MediWound(MDWD) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported peak revenues of $20.7 million in Q2 2019, a significant increase from $1 million in Q2 2018, driven by a $17.5 million upfront license payment and $2.3 million from development services [27][31] - Gross profit for Q2 2019 was $17.3 million, compared to $0.4 million in Q2 2018, with the majority coming from license agreements [27] - The net profit for Q2 2019 was $12.7 million or $0.47 per share, while excluding the upfront license payment, the net loss was $3.3 million or $0.12 per share, an improvement from a net loss of $4.2 million or $0.15 per share in Q2 2018 [31][35] - Adjusted EBITDA for Q2 2019 was a profit of $15.4 million, compared to a loss of $2.9 million in the prior year [32] Business Line Data and Key Metrics Changes - NexoBrid achieved significant milestones, including positive Phase 3 results and a commercial agreement with Vericel, which is expected to maximize its commercial potential in North America [7][10] - The company launched a U.S. development plan for EscharEx, targeting chronic and hard-to-heal wounds, with plans for a Phase 2 study to begin in Q4 2019 [8][15] Market Data and Key Metrics Changes - BARDA committed an additional $21 million to support NexoBrid's development, particularly for the expanded access treatment protocol [12] - The company anticipates that the existing cash combined with proceeds from the Vericel collaboration will be sufficient to advance EscharEx development through BLA filing [37] Company Strategy and Development Direction - The company is focused on advancing NexoBrid towards BLA submission and developing EscharEx, which is seen as having significant market potential [24][38] - The strategy includes leveraging existing data from NexoBrid to derisk EscharEx development and enhance its market entry [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to bring NexoBrid to the U.S. market, highlighting the positive FDA meeting regarding the BLA submission plan [11][14] - The company expects to initiate the NEXT treatment protocol soon and file a BLA for NexoBrid in Q2 2020, while continuing to advance EscharEx [38] Other Important Information - The company had cash and equivalents of $38.7 million as of June 30, 2019, up from $23.6 million at the end of 2018 [36] - The CFO, Boaz Gur-Lavie, joined the company this quarter, bringing experience to support the company's growth [25] Q&A Session Summary Question: Timing on additional funding from BARDA for NexoBrid - Management confirmed a modified contract with BARDA providing an additional $21 million for regulatory submission and expanded access treatment protocol [42] Question: Potential acceleration of EscharEx study - Management indicated that if interim analysis shows strong safety and efficacy signals, the study could potentially be accelerated [43] Question: Filing of NexoBrid BLA with acute results or one-year results - Management plans to submit the BLA with the 12-month data for a better assessment by the FDA [48] Question: Expectations for BARDA procurement commitment - Management expects BARDA to initiate procurement in the first quarter of the following year, with the majority occurring next year [51] Question: Control of the NEXT study - The NEXT study is managed by MediWound with oversight from Vericel, focusing on burn centers with prior experience [54] Question: Logic behind the deal with Vericel - The partnership with Vericel was chosen to maximize NexoBrid's market potential while allowing MediWound to focus on developing EscharEx [62]