Axsome Therapeutics (AXSM) 2025 Conference September 04, 2025 01:00 PM ET Company ParticipantsPete Stavropoulos - Director - Biotech Equity ResearchMark Jacobson - COONick Pizzie - CFOPete StavropoulosHi, everybody. Yeah, so welcome to the Cantor Global Health Care Conference. I'm Pete Stavropoulos, a biotech analyst with Cantor. With us, we have Axsome Therapeutics, a company I cover. This is a name that the team I was on picked coverage on back in 2018. The day we launched coverage, the stock was trading ...

Axsome Therapeutics (AXSM) FY 2025 Conference September 03, 2025 03:45 PM ET Company ParticipantsMark Jacobson - COO & SecretaryNick Pizzie - CFOConference Call ParticipantsBenjamin Burnett - AnalystBenjamin BurnettOkay. Let's go ahead and get started with our next fireside chat. My name is Ben Burnett, biotech analyst at Wells Fargo. Pleased to be here with Nick Pizzi, CFO and Mark Jacobson, COO of Axsome.Mark JacobsonFor having us, Ben. I really appreciate it.Benjamin BurnettAwesome.Well, maybe just to ki ...

Axsome Therapeutics (AXSM) FY 2025 Conference September 03, 2025 03:45 PM ET Speaker0Okay. Let's go ahead and get started with our next fireside chat. My name is Ben Burnett, biotech analyst at Wells Fargo. Pleased to be here with Nick Pizzi, CFO and Mark Jacobson, COO of Axsome.Speaker1For having us, Ben. I really appreciate it. Awesome.Speaker0Well, maybe just to kick things off, maybe can you just kind of give a brief introduction of the company and kind of highlight any near term catalysts that we shoul ...

It has been about a month since the last earnings report for Axsome Therapeutics (AXSM) . Shares have added about 19.2% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Axsome due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Axsome Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late.Axso ...

Key Takeaways Axsome stock jumped 20.2% in a month, far outpacing its industry, sector and the S&P 500.Auvelity sales hit $215.9M in H1 2025, up 82.3% year over year, driving the company's top-line.Sunosi adds to AXSM's revenue momentum while new migraine drug Symbravo is likely to diversify the portfolio.Axsome Therapeutics (AXSM) delivered a strong performance over the past month, with its shares rallying 20.2% compared with the industry’s rise of 2.5%. The stock has also outperformed the sector and the S ...

Financial Performance - Axsome Therapeutics reported quarterly losses of 47 cents per share, significantly better than the analyst consensus estimate of losses of $1.07 per share [1] - The company achieved quarterly sales of $150.04 million, exceeding the analyst consensus estimate of $140.33 million [1] Company Commentary - The CEO of Axsome Therapeutics highlighted strong underlying demand for their medicines, effective commercial execution, solid regulatory progress, and advancements in their neuroscience pipeline [2] - The recent approval and launch of SYMBRAVO for migraine, along with the accelerating performance of AUVELITY for depression and SUNOSI for excessive daytime sleepiness, were noted as positive developments [2] Stock Performance and Analyst Ratings - Following the earnings announcement, Axsome Therapeutics shares fell by 3.4% to trade at $102.89 [3] - Analysts have adjusted their price targets for Axsome Therapeutics, with RBC Capital maintaining an Outperform rating and raising the price target from $184 to $189, and B of A Securities maintaining a Buy rating with a price target increase from $173 to $176 [5]

Core Insights - Axsome Therapeutics reported an adjusted loss of $0.97 per share in Q2 2025, which is an improvement from a loss of $1.67 per share in the same quarter last year and better than the Zacks Consensus Estimate of a loss of $1.00 [1][6] - The company's total revenues increased by 72% year over year to $150 million in Q2 2025, surpassing the Zacks Consensus Estimate of $140 million, primarily driven by strong sales of Auvelity [1][6] Revenue Breakdown - Total revenues for Q2 2025 included product revenues from Auvelity, Sunosi, and Symbravo, along with royalty revenues, with net product revenues reaching $148.9 million compared to $86.5 million in the previous year [3] - Auvelity sales amounted to $119.6 million, reflecting an 84% year-over-year increase and a 24% sequential increase, exceeding the model estimate of $111.8 million [4][6] - Sunosi's net product sales were $30 million in Q2 2025, up 35% from the previous year, with total prescriptions growing 13% year over year to 50,000 [7] Pipeline Developments - Axsome is planning several late-stage studies and regulatory filings for AXS-05, AXS-12, AXS-14, and solriamfetol, including a supplemental new drug application for AXS-05 targeting Alzheimer's disease agitation [6][11] - AXS-12 is being developed for narcolepsy, with plans to submit a new drug application for treating cataplexy in Q4 2025 [12] - The company is also evaluating solriamfetol in phase III studies for ADHD and MDD, with studies expected to start in Q4 2025 [14][15] Financial Overview - Research and development expenses were $49.5 million, down 0.8% from the previous year, while selling, general, and administrative expenses rose by 25.8% to $130.3 million due to increased commercial activities [9][10] - As of June 30, 2025, Axsome had cash and cash equivalents of $303 million, slightly up from $300.9 million at the end of Q1 2025 [10]

