NEW YORK, Aug. 05, 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 financial results for the second quarter of 2024.
“We delivered another robust quarter driven by focused commercial execution and continued pipeline advancement,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We continue to see strong demand for Auvelity and increased commercial payer coverage by more than 22 million lives as of August 1st. The NDA for AXS-07 in migraine has been resubmitted, and we are tracking to submit the NDA for AXS-14 in fibromyalgia in the third quarter. Trials in four new indications for solriamfetol are now underway, and we remain on track to deliver topline results from the FOCUS Phase 3 trial in ADHD in the second half of this year. For our AXS-05 program in Alzheimer’s disease agitation, the ADVANCE-2 Phase 3 trial continues to progress, and the ACCORD-2 Phase 3 trial has reached target enrollment, positioning us to potentially report topline results for both of these pivotal trials in the second half of the year.”
Second 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 9 serious psychiatric and neurologic conditions, which affect more than 140 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 the treatment of 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 being developed for the acute treatment of migraine.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective 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 and TAAR1 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).
Business Update
Anticipated Milestones
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss second quarter 2024 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the Investors page 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”. 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) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 315,657 | $ | 386,193 | ||||
| Accounts receivables, net | 120,342 | 94,820 | ||||||
| Inventories, net | 15,220 | 15,135 | ||||||
| Prepaid and other current assets | 11,808 | 8,115 | ||||||
| Total current assets | 463,027 | 504,263 | ||||||
| Equipment, net | 724 | 846 | ||||||
| Right-of-use asset - operating lease | 6,071 | 6,772 | ||||||
| Goodwill | 12,042 | 12,042 | ||||||
| Intangible asset, net | 50,107 | 53,286 | ||||||
| Non-current inventory and other assets | 16,255 | 11,027 | ||||||
| Total assets | $ | 548,226 | $ | 588,236 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 61,340 | $ | 40,679 | ||||
| Accrued expenses and other current liabilities | 116,771 | 90,501 | ||||||
| Operating lease liability, current portion | 1,419 | 1,267 | ||||||
| Contingent consideration, current | 7,040 | 6,407 | ||||||
| Total current liabilities | 186,570 | 138,854 | ||||||
| Contingent consideration, non-current | 69,620 | 73,300 | ||||||
| Loan payable, long-term | 179,330 | 178,070 | ||||||
| Operating lease liability, long-term | 6,829 | 7,035 | ||||||
| Finance lease liability, long-term | 3,025 | — | ||||||
| Total liabilities | 445,374 | 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, 47,801,578 and 47,351,363 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively) | 5 | 5 | ||||||
| Additional paid-in capital | 1,086,120 | 1,026,543 | ||||||
| Accumulated deficit | (983,273 | ) | (835,571 | ) | ||||
| Total stockholders’ equity | 102,852 | 190,977 | ||||||
| Total liabilities and stockholders’ equity | $ | 548,226 | $ | 588,236 | ||||
| Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) | ||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 86,520 | $ | 46,017 | $ | 160,616 | $ | 74,586 | ||||||||
| License revenue | — | — | — | 65,735 | ||||||||||||
| Royalty revenue | 646 | 683 | 1,549 | 955 | ||||||||||||
| Total revenues | 87,166 | 46,700 | 162,165 | 141,276 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue (excluding amortization and depreciation) | 8,055 | 4,599 | 14,352 | 12,155 | ||||||||||||
| Research and development | 49,853 | 20,581 | 86,683 | 38,374 | ||||||||||||
| Selling, general and administrative | 103,554 | 78,935 | 202,524 | 153,126 | ||||||||||||
| Loss in fair value of contingent consideration | 2,160 | 6,053 | 748 | 5,891 | ||||||||||||
| Intangible asset amortization | 1,590 | 1,589 | 3,179 | 3,161 | ||||||||||||
| Total operating expenses | 165,212 | 111,757 | 307,486 | 212,707 | ||||||||||||
| Loss from operations | (78,046 | ) | (65,057 | ) | (145,321 | ) | (71,431 | ) | ||||||||
| Interest expense, net | (1,299 | ) | (2,730 | ) | (2,381 | ) | (4,994 | ) | ||||||||
| Loss before income taxes | (79,345 | ) | (67,787 | ) | (147,702 | ) | (76,425 | ) | ||||||||
| Income tax benefit (expense) | — | 617 | — | (1,963 | ) | |||||||||||
| Net loss | $ | (79,345 | ) | $ | (67,170 | ) | $ | (147,702 | ) | $ | (78,388 | ) | ||||
| Net loss per common share, basic and diluted | $ | (1.67 | ) | $ | (1.54 | ) | $ | (3.11 | ) | $ | (1.80 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 47,573,229 | 43,669,820 | 47,482,602 | 43,597,131 | ||||||||||||
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$89.33 |
| Daily Change: | 4.72 5.58 |
| Daily Volume: | 114,730 |
| Market Cap: | US$4.330B |
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