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Axsome Therapeutics, Inc. (AXSM) is a commercial-stage biopharmaceutical company specializing in developing and delivering innovative therapies for central nervous system (CNS) disorders. The company focuses on addressing unmet medical needs with limited treatment options, offering FDA-approved products and a robust pipeline of candidates targeting various CNS conditions. Axsome's portfolio includes treatments for major depressive disorder, excessive daytime sleepiness, and migraines, among others.
- Auvelity - Treats major depressive disorder in adults, utilizing a novel mechanism of action for rapid and sustained antidepressant effects.
- Sunosi - Improves wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea; also generates royalty revenue from ex-U.S. markets.
- Symbravo - Provides acute treatment for migraines with or without aura in adults, recently approved by the FDA.
- Pipeline Products - Includes candidates such as AXS-05 for Alzheimer’s agitation and smoking cessation, AXS-07 for migraines, AXS-12 for narcolepsy, AXS-14 for fibromyalgia, and solriamfetol for ADHD.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Herriot Tabuteau ExecutiveBoard | Founder, Chief Executive Officer, President, and Chairman of the Board | Founder and Managing Member of Antecip Capital LLC; Managing Member of Antecip Bioventures II LLC | Herriot Tabuteau has been serving as the CEO and primary leader of Axsome Therapeutics since January 2012. He has a strong background in biotechnology investing and analysis, previously founding and managing Antecip Capital LLC and Antecip Bioventures II LLC. | View Report → |
Ari Maizel Executive | Chief Commercial Officer | Ari Maizel is the Chief Commercial Officer at Axsome Therapeutics since his promotion in October 2024. He joined the company as Executive Vice President, Head of Commercial in September 2023 and has extensive experience in pharmaceutical sales, marketing, and strategy. | ||
Hunter Murdock Executive | General Counsel | Hunter Murdock, Esq. has been serving as General Counsel at Axsome Therapeutics since June 2022. He previously served as Executive Vice President, Legal and Compliance starting in December 2021. | ||
Lori Englebert Executive | Executive Vice President, Product Strategy | Lori Englebert is the Executive Vice President, Product Strategy at Axsome Therapeutics, a role she has held since October 2023 after joining the management team in September 2019. She has contributed significantly to Axsome's commercial strategy and has a robust background from her previous leadership roles in companies like Amgen and Novartis. | ||
Mark Jacobson Executive | Chief Operating Officer | Mark Jacobson is the Chief Operating Officer of Axsome Therapeutics since March 2020, previously serving as Senior Vice President, Operations from September 2017, and has been with the company since April 2014. | ||
Nick Pizzie Executive | Chief Financial Officer | Nick Pizzie, C.P.A., M.B.A., has served as the Chief Financial Officer at Axsome Therapeutics, Inc. since May 2018, overseeing the company’s financial operations. He previously held the role of CFO at Pierre Fabre USA from 2013 to 2018, and has held senior roles at Immucor, Merck, Pfizer, and Arthur Andersen. |
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Given the net loss of $287.2 million in 2024 despite total product revenues of $385.7 million, can you provide more detail on when you expect to achieve cash flow positivity and what specific measures are being taken to reduce expenses and improve margins?
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With the upcoming NDA submissions for AXS-05 in Alzheimer's disease agitation and AXS-12 in narcolepsy, can you clarify the potential regulatory challenges and how you plan to address any concerns from the FDA, especially considering you haven't finalized the filing approach for AXS-05?
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Considering the high rebate environment in the acute migraine market and strong competition from oral CGRP inhibitors, how do you plan to position and price Symbravo to gain market share without significantly impacting net price and margins?
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There has been mixed feedback from key opinion leaders regarding AXS-12 for narcolepsy due to its mechanism as an SNRI; how do you plan to differentiate AXS-12 in the market and overcome potential skepticism from prescribers?
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Can you provide more transparency on your operating expenses, especially with the upcoming launches and sales force expansions, and how these expenses will impact your path to profitability over the next few years?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The company markets Prozac, a branded antidepressant, and Reyvow, a treatment for acute migraine. Prozac is used for major depressive disorder, while Reyvow is part of the competitive landscape for migraine treatments. | |
The company markets Zoloft and Effexor for depression, Chantix for smoking cessation, and Nurtec for migraines. These products compete in various therapeutic areas relevant to the company's pipeline. | |
Takeda Pharmaceuticals America, Inc. | The company markets Trintellix for depression and is developing compounds for narcolepsy symptoms. |
H. Lundbeck A/S | The company co-markets Rexulti with Otsuka Pharmaceutical Co., Ltd. for depression and is involved in migraine treatment development. |
Otsuka Pharmaceutical Co., Ltd. | The company co-markets Rexulti with Lundbeck for depression and is developing treatments for agitation associated with Alzheimer's disease. |
The company markets Vraylar and Viibryd for depression and Ubrelvy for migraines. These products compete in CNS therapeutic areas. | |
The company markets Wellbutrin for depression and Zyban for smoking cessation. | |
The company markets Xyrem and Xywav for excessive daytime sleepiness associated with narcolepsy. | |
Harmony Biosciences LLC | The company markets Wakix for excessive daytime sleepiness associated with narcolepsy. |
The company markets Lumryz for excessive daytime sleepiness associated with narcolepsy. | |
The company manufactures Provigil and Nuvigil for excessive daytime sleepiness associated with narcolepsy. | |
The company is developing compounds for depression and migraine treatment. | |
The company is developing compounds for depression and agitation associated with Alzheimer's disease. | |
The company is developing compounds for depression treatment. | |
The company is developing compounds for depression treatment. | |
The company is developing compounds for depression and agitation associated with Alzheimer's disease. | |
The company is developing compounds for agitation associated with Alzheimer's disease. | |
The company is developing compounds for agitation associated with Alzheimer's disease. | |
The company markets Maxalt for acute migraine treatment. | |
Pernix Therapeutics Holdings, Inc. | The company markets Treximet for acute migraine treatment. |
Impel Pharmaceuticals | The company markets Trudhesa for acute migraine treatment. |
The company is developing compounds for narcolepsy symptoms. | |
Eisai Co., Ltd. | The company is developing compounds for narcolepsy symptoms. |
The company is developing compounds for narcolepsy symptoms. | |
Dogwood Therapeutics, Inc. | The company is developing therapeutics for fibromyalgia. |
The company is developing therapeutics for fibromyalgia. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Sunosi assets (acquired from Jazz Pharmaceuticals) | 2022 | Axsome Therapeutics executed an Asset Purchase Agreement on March 25, 2022, to acquire the Sunosi assets, including worldwide commercial, development, manufacturing, and IP rights (excluding certain Asian markets) with an upfront payment of $53 million plus $36.14 million contingent consideration, and established royalty terms and milestone commitments. The deal was financed via Axsome's $300 million term loan facility, incurred $0.5 million in transaction costs, and featured a two-closing structure with the initial U.S. closing on May 9, 2022. |
Recent press releases and 8-K filings for AXSM.