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) The company reported **$150.0 million** in Q2 2025 revenues, a narrowed net loss of **$48.0 million**, and increased total assets to **$639.8 million** after refinancing debt with a new **$570.0 million** Blackstone loan Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $303,016 | $315,353 | | Accounts receivable, net | $198,825 | $142,001 | | Total current assets | $536,620 | $485,064 | | Total assets | $639,785 | $568,498 | | **Liabilities & Equity** | | | | Total current liabilities | $342,099 | $230,104 | | Loan payable, long-term | $117,540 | $180,710 | | Total liabilities | $566,710 | $511,483 | | Total stockholders' equity | $73,075 | $57,015 | Consolidated Statement of Operations Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total revenues** | **$150,042** | **$87,166** | **$271,505** | **$162,165** | | Product sales, net | $148,959 | $86,520 | $269,317 | $160,616 | | Loss from operations | ($36,714) | ($78,046) | ($93,696) | ($145,321) | | **Net loss** | **($47,973)** | **($79,345)** | **($107,386)** | **($147,702)** | | Net loss per share | ($0.97) | ($1.67) | ($2.18) | ($3.11) | Consolidated Statement of Cash Flows Highlights (Six months ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($75,798) | ($83,577) | | Net cash used in investing activities | ($351) | ($150) | | Net cash provided by financing activities | $63,812 | $13,191 | | **Net decrease in cash** | **($12,337)** | **($70,536)** | - The company's product portfolio includes FDA-approved treatments Auvelity® (for major depressive disorder), Sunosi® (for narcolepsy/obstructive sleep apnea), and the newly approved Symbravo® (for migraine), which became commercially available in June 2025[23](index=23&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes improved financial performance to strong product sales and the Symbravo launch, with net loss decreasing to **$48.0 million** and liquidity enhanced by a new **$570.0 million** Blackstone loan facility Revenue by Product (in thousands) | Product | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Auvelity | $119,642 | $65,025 | $215,873 | $118,420 | | Sunosi | $28,907 | $21,495 | $53,034 | $42,196 | | Symbravo | $410 | $0 | $410 | $0 | | **Total Product Sales, net** | **$148,959** | **$86,520** | **$269,317** | **$160,616** | - The increase in net product sales was primarily due to higher unit sales volume for both Auvelity and Sunosi, along with the commercial launch of Symbravo in June 2025[199](index=199&type=chunk) - Selling, general and administrative (SG&A) expenses increased to **$130.3 million** in Q2 2025 from **$103.6 million** in Q2 2024, driven by higher commercial activities for Auvelity and Symbravo and increased personnel costs[204](index=204&type=chunk) - In May 2025, the company entered into a new loan agreement with Blackstone for up to **$570.0 million** and used the initial proceeds to repay its existing debt with Hercules Capital, resulting in a one-time loss on debt extinguishment of **$10.4 million**[109](index=109&type=chunk)[116](index=116&type=chunk)[235](index=235&type=chunk) - The company believes its current cash position is sufficient to fund anticipated operations into cash flow positivity based on its current operating plan[223](index=223&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=47&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company identifies interest rate fluctuations, foreign currency exchange, and inflation as principal market risks, none of which are currently expected to materially affect financial results - The company's principal market risks are limited to interest rate fluctuations, foreign currency exchange risk, and inflation[242](index=242&type=chunk)[243](index=243&type=chunk)[245](index=245&type=chunk) - Management does not believe an immediate 100 basis point increase in interest rates or a 10% change in foreign currency exchange rates would have a material effect on the company's financial results or cash flows[242](index=242&type=chunk)[244](index=244&type=chunk) [Item 4. Controls and Procedures](index=47&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report (June 30, 2025)[246](index=246&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected or are reasonably likely to materially affect internal controls[247](index=247&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=48&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is involved in ongoing legal proceedings, including a securities class action related to Symbravo® and patent infringement litigation concerning Sunosi® against generic drug manufacturers - **Securities Class Action:** A lawsuit alleging false statements regarding the NDA for AXS-07 (Symbravo®) is proceeding against the company and two officers after a motion to dismiss was partially denied in March 2025[251](index=251&type=chunk)[252](index=252&type=chunk) - **Shareholder Derivative Action:** A related derivative complaint against directors and officers is currently stayed pending the outcome of the Securities Class Action[253](index=253&type=chunk) - **Sunosi® Patent Litigation:** The company has filed patent infringement lawsuits against several generic drug manufacturers that submitted ANDAs for Sunosi®. Settlements have been reached with Unichem, Hikma, and Hetero, while actions against other defendants remain pending[254](index=254&type=chunk)[255](index=255&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant risks including a history of losses, the need for additional funding, dependence on product commercial success, regulatory uncertainties for pipeline candidates, competition, reliance on third parties, intellectual property challenges, and compliance with complex healthcare laws - **Financial Risks:** The company has a history of significant losses (**$1.23 billion** accumulated deficit as of June 30, 2025) and may never achieve profitability. It may need additional funding, and its debt agreement with Blackstone contains restrictive covenants[261](index=261&type=chunk)[266](index=266&type=chunk)[269](index=269&type=chunk) - **Commercial & Development Risks:** The business is substantially dependent on the success of its three commercial products. There is no guarantee that pipeline candidates (like AXS-05 for AD agitation, AXS-12, AXS-14) will receive regulatory approval or be successfully commercialized. The company faces significant competition from major pharmaceutical companies[285](index=285&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk) - **Third-Party & IP Risks:** The company relies on third parties for manufacturing, clinical trials, and other essential services. It also faces risks related to protecting its patents, potential infringement lawsuits, and the fact that some key intellectual property is licensed from an entity owned by its CEO[386](index=386&type=chunk)[393](index=393&type=chunk)[292](index=292&type=chunk) - **Regulatory & Legal Risks:** The company is subject to complex federal and state healthcare laws (e.g., Anti-Kickback, FCA), and failure to comply could result in substantial penalties. Changes in healthcare legislation, such as the Inflation Reduction Act (IRA), could adversely affect pricing and reimbursement[430](index=430&type=chunk)[446](index=446&type=chunk)[448](index=448&type=chunk) [Item 5. Other Information](index=112&type=section&id=ITEM%205.%20Other%20Information) The company did not adopt or terminate any Rule 10b5-1 trading arrangements, though two executive officers adopted new plans in June 2025 for future stock option exercises - The company did not adopt or terminate any Rule 10b5-1 trading arrangements for itself during Q2 2025[501](index=501&type=chunk) Executive Rule 10b5-1 Trading Plan Adoptions in Q2 2025 | Name | Title | Date of Adoption | Aggregate Shares to Be Sold | | :--- | :--- | :--- | :--- | | Herriot Tabuteau | Chief Executive Officer | June 13, 2025 | 524,000 | | Mark Jacobson | Chief Operating Officer | June 17, 2025 | 70,783 | [Item 6. Exhibits](index=112&type=section&id=ITEM%206.%20Exhibits) This section lists key exhibits filed with the Quarterly Report on Form 10-Q, including the Blackstone loan agreement, the 2025 Long-Term Incentive Plan, and standard CEO/CFO certifications - Key exhibits filed include the Loan Agreement with Blackstone dated May 8, 2025, and the company's 2025 Long-Term Incentive Plan documents[506](index=506&type=chunk)

