Revance(RVNC) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2019 with cash, cash equivalents, and short-term investments of $209 million, excluding a $5 million milestone payment from Mylan expected in Q4 2019 [18] - Revenue for Q3 2019 was $46,000 from the Mylan collaboration, with operating expenses of $42.6 million, and non-GAAP operating expenses of $37.5 million [19][20] - The company maintained its 2019 guidance, expecting GAAP operating expenses between $173 million and $185 million [20] Business Line Data and Key Metrics Changes - The company is focused on the commercialization of DaxibotulinumtoxinA (DAXI) in the aesthetic market and has plans for a Biologics License Application (BLA) submission by the end of November 2019 [10][12] - DAXI is positioned as a long-acting neuromodulator, with clinical trials showing exceptional response rates and a long duration of effect [11][17] Market Data and Key Metrics Changes - The global therapeutic market is valued at $2.5 billion, with DAXI expected to capture significant market share due to its differentiated long-acting profile [15][38] - The U.S. facial aesthetics market is described as a billion-dollar market, with DAXI targeting the majority of neuromodulator use in facial lines [14] Company Strategy and Development Direction - The company aims to successfully launch DAXI in the aesthetics market while unlocking value in the therapeutic space [27] - The management emphasizes the importance of capital allocation and market research to inform their launch strategy [27] - The company is exploring additional therapeutic indications beyond cervical dystonia, including migraine and upper limb spasticity [39] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming BLA submission and the potential approval and launch of DAXI in the second half of 2020 [23] - The company is optimistic about the long-term value of DAXI in both aesthetic and therapeutic markets, highlighting its unique position as the first true innovation in the neuromodulator market in over 30 years [11][12] Other Important Information - The company has made significant progress in its clinical trials, completing enrollment in multiple studies and preparing for data readouts in 2020 [17] - The management team has been strengthened with key hires in the commercial organization to support the launch of DAXI [13][67] Q&A Session Summary Question: Any specific strategic initiatives or plans evolving from the new CEO's perspective? - The CEO indicated no material changes in strategy, focusing on a successful launch in aesthetics and unlocking value in therapeutics [27] Question: What are the chances of DAXI's performance facilitating additional movement disorder indications? - The CEO stated that cervical dystonia will be the first indication, and future submissions will depend on data from ongoing trials [29] Question: How does the company view pricing in the competitive landscape? - The CEO believes DAXI's long duration will allow for premium pricing, differentiating it from short-acting competitors [35] Question: What therapeutic areas are being considered for further exploration? - The CEO confirmed a focus on existing therapeutic categories, with migraine being a significant market of interest [39] Question: What share does the company expect to capture in the market? - The CEO mentioned that over 50% of consumers indicated that a long-acting neuromodulator would influence their decision-making [42] Question: What is the status of the Mylan biosimilar program? - The CEO noted that Mylan has contributed $30 million to the program, with a decision expected by April 2020 [42][49] Question: Will there be updates on the migraine program? - The CEO indicated that trials for the migraine program could potentially start in 2020, but no specific timeline was provided [53] Question: How does the company plan to approach international filings for DAXI? - The COO stated that international filings would begin approximately six months after the U.S. filing [48] Question: What is the company's strategy regarding potential partnerships for international markets? - The CEO mentioned that they are open to out-licensing rights and exploring partnerships for both therapeutic and aesthetic markets [69]