- Axsome Therapeutics reported topline results from its PARADIGM Phase 3 proof-of-concept trial evaluating solriamfetol in patients with Major Depressive Disorder (MDD) with and without severe Excessive Daytime Sleepiness (EDS).
- The trial, conducted over a 6-week period with a randomized, double-blind, placebo-controlled design, did not meet its primary endpoint in the overall patient population.
- In the prespecified subgroup of patients with severe EDS, solriamfetol showed greater improvements in depressive symptoms, supporting the decision to plan a Phase 3 trial focusing on MDD with EDS in 2025.
- FOCUS Phase 3 trial in adults with ADHD met its primary endpoint by demonstrating a statistically significant improvement in AISRS total score (mean reduction of 45% from baseline) and achieved the key secondary endpoint on CGI-S.
- The trial was a 6-week, randomized, double-blind, placebo-controlled study involving 516 participants across multiple centers, showing solriamfetol 150 mg provided marked efficacy with a favorable safety profile.
- Axsome Therapeutics has reached a settlement agreement with Hikma Pharmaceuticals USA regarding patent litigation over its product Sunosi® (solriamfetol), resolving disputes over a generic application submitted by Hikma.
- Under the settlement, Hikma is granted a license to market a generic version of Sunosi beginning on or after September 1, 2040 if pediatric exclusivity is granted, or on or after March 1, 2040 if not, subject to FDA approval and standard conditions.
- The litigation was pending in the U.S. District Court for the District of New Jersey and similar litigation with other parties remains active.
- Axsome Therapeutics received formal FDA pre-NDA meeting minutes supporting its planned supplemental NDA submission for AXS-05 in Alzheimer's disease agitation, confirming that the clinical and nonclinical data package is sufficient for the filing.
- The company anticipates submitting the sNDA in Q3 2025, aiming for priority review to address the significant unmet medical need in Alzheimer's disease agitation.
- Robust Q4 Revenue Performance: Net product revenue reached $118.8M , driven by strong contributions from Auvelity ($92.6M, 124% growth ) and Sunosi ($26.2M, 26% growth ).
- Full-Year Growth: FY 2024 net product revenue totaled $385.7M, up 88% YoY .
- Strong Commercial Momentum: Auvelity achieved 158,000 prescriptions in Q4 with nearly 165,000 cumulative new patient starts .
- Accelerated Pipeline Progress: Multiple Phase 3 milestones were reached with AXS-05 (Alzheimer’s agitation) and AXS-12 (narcolepsy with cataplexy, with NDA submissions anticipated in 2H 2025 ), plus ongoing progress on AXS-14 for fibromyalgia .
- Solid Financial Position: Closed 2024 with a cash balance of $315.4M despite a Q4 net loss of $74.9M .
- Axsome Therapeutics has settled its patent litigation with Teva Pharmaceuticals regarding the AUVELITY product, as disclosed in the 8-K filing.
- Under the settlement, Axsome will grant Teva a license to sell a generic version of AUVELITY starting March 31, 2039 if pediatric exclusivity is granted, or September 30, 2038 if not, subject to FDA approval and customary conditions.
- FDA approved SYMBRAVO (a combination of 20 mg meloxicam/10 mg rizatriptan) for the acute treatment of migraine with or without aura in adults, with the approval announced one day ahead of the PDUFA goal date .
- Approval was based on robust Phase III trials (INTERCEPT and MOMENTUM) demonstrating rapid pain freedom at 2 hours and sustained relief through 24–48 hours, with a high percentage of patients not requiring rescue medication .
- The treatment leverages rapid absorption technology and a multi-mechanistic approach, addressing critical unmet needs in migraine therapeutics, and is approved exclusively for acute treatment (not for prevention) .
- A targeted commercial launch is planned in approximately four months, focusing on headache centers and specialists .
- The commercial opportunity is significant, with projected peak sales of $500 million to $1 billion .
- Axsome Therapeutics reported preliminary Q4 2024 total product revenue of $118.3 million and full-year revenue of $385.2 million.
- Auvelity net sales were approximately $92.6 million in Q4 (full year $291.4 million), while Sunosi generated about $25.7 million in Q4 (full year $93.8 million).
- The company highlighted strong revenue growth in 2024 with plans to advance regulatory filings for AXS-05 and AXS-12 in 2025.