The company plans to provide updated cash guidance following the Type A meeting with the FDA [40] - The ASPEN-OLS study for cervical dystonia demonstrated that DaxibotulinumtoxinA for Injection was generally safe and well-tolerated [28] Q&A Session Summary Question: Clarity on the CRL and consulting efforts - Management indicated that the Establishment Inspection Report provided additional clarity and comfort regarding the responses to the FDA [46] - The company continues to leverage external experts to navigate the approval process [49] Question: Impact of the pandemic on FDA inspection timing - Management stated that it is speculative to comment on pandemic-related issues affecting timing, with clarity expected after the Type A meeting [55] Question: Trajectory for RHA fillers and account expansion - Management expressed confidence in the ongoing growth of RHA and the potential to increase account penetration, despite the absence of DaxibotulinumtoxinA [61][63] Question: Update on the partnership with TEOXANE - The relationship with TEOXANE remains strong, with no adverse impacts from the stock performance related to the CRL [100]