For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Axsome Therapeutics Inc (NASDAQ:AXSM) reported strong revenue growth with total revenue of $171 million, a 63% increase year over year.
AUVELITY, a treatment for major depressive disorder, showed impressive growth with net product sales of $136.1 million, up 69% from the previous year.
The company successfully submitted a supplemental NDA for AXS-05 in Alzheimer's disease agitation, marking a significant milestone.
Axsome's R&D pipeline is robust, with multiple late-stage programs and two NDA stage programs expected to progress in the coming months.
The company ended the quarter with a strong cash position of $325.3 million, sufficient to fund operations into cash flow positivity.
Negative Points
Axsome Therapeutics Inc (NASDAQ:AXSM) reported a net loss of $47.2 million for the quarter, although this was an improvement from the previous year's loss.
The gross to net discounts for AUVELITY and SUNOSI are expected to increase in Q4, potentially impacting net revenue.
SYMBRAVO, despite being in its first full quarter on the market, generated only $2.1 million in net sales, indicating a slow start.
Research and development expenses decreased by 11%, which may suggest a slowdown in new clinical trial initiations.
The company anticipates elevated gross to net discounts for SYMBRAVO during its launch phase, which could affect profitability.
Q & A Highlights
Q: Can you discuss the early performance of SYMBRAVO and any plans for further investment in its launch? A: Ari Maizel, Executive Vice President - Head of Commercial, stated that the early response to SYMBRAVO has been positive, with a focus on penetrating top headache centers and large neurology practices. The company is pleased with the initial results and will consider further investment based on observed impacts and improvements in market access.
Q: How significant is the primary care segment for AUVELITY, and what strategies are in place to grow this segment? A: Ari Maizel explained that primary care is crucial for AUVELITY as many patients present to primary care offices for depression. The company has expanded its sales force to reach more primary care clinicians and launched a direct-to-consumer campaign to increase patient awareness and requests for the product.
Q: What are your expectations for AXS-05 adoption in Alzheimer's agitation, and how will you drive uptake? A: Ari Maizel highlighted the overlap between Alzheimer's agitation and major depressive disorder prescribers, allowing the existing sales force to promote AXS-05 efficiently. The company plans to invest in long-term care promotion and leverage learnings from other successful launches to ensure uptake.
Q: Can you provide insights into the sales force capacity and future expansion plans? A: Ari Maizel mentioned that the current sales force is effectively driving growth, but there are plans to expand in support of Alzheimer's agitation approval. Nick Pizzie, CFO, added that the SG&A increase was due to the direct-to-consumer campaign and SYMBRAVO commercialization, with no changes to the cash flow positivity outlook.
Q: What is the status of the AXS-05 application for Alzheimer's agitation, and are there any impacts from the government shutdown? A: Ari Maizel stated that the company has not disclosed the submission date but expects an FDA decision on acceptance soon. There are no anticipated impacts from the government shutdown on the application process.
Q: How do you view the long-term strategic perspective of your portfolio, and are you considering adding new assets? A: Herriot Tabuteau, CEO, emphasized that the company is in a strong position with three marketed products and a robust pipeline. While there is no immediate need to add new assets, Axsome is open to complementary opportunities that align with strategic goals.
Q: What are your thoughts on the competitive landscape for reboxetine and its commercial opportunity? A: Herriot Tabuteau expressed excitement about reboxetine's focus on reuptake inhibition and its potential to address unmet needs in the sleep space. The company sees high synergy with existing sales and marketing infrastructure, particularly for SUNOSI.
Q: How do you plan to address the long-term care market for AXS-05 in Alzheimer's agitation? A: Ari Maizel explained that long-term care requires a different approach, focusing on nursing staff, pharmacy directors, and medical directors. The company plans to have a dedicated team for long-term care facilities if AXS-05 is approved.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
https://finance.yahoo.com/news/axsome-therapeutics-inc-axsm-q3-190134565.html
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