Axsome Therapeutics (AXSM) reported $150.04 million in revenue for the quarter ended June 2025, representing a year-over-year increase of 72.1%. EPS of -$0.92 for the same period compares to -$1.24 a year ago. The reported revenue compares to the Zacks Consensus Estimate of $139.61 million, representing a surprise of +7.47%. The company delivered an EPS surprise of +8%, with the consensus EPS estimate being -$1.00. Shares of Axsome have returned -2.3% over the past month versus the Zacks S&P 500 composite's ...

Core Viewpoint - Axsome Therapeutics reported a quarterly loss of $0.92 per share, which was better than the Zacks Consensus Estimate of a loss of $1, indicating an earnings surprise of +8.00% [1] - The company has shown consistent performance by surpassing consensus EPS estimates for four consecutive quarters [2] Financial Performance - Axsome's revenues for the quarter ended June 2025 were $150.04 million, exceeding the Zacks Consensus Estimate by 7.47%, and representing a significant increase from $87.17 million in the same quarter last year [2] - The current consensus EPS estimate for the upcoming quarter is -$0.75 on revenues of $163.39 million, and for the current fiscal year, it is -$3.28 on revenues of $612.93 million [7] Stock Performance - Since the beginning of the year, Axsome shares have increased by approximately 21.8%, outperforming the S&P 500's gain of 6.1% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Axsome belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, which may impact stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]