UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 6, 2024, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2024 and provided an update on the Company’s operations. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information included in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto), shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Axsome Therapeutics, Inc. |
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Date: |
May 6, 2024 |
By: |
/s/ Herriot Tabuteau, M.D. |
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Name: Title: |
Herriot Tabuteau, M.D. |
Exhibit 99.1
Axsome Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
Total 1Q 2024 net product revenue of $75.0 million, representing 160% year-over-year growth
Auvelity® 1Q 2024 net product sales of $53.4 million, representing 240% year-over-year growth
Sunosi® 1Q 2024 net product revenue of $21.6 million representing 64% year-over-year growth
Contract executed with second large group purchasing organization (GPO) for potential coverage of Auvelity
Positive pivotal Phase 3 trial results of AXS-12 in narcolepsy announced
Topline results of ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation and FOCUS Phase 3 trial of solriamfetol in ADHD both anticipated 2H 2024
ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's disease agitation initiated; enrollment completion anticipated mid-year 2024
PARADIGM and ENGAGE Phase 3 trials of solriamfetol in major depressive disorder and binge eating disorder, respectively, initiated
NDA resubmission for AXS-07 in migraine and NDA submission for AXS-14 in fibromyalgia both targeted for 2Q 2024
NEW YORK, May 6, 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 first quarter of 2024.
“The first quarter was marked by strong financial performance for our on-market products which are delivering important and differentiated treatment options for patients living with depression, narcolepsy and obstructive sleep apnea,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We also significantly advanced our innovative neuroscience pipeline in the quarter. We announced positive Phase 3 results for AXS-12 in narcolepsy, a major step toward making this new medicine available to patients living with this debilitating condition, and we launched two pivotal trials of solriamfetol in major depressive disorder and binge eating disorder. In the coming months we look forward to resubmitting our NDA for AXS-07 in migraine, and to submitting our NDA for AXS-14 in fibromyalgia. Our Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation remains on track for completion in the second half of 2024. Further, we added to the robustness of this clinical development program with the initiation of the ACCORD-2 study of AXS-05 in Alzheimer’s disease agitation, a Phase 3 randomized withdrawal trial, for which we expect to complete enrollment mid-year 2024.”
First Quarter 2024 Financial Highlights
1
Financial Guidance
Commercial Highlights
Auvelity
2
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.
Axsome recently initiated the ACCORD-2 study, a Phase 3, double-blind, placebo-controlled, randomized withdrawal trial to evaluate the efficacy and safety of AXS-05 in the treatment of AD agitation. In this study, patients from the Company’s long-term open label safety extension trial are treated with AXS-05 and monitored for treatment response based on the Cohen-Mansfield Agitation Inventory (CMAI). Approximately 140 patients who experience a treatment response are planned to be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs. The primary endpoint will be the time from randomization to relapse. The Company anticipates completion of enrollment in this study around mid-year.
ACCORD-2 adds a fourth controlled efficacy trial to the robust development program for AXS-05 in AD agitation, which now includes two parallel group trials (ADVANCE-1 and ADVANCE-2) and two randomized withdrawal trials (ACCORD-1 and ACCORD-2).
3
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine.
Axsome is conducting the EMERGE study, a multicenter, Phase 3, single-group trial evaluating the efficacy and safety of AXS-07 in the acute treatment of migraine headache in adults with a prior inadequate response to an oral CGRP inhibitor. The Company anticipates topline results from the EMERGE study in the second half of 2024.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy.
A Phase 3 open label safety extension trial of AXS-12 is currently ongoing with completion anticipated in the fourth quarter of 2024.
In March 2024, the Company also announced topline results from the CRESCENDO (Characterizing Patient Perspectives on Unmet Needs in Narcolepsy) survey of 203 narcolepsy patients with cataplexy (narcolepsy type 1 or NT1) who are currently receiving treatment. The results demonstrated high rates of persistent symptoms with 77%, 64%, and 74% continuing to experience cataplexy, EDS, and cognitive impairment, respectively, despite being on current treatments. CRESCENDO was conducted by a third-party research firm that worked with Narcolepsy Network to ensure patient privacy. Narcolepsy Network is a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia and related sleep disorders.
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.
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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
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Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss first quarter 2024 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.
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Axsome Therapeutics, Inc.
Selected Consolidated Financial Data
Axsome Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
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March 31, |
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December 31, |
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2024 |
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2023 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
331,441 |
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$ |
386,193 |
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Accounts receivables, net |
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101,434 |
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94,820 |
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Inventories, net |
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15,583 |
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15,135 |
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Prepaid and other current assets |
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12,032 |
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8,115 |
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Total current assets |
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460,490 |
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504,263 |
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Equipment, net |
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812 |
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846 |
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Right-of-use asset - operating lease |
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6,411 |
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6,772 |
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Goodwill |
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12,042 |
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12,042 |
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Intangible asset, net |
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51,697 |
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53,286 |
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Non-current inventory and other assets |
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14,276 |
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11,027 |
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Total assets |
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$ |
545,728 |
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$ |
588,236 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
53,791 |
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$ |
40,679 |
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Accrued expenses and other current liabilities |
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82,716 |
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90,501 |
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Operating lease liability, current portion |
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1,153 |
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1,267 |
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Contingent consideration, current |
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6,388 |
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6,407 |
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Total current liabilities |
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144,048 |
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138,854 |
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Contingent consideration, non-current |
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70,000 |
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73,300 |
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Loan payable, long-term |
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178,689 |
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178,070 |
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Operating lease liability, long-term |
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7,258 |
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7,035 |
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Finance lease liability, long-term |
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1,697 |
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— |
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Total liabilities |
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401,692 |
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397,259 |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) |
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— |
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— |
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Common stock, $0.0001 par value per share (150,000,000 shares authorized, 47,464,575 and 47,351,363 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively) |
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5 |
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5 |
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Additional paid-in capital |
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1,047,959 |
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1,026,543 |
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Accumulated deficit |
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(903,928 |
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(835,571 |
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Total stockholders’ equity |
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144,036 |
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190,977 |
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Total liabilities and stockholders’ equity |
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$ |
545,728 |
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$ |
588,236 |
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7
Axsome Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(In thousands, except share and per share amounts)
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Three months ended March 31, |
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2024 |
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2023 |
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Revenues: |
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Product sales, net |
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$ |
74,096 |
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$ |
28,569 |
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License revenue |
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— |
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65,735 |
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Royalty revenue |
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903 |
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272 |
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Total revenues |
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74,999 |
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94,576 |
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Operating expenses: |
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Cost of revenue (excluding amortization and depreciation) |
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6,297 |
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7,556 |
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Research and development |
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36,830 |
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17,793 |
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Selling, general and administrative |
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98,970 |
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74,191 |
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Gain in fair value of contingent consideration |
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(1,412 |
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(162 |
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Intangible asset amortization |
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1,589 |
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1,572 |
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Total operating expenses |
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142,274 |
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100,950 |
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Loss from operations |
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(67,275 |
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(6,374 |
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Interest expense, net |
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(1,082 |
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(2,264 |
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Loss before income taxes |
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(68,357 |
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(8,638 |
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Income tax expense |
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— |
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(2,580 |
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Net loss |
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$ |
(68,357 |
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$ |
(11,218 |
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Net loss per common share, basic and diluted |
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$ |
(1.44 |
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$ |
(0.26 |
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Weighted average common shares outstanding, basic and diluted |
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47,393,563 |
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43,523,631 |
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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: mjacobson@axsome.com
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: dopland@axsome.com
www.axsome.com
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