NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced reported financial results for the fourth quarter and full year of 2023.
“2023 was a transformational year for Axsome, based on successful commercial execution as well as substantial pipeline advancement and expansion. During our first full year as a commercial company, Auvelity and Sunosi were prescribed for more than 100,000 patients combined. We expanded our Auvelity neuropsychiatry sales force and progressed our NDAs for AXS-07 in migraine and AXS-14 in fibromyalgia. We advanced our Phase 3 trials of AXS-12 in narcolepsy and AXS-05 in Alzheimer’s disease agitation, initiated a Phase 3 pivotal trial program for solriamfetol in ADHD, and announced three additional new indications for solriamfetol,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We expect to continue the momentum in 2024 as we drive further growth for our two currently marketed products, and potentially submit two NDAs for migraine and fibromyalgia, read out three Phase 3 trials in narcolepsy, Alzheimer’s disease agitation, and ADHD, and, in the near term, initiate an equal number of new pivotal trials in depression, binge eating disorder, and shift work disorder. Enrollment in the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy is now complete and we are on track to report topline results this quarter.”
Fourth Quarter 2023 and Full Year Financial Highlights
Financial Guidance
Commercial Highlights
Auvelity
Sunosi
Development Pipeline
Axsome is advancing an industry-leading neuroscience portfolio encompassing five innovative, late-stage, patent-protected product candidates for 10 serious psychiatric and neurologic conditions, which affect more than 150 million people in the U.S. alone. 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 and sigma-1 agonist being developed for Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for AD agitation.
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor 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 and TAAR1 agonist in development 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).
Anticipated Milestones
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss fourth quarter and full year 2023 financial results as well as to provide a corporate update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We 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 our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our 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 our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our 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 our 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; unforeseen circumstances or other disruptions to normal business operations arising from or related to 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 (Unaudited, in thousands, except for share and per share amounts) | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 386,193 | $ | 200,842 | ||||
| Accounts receivables, net | 94,820 | 37,699 | ||||||
| Inventories, net | 15,135 | 4,320 | ||||||
| Prepaid and other current assets | 8,115 | 2,781 | ||||||
| Total current assets | 504,263 | 245,642 | ||||||
| Equipment, net | 846 | 722 | ||||||
| Right-of-use asset - operating lease | 6,772 | 420 | ||||||
| Goodwill | 12,042 | 10,310 | ||||||
| Intangible asset, net | 53,286 | 59,661 | ||||||
| Non-current inventory and other assets | 11,027 | 14,721 | ||||||
| Total assets | $ | 588,236 | $ | 331,476 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 40,679 | $ | 38,605 | ||||
| Accrued expenses and other current liabilities | 90,501 | 51,631 | ||||||
| Operating lease liability, current portion | 1,267 | 425 | ||||||
| Contingent consideration, current | 6,407 | 5,900 | ||||||
| Total current liabilities | 138,854 | 96,561 | ||||||
| Contingent consideration, non-current | 73,300 | 31,100 | ||||||
| Loan payable, long-term | 178,070 | 94,259 | ||||||
| Operating lease liability, long-term | 7,035 | — | ||||||
| Total liabilities | 397,259 | 221,920 | ||||||
| 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, 47,351,363 and 43,498,617 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively) | 5 | 4 | ||||||
| Additional paid-in capital | 1,026,543 | 705,885 | ||||||
| Accumulated deficit | (835,571 | ) | (596,333 | ) | ||||
| Total stockholders’ equity | 190,977 | 109,556 | ||||||
| Total liabilities and stockholders’ equity | $ | 588,236 | $ | 331,476 | ||||
Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 70,747 | $ | 24,372 | $ | 202,460 | $ | 50,037 | ||||||||
| License revenue | — | — | 65,735 | — | ||||||||||||
| Royalty revenue | 784 | — | 2,405 | — | ||||||||||||
| Total revenues | 71,531 | 24,372 | 270,600 | 50,037 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue (excluding amortization and depreciation) | 7,377 | 2,291 | 26,065 | 5,198 | ||||||||||||
| Research and development | 30,803 | 14,693 | 97,944 | 57,947 | ||||||||||||
| Selling, general and administrative | 86,810 | 61,498 | 323,123 | 159,254 | ||||||||||||
| Loss in fair value of contingent consideration | 43,207 | 4,200 | 48,918 | 3,298 | ||||||||||||
| Intangible asset amortization | 1,607 | 1,607 | 6,375 | 4,139 | ||||||||||||
| Total operating expenses | 169,804 | 84,289 | 502,425 | 229,836 | ||||||||||||
| Loss from operations | (98,273 | ) | (59,917 | ) | (231,825 | ) | (179,799 | ) | ||||||||
| Interest expense, net | (703 | ) | (1,323 | ) | (6,453 | ) | (7,335 | ) | ||||||||
| Loss before income taxes | (98,976 | ) | (61,240 | ) | (238,278 | ) | (187,134 | ) | ||||||||
| Income tax benefit (expense) | 325 | — | (960 | ) | — | |||||||||||
| Net loss | $ | (98,651 | ) | $ | (61,240 | ) | $ | (239,238 | ) | $ | (187,134 | ) | ||||
| Net loss per common share, basic and diluted | $ | (2.08 | ) | $ | (1.41 | ) | $ | (5.27 | ) | $ | (4.60 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 47,329,782 | 43,447,309 | 45,425,212 | 40,655,941 | ||||||||||||
Axsome Contacts:
Investors:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 212-332-3243
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
www.axsome.com
Media:
Darren Opland
Director, Corporate Communications
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 929-837-1065
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
www.axsome.com
| Last Trade: | US$89.18 |
| Daily Change: | 4.57 5.40 |
| Daily Volume: | 143,806 |
| Market Cap: | US$4.320B |
December 30, 2024 November 26, 2024 November 12, 2024 November 08, 2024 October 29, 2024 | |
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