Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Pulse Biosciences Inc (PLSE, Financial) has made significant progress in early commercialization steps for their percutaneous electrode for soft tissue ablation in benign thyroid diseases.
- The company has received seven FDA clearances and treated 6,000 patients, showcasing a mature platform ready for multiple clinical and regulatory initiatives.
- Pulse Biosciences Inc (PLSE) strengthened its balance sheet by raising $47.9 million in net proceeds through the exercise of warrants.
- The company has a robust portfolio of over 180 issued patents, protecting its unique nanosecond PFA technology.
- Pulse Biosciences Inc (PLSE) has appointed new leadership, including a new CFO and Chief Medical Officer, to drive its strategic initiatives forward.
Negative Points
- The company reported a GAAP net loss of $19.4 million in the fourth quarter of 2024, compared to $11.9 million in the prior year period.
- Total GAAP costs and expenses increased significantly by $7.7 million to $20.3 million, driven by higher non-cash stock-based compensation and other administrative expenses.
- Non-GAAP net loss also increased to $10.4 million in the fourth quarter of 2024, compared to $8.3 million in the prior year period.
- Cash used in the fourth quarter of 2024, excluding net proceeds from financing, totaled $9.3 million, indicating higher operational cash burn.
- The company faces the challenge of scaling its commercial operations and achieving reimbursement for its novel therapies in competitive markets.
Q & A Highlights
Q: What are the key highlights of Pulse Biosciences' recent progress and future plans?
A: Paul Laviolette, CEO, highlighted the company's advancements in early commercialization of their percutaneous electrode for benign thyroid diseases, clinical feasibility studies for atrial fibrillation, and the launch of their soft tissue ablation product in the US. The company aims to advance commercialization and initiate pivotal studies for their cardiac devices in 2025.
Q: Can you elaborate on the potential of nanosecond PFA technology?
A: Laviolette explained that nanosecond PFA offers benefits over microsecond PFA, such as non-thermal ablation, faster treatment times, and deeper lesions with lower energy. This technology is expected to improve patient outcomes across various medical conditions and is seen as a platform technology for multiple clinical applications.
Q: What are the financial highlights for the fourth quarter of 2024?
A: Jon Skinner, CFO, reported that GAAP costs and expenses increased to $20.3 million, primarily due to higher non-cash stock-based compensation. The company raised $47.9 million through warrant exercises, ending the year with $118 million in cash and equivalents.
Q: How is Pulse Biosciences planning to approach market entry for its products?
A: The company plans to implement a hybrid business model, either building a direct commercial team or partnering with market leaders, depending on the market's complexity and competition. This approach aims to efficiently bring nanosecond PFA to patients while managing commercialization challenges.
Q: What are the next steps for the company's cardiac surgical clamp and 360 catheter system?
A: The company is conducting feasibility studies for the cardiac surgical clamp in Europe and plans to submit an IDE to the FDA for a pivotal trial. For the 360 catheter system, they are continuing enrollment in feasibility studies and aim to disrupt the AF treatment landscape with their differentiated technology.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
