MediWound(MDWD) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenues for Q2 2021 increased 50% to $6.1 million compared to $4 million in Q2 2020 [23] - Product revenue for Q2 2021 was $3 million, a 175% increase from $1.1 million in Q2 2020, driven by BARDA procurement of NexoBrid [23] - Gross profit for Q2 2021 was $2.4 million or 39% of net revenue, compared to $1.2 million or 30% in Q2 2020 [24] - Net loss for Q2 2021 was $3.2 million or $0.12 per share, compared to a net loss of $3.1 million or $0.11 per share in Q2 2020 [25] - For the first half of 2021, revenue increased 41% to $11.9 million compared to $8.5 million in the first half of 2020 [26] Business Line Data and Key Metrics Changes - The EscharEx clinical development program showed positive interim assessment results, confirming no need for sample size adjustments [12] - NexoBrid's commercial growth is supported by BARDA procurement, with expectations to recognize most remaining revenues in 2021 [17] - The company continues to enroll patients in the expanded access program for NexoBrid, with over 100 burn victims treated to date [17] Market Data and Key Metrics Changes - The company is executing a global expansion strategy, expecting additional marketing approvals in lucrative markets over the next 18 months [17] - The pediatric investigational plan for NexoBrid showed positive top-line results from a Phase III study, reinforcing its clinical safety and efficacy profile [19] Company Strategy and Development Direction - The company aims to enhance global expansion and expects additional marketing approvals in new territories throughout 2022 [22] - MediWound is committed to bringing NexoBrid to the U.S. market as quickly as possible, addressing FDA concerns from the CRL [18] - The company is focused on advancing its clinical development programs, particularly for EscharEx and NexoBrid, while maintaining budget discipline [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term potential of NexoBrid and the prospects for EscharEx, highlighting a diversified pipeline [29] - The company is monitoring the impact of COVID-19 dynamics on its financial guidance for 2021 [28] Other Important Information - As of June 30, 2021, the company had $17.2 million in cash and short-term investments, down from $21.6 million at the end of 2020 [28] - The company plans to complete enrollment in the EscharEx Phase II study by the end of 2021, with data readout anticipated in the first half of 2022 [13] Q&A Session Summary Question: Update on regulatory process for NexoBrid in the U.S. - Management believes FDA concerns can be addressed without additional studies and is preparing for a Type A meeting with the FDA [30] Question: Regulatory strategy for pediatric population regarding NexoBrid - Any label extension in the U.S. will follow approval for the adult indication, leveraging pediatric data in the resubmission [31] Question: Update on expanded access protocol for NexoBrid - Currently, there are 21 active sites in the U.S., with plans to extend to up to 30 sites and treat at least 200 patients [34] Question: MediWound's role in BLA resubmission for NexoBrid - The collaboration with Vericel and BARDA is crucial, with Vericel taking a leadership role in the regulatory process [37] Question: Timing for starting the second pivotal trial for EscharEx - Enrollment for the ongoing Phase II study is expected to be completed by year-end, with data readout anticipated in the first half of 2022 [39]