Journey Medical (US:DERM)2022-08-10 12:06Financial Data and Key Metrics Changes - The company achieved net sales of $18.3 million, an increase of 20% compared to the second quarter of 2021, driven primarily by strong performance of QBREXZA and Accutane [9][15] - Net loss attributable to common shareholders was $7.5 million or $0.43 per share for the second quarter of 2022, compared to a net loss of $11.9 million or $1.30 per share for the same period in 2021 [19] - Non-GAAP adjusted EBITDA for the quarter was a loss of $2.6 million, with expectations of turning positive in upcoming quarters [20] Business Line Data and Key Metrics Changes - QBREXZA and Accutane achieved combined net sales of $11.3 million in the second quarter, representing a growth rate of 74% compared to the previous year [9] - Revenue from Targadox decreased by $3 million due to continued generic competition, while Ximino and Exelderm faced supply delays [16] Market Data and Key Metrics Changes - The market opportunity for DFD-29 is significant, with an estimated 16 million patients in the U.S. suffering from rosacea, equating to an estimated $1 billion in prescription sales in 2021 [12] - The Phase 2 clinical data for DFD-29 demonstrated nearly double the efficacy compared to the current market leader [12] Company Strategy and Development Direction - The company plans to continue executing its strategy of supporting and growing newly acquired and launched products, including QBREXZA, Accutane, AMZEEQ, and ZILXI [10][13] - Future growth is expected to be driven by the expansion of the product portfolio through in-licensing and acquiring commercial and late-stage development assets [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in recovering lost revenues due to supply chain delays and anticipates another year of record revenue growth [8] - The company is looking forward to achieving key milestones in the second half of 2022, including the completion of enrollment for Phase 3 clinical trials for DFD-29 [23] Other Important Information - The company had $38.1 million in cash and cash equivalents as of June 30, 2022, down from $49.1 million at the end of 2021 [21] - The company borrowed an additional $5 million from a term loan to support the DFD-29 clinical program and working capital [22] Q&A Session Summary Question: What do we need to see in the data to differentiate DFD-29 from others? - Management indicated that enrollment for the Phase 3 studies is on track, with expectations for significant improvement in inflammatory lesions and erythema as primary endpoints [25][27] Question: Can you comment on QBREXZA sales and specific campaigns? - Management highlighted a digital campaign focused on building awareness among the target demographic, resulting in a 25% increase in prescription growth from Q1 to Q2 [29][31] Question: What are the assumptions on placebo and active comparator in the studies? - Management provided efficacy estimates from the Phase 2 study, which were used for sample size calculations in the Phase 3 program [33] Question: At what stage will you provide longer-term projections and guidance? - Management indicated that guidance could be provided in the next two quarters, particularly as new assets are integrated [34][36] Question: How many sites are currently enrolled for the DFD-29 study? - Management reported 30 sites enrolled in the MVOR-01 study and 15 sites in the MVOR-02 study, with additional sites in Germany and Poland pending approval [37][38]