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Monday, November 3, 2025

Axsome Therapeutics Inc (AXSM) Q3 2025 Earnings Call Highlights: Robust Revenue Growth

 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

Revolution Medicines a new outperform at RBC

  on RAS(ON) inhibitors for cancers

https://seekingalpha.com/news/4513496-revolution-medicines-new-outperform-rbc-ras-on-inhibitors-cancers

EXEL Downgraded to Neutral by Guggenheim

 On November 3, 2025, Exelixis (EXEL) received a downgrade from Guggenheim, with analyst Michael W. Schmidt changing the rating from Buy to Neutral. The report did not provide a specific price target for EXEL in this latest adjustment.

https://www.gurufocus.com/news/3178655/exel-downgraded-to-neutral-by-guggenheim-on-november-3-2025-exel-stock-news

Over $1 Billion in Medicaid Funds Spent on Illegal Immigrants: Audit

 An audit conducted by the Centers for Medicare & Medicaid Services (CMS) found that more than $1 billion in Medicaid funds have been spent on illegal immigrants, despite a prohibition in federal law.

California alone spent $1.3 billion in Medicaid funds in 2024 and 2025 to cover health care for immigrants illegally in the country, according to the preliminary audit released Friday. Four other states and the District of Columbia also spent funds from Medicaid on illegal immigrants during that time frame.

“Protecting Medicaid from waste, fraud, and abuse isn’t optional—it’s the law. Every dollar misspent on illegal health care spending is a dollar taken from vulnerable Americans,” a spokesperson for the Department of Health and Human Services, the parent agency of CMS, told The Epoch Times in an email on Oct. 31.

“Federal law forbids using Medicaid funds for illegal immigrants, yet several Democrat-led states did it anyway,” the spokesperson continued. “The Trump Administration won’t tolerate it. CMS is auditing aggressively, recovering every dollar, and holding states accountable.”

According to the audit, from 2024 to 2025, Illinois spent $29 million on health care for illegal immigrants, Oregon spent $5.4 million, the District of Columbia and Washington state spent $2 million, and Colorado spent $1.5 million.

The states and the District of Columbia did not respond to requests for comment.

Medicaid provides health care to about 78 million Americans, a number of whom are low income. Federal law makes the program available for U.S. citizens and certain immigrants, such as refugees, who have legal status.

The only exceptions are for services for emergency medical conditions for illegal immigrants who meet other eligibility requirements and for some immigrant children and pregnant women who are not otherwise able to receive Medicaid, such as people protected under Deferred Action for Childhood Arrivals.

In August, a federal judge blocked CMS from sharing data on Medicaid recipients with the Department of Homeland Security, which handles immigration enforcement.

Health officials later announced they would be looking to make sure that people were not improperly enrolled in Medicaid or the Children’s Health Insurance Program, which provides health insurance at reduced costs to some children and pregnant women.

CMS said it will begin giving states monthly updates regarding people who could not be verified as citizens or legal immigrants through federal databases.

“Medicaid is a lifeline for vulnerable Americans—and I will protect it from abuse,” Health Secretary Robert F. Kennedy Jr. said. “We are tightening oversight of enrollment to safeguard taxpayer dollars and guarantee that these vital programs serve only those who are truly eligible under the law.”

In recent days, Deputy Health Secretary Jim O'Neill posted to X pictures of individuals he says have been receiving Medicaid despite being illegal immigrants, including immigrants convicted of murder and sex offenses.

That includes a 53-year-old Cuban national who was convicted of murder, O'Neill wrote on Friday, who received $1,537 through Medicaid.

AARP’s 'Affordability' Hypocrisy

 When evaluating an advocacy group’s views on public policy, it helps to consider the source. In the case of AARP, that means scrutinizing the sizable conflicts of interest that compromise the organization’s policy positions. Even as it lobbies for a permanent extension of enhanced Obamacare subsidies to make insurance “affordable,” AARP funds that lobbying by making health coverage less affordable for its own members.

A glance at AARP’s most recent financial statements shows a glaring conflict. Last year, the organization received $9.1 billion—that’s billion with a “B”—from its restructured contract with UnitedHealth. The one-time, tax-free payment constituted an advance on future royalties from selling UnitedHealth insurance policies.

As I have outlined in a series of reports for American Commitment, AARP has become increasingly dependent upon royalty revenue, and specifically revenue from UnitedHealth, to sustain its operations. From 2007 through 2024, AARP received $15.5 billion in royalty fees, of which an estimated $10.8 billion came from UnitedHealth. In 2024, I estimate that revenue from UnitedHealth comprised nearly half (47.9%) of AARP’s income.

Yet AARP says precious little about how its revenue sources compromise its policy positions. In lobbying Congress and issuing fact sheets about the Exchange subsidies, it included not a word about how a large and growing portion of its revenue base comes directly from the nation’s largest health insurer. UnitedHealth has an obvious financial stake in keeping the enhanced Obamacare subsidies flowing—and its reliance on revenue from UnitedHealth means that AARP does too.

For an entity that advocates for transparency regarding drug pricing, AARP seems intent on ignoring the conflicts posed by its relationship with UnitedHealth. Its website mentions not a word about the federal investigation surrounding UnitedHealth’s Medicare billing practices. An AARP article about last year’s ransomware attack on a UnitedHealth affiliate, which crippled the health care system for months, failed to reference AARP’s ongoing contractual arrangement with UnitedHealth. AARP even went so far as to reword its financial statements to prevent readers from determining the precise amount of revenue it receives from UnitedHealth each year, months after I published an expose pointing out that AARP had made billions from that relationship.

But the larger irony comes from AARP’s position on Obamacare subsidies. For all its talk about “affordability,” AARP receives “royalties” generated by overcharging seniors for insurance. For its Medicare supplemental plans sold via UnitedHealth, AARP receives a “royalty fee” that amounts to 5.95% of every premium dollar—a percentage-based structure that gives AARP a clear financial incentive to sell seniors coverage they may not need or want, just to benefit its own bottom line. AARP would have slightly more credibility lecturing Congress on insurance “affordability” if its entire business model didn’t center on making health insurance less affordable for its own members.

In the past, AARP executives have dismissed these inherent financial conflicts by claiming that they would gladly forego revenue to fix the health care system. But the amount of revenue it receives from UnitedHealth means that AARP cannot forfeit that income without jeopardizing its financial viability, demonstrating how badly compromised the organization has become.

If AARP cares so much about affordability for seniors, it has a simple solution staring it in the face—one which won’t involve a taxpayer-funded bailout of its partners at UnitedHealth. AARP can, and should, stop overcharging its members for insurance, and figure out another way to generate revenue—preferably one in which the organization’s actions actually align with its stated policy positions.

Chris Jacobs is Founder and CEO of Juniper Research Group, and author of the book The Case Against Single Payer

https://www.realclearhealth.com/articles/2025/11/03/aarps_affordability_hypocrisy_1144963.html