- Revenue: $5.1 million for Q2 2024, up from $4.8 million in Q2 2023.
- Gross Profit: $0.4 million (9% of total revenue) for Q2 2024, down from $1.1 million (24% of total revenue) in Q2 2023.
- R&D Expenses: $1.9 million for Q2 2024, down from $2 million in Q2 2023.
- SG&A Expenses: $3 million for Q2 2024, down from $3.1 million in Q2 2023.
- Operating Loss: $4.5 million for Q2 2024, up from $4 million in Q2 2023.
- Net Loss: $6.3 million ($0.68 per share) for Q2 2024, compared to a net profit of $0.9 million ($0.1 per share) in Q2 2023.
- Non-GAAP Adjusted EBITDA: Loss of $3.4 million for Q2 2024, compared to a loss of $3 million in Q2 2023.
- Total Revenue (First Half 2024): $10 million, up from $8.6 million in the first half of 2023.
- Gross Profit (First Half 2024): $1.1 million (11% of total revenue), down from $2 million (23% of total revenue) in the first half of 2023.
- R&D Expenses (First Half 2024): $3.4 million, down from $4.1 million in the first half of 2023.
- SG&A Expenses (First Half 2024): $5.9 million, down from $6.2 million in the first half of 2023.
- Operating Loss (First Half 2024): $8.2 million, compared to $8.4 million in the first half of 2023.
- Net Loss (First Half 2024): $16 million ($1.73 per share), compared to $2.8 million ($0.32 per share) in the first half of 2023.
- Adjusted EBITDA (First Half 2024): Loss of $6.2 million, compared to a loss of $6.4 million in the first half of 2023.
- Cash and Cash Equivalents: $29.7 million as of June 30, 2024, compared to $42.1 million as of December 31, 2023.
Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Successfully completed the construction of a new state-of-the-art GMP compliant manufacturing facility for NexoBrid.
- Raised $25 million in financing, led by industry leader Monique, enhancing financial position.
- Received EUR16.25 million in funding for the expansion of EscharEx indication to include diabetic foot ulcers.
- Reported a 76% revenue growth for NexoBrid over the prior quarter, driven by increased hospital orders and patient treatments.
- Positive results from the United States NexoBrid expanded access protocol (NEXT program), reinforcing its clinical role in burn care.
Negative Points
- Gross profit decreased to $0.4 million, representing 9% of total revenue, compared to $1.1 million or 24% in the same period of 2023.
- Operating loss for the second quarter of 2024 was $4.5 million, compared to an operating loss of $4 million in the second quarter of 2023.
- Net loss for the quarter was $6.3 million or $0.68 per share, compared to a net profit of $0.9 million or $0.1 per share in the second quarter of 2023.
- Non-GAAP adjusted EBITDA for the second quarter of 2024 was a loss of $3.4 million, compared to a loss of $3 million in the same period of 2023.
- Cash and cash equivalents decreased to $29.7 million as of June 30, 2024, compared to $42.1 million as of December 31, 2023.
Q & A Highlights
Q: Can you provide more details on the next steps for increasing NexoBrid capacity and managing expectations from distributor partners in India, Japan, and Europe?
A: We have completed the construction of our new state-of-the-art manufacturing facility for NexoBrid. The commissioning process will begin soon and is expected to take about a year, including six months of stability testing. We anticipate European approval by May 2025 and U.S. approval by the end of 2025. This timeline reflects our execution plan to meet the growing demand.
Q: Could you explain the mechanics of the EUR16.25 million funding for the DFU trial and when the Phase 2/3 study might start?
A: The funding will be received in tranches, reimbursed quarterly based on expenses. We anticipate the first year will involve negotiations with regulatory authorities and setup activities. The trial, similar to our Phase 3 VLU study, will likely start in 2025 and take about two years to complete.
Q: Has the protocol for the EscharEx VLU pivotal study been submitted and approved by the FDA? What is the expected timeline for the interim analysis?
A: We are on track to initiate the trial in the second half of 2024. The protocol is about to be submitted for final FDA approval. The study will take around 18 months for recruitment, with an interim analysis after 66% of patients have completed the trial, providing early efficacy insights.
Q: What else is needed to get the new manufacturing facility into operational mode?
A: We need to start manufacturing at the new scale, which will take a few months. This includes producing several batches of NexoBrid and conducting six months of stability testing. After that, there will be a submission period of around six months.
Q: How will the EAP data be utilized for additional regulatory pathways or commercialization?
A: The EAP data will support our Phase 3 trial, which will be a global study involving 40 centers and 240 patients. This data reinforces the efficacy and safety of NexoBrid, aiding in regulatory submissions and commercialization efforts.
Q: How much of the DFU study costs will be covered by the EUR16.25 million funding, and will the $25 million raised from Monique cover the rest?
A: The EUR16.25 million funding is expected to fully cover the DFU study costs. The $25 million raised from Monique was not intended for this study but to support our broader strategic activities, including NexoBrid and the VLU study.
Q: Will you collaborate with the same partners for the DFU study as you did for the VLU study?
A: We anticipate collaborating with large players in the wound care field for the DFU study as well. The interest from global wound care companies in EscharEx is significant, and we will decide on the best partners as we move forward.
Q: How much inbound interest are you receiving for partnering or M&A related to EscharEx?
A: While we cannot comment on specific speculations, there is substantial interest from major advanced wound care companies in collaborating or gaining access to EscharEx. This interest underscores the potential and value of our technology.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
