NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the third quarter of 2024 and provided a general business update.
“In the third quarter, we continued our strong commercial performance and advanced our innovative, industry-leading, late-stage development pipeline towards important near-term milestones,” said Herriot Tabuteau, MD, Chief Executive Officer. “In response to continued strong demand growth, a second expansion of the Auvelity sales force is planned for the first quarter of 2025. In addition, with the January 31, 2025, PDUFA date for our AXS-07 product candidate for migraine fast approaching, commercial preparations are underway for a timely and successful launch, if approved.”
“We expect a busy end to the year with several clinical catalysts anticipated, including a planned simultaneous release of topline results from the ongoing Phase 3 ADVANCE-2 and ACCORD-2 trials of AXS-05 in Alzheimer’s disease agitation in the fourth quarter,” Dr. Tabuteau added. “Our growth as an organization positions us well to potentially deliver multiple innovative new medicines to the millions of individuals living with central nervous system disorders in the U.S. Importantly, we have the resources in hand to execute our operating plans and create substantial value for shareholders.”
Third Quarter 2024 Financial Highlights
Financial Guidance
Commercial Highlights
Auvelity
Sunosi
Development Pipeline
Axsome is advancing an industry-leading neuroscience pipeline encompassing five innovative, late-stage, patent-protected product candidates for nine serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation.
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational selective COX-2 inhibitor and 5-HT1B/1D agonist being developed for the acute treatment of migraine.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.
Solriamfetol
Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
Scientific Presentations
Corporate Update
Anticipated Milestones
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its third quarter 2024 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of the Company’s Sunosi® and Auvelity® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to the Company’s special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
| Axsome Therapeutics, Inc. Selected Consolidated Financial Data Axsome Therapeutics, Inc. Consolidated Balance Sheets (In thousands, except share and per share amounts) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 327,341 | $ | 386,193 | ||||
| Accounts receivables, net | 124,096 | 94,820 | ||||||
| Inventories, net | 14,265 | 15,135 | ||||||
| Prepaid and other current assets | 13,411 | 8,115 | ||||||
| Total current assets | 479,113 | 504,263 | ||||||
| Equipment, net | 683 | 846 | ||||||
| Right-of-use asset - operating lease | 5,730 | 6,772 | ||||||
| Goodwill | 12,042 | 12,042 | ||||||
| Intangible asset, net | 48,501 | 53,286 | ||||||
| Non-current inventory and other assets | 15,389 | 11,027 | ||||||
| Total assets | $ | 561,458 | $ | 588,236 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 64,253 | $ | 40,679 | ||||
| Accrued expenses and other current liabilities | 122,176 | 90,501 | ||||||
| Operating lease liability, current portion | 1,627 | 1,267 | ||||||
| Contingent consideration, current | 8,131 | 6,407 | ||||||
| Total current liabilities | 196,187 | 138,854 | ||||||
| Contingent consideration, non-current | 82,980 | 73,300 | ||||||
| Loan payable, long-term | 180,002 | 178,070 | ||||||
| Operating lease liability, long-term | 6,440 | 7,035 | ||||||
| Finance lease liability, long-term | 2,951 | — | ||||||
| Total liabilities | 468,560 | 397,259 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) | — | — | ||||||
| Common stock, $0.0001 par value per share (150,000,000 shares authorized, 48,436,108 and 47,351,363 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively) | 5 | 5 | ||||||
| Additional paid-in capital | 1,140,768 | 1,026,543 | ||||||
| Accumulated deficit | (1,047,875 | ) | (835,571 | ) | ||||
| Total stockholders’ equity | 92,898 | 190,977 | ||||||
| Total liabilities and stockholders’ equity | $ | 561,458 | $ | 588,236 | ||||
| Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 103,736 | $ | 57,127 | $ | 264,352 | $ | 131,713 | ||||||||
| License revenue | — | — | — | 65,735 | ||||||||||||
| Royalty revenue | 1,026 | 667 | 2,575 | 1,622 | ||||||||||||
| Total revenues | 104,762 | 57,794 | 266,927 | 199,070 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue (excluding amortization and depreciation) | 8,437 | 6,532 | 22,789 | 18,687 | ||||||||||||
| Research and development | 45,388 | 28,767 | 132,071 | 67,141 | ||||||||||||
| Selling, general and administrative | 95,564 | 83,188 | 298,088 | 236,314 | ||||||||||||
| Loss (Gain) in fair value of contingent consideration | 16,391 | (180 | ) | 17,139 | 5,711 | |||||||||||
| Intangible asset amortization | 1,606 | 1,607 | 4,785 | 4,768 | ||||||||||||
| Total operating expenses | 167,386 | 119,914 | 474,872 | 332,621 | ||||||||||||
| Loss from operations | (62,624 | ) | (62,120 | ) | (207,945 | ) | (133,551 | ) | ||||||||
| Interest expense, net | (1,978 | ) | (757 | ) | (4,359 | ) | (5,751 | ) | ||||||||
| Loss before income taxes | (64,602 | ) | (62,877 | ) | (212,304 | ) | (139,302 | ) | ||||||||
| Income tax benefit (expense) | — | 678 | — | (1,285 | ) | |||||||||||
| Net loss | $ | (64,602 | ) | $ | (62,199 | ) | $ | (212,304 | ) | $ | (140,587 | ) | ||||
| Net loss per common share, basic and diluted | $ | (1.34 | ) | $ | (1.32 | ) | $ | (4.45 | ) | $ | (3.14 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 48,140,519 | 47,117,196 | 47,703,508 | 44,783,380 | ||||||||||||
Investors:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
This email address is being protected from spambots. You need JavaScript enabled to view it.
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
This email address is being protected from spambots. You need JavaScript enabled to view it.
| Last Trade: | US$90.73 |
| Daily Change: | 0.99 1.10 |
| Daily Volume: | 811,249 |
| Market Cap: | US$4.400B |
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