AXSM Axsome Therapeutics Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 06, 2024

 

 

Axsome Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-37635	45-4241907
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
One World Trade Center, 22nd Floor
New York, New York				10007
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (212) 332-3241

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, Par Value $0.0001 Per Share		AXSM		Nasdaq Global Market

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. ☐

 

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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

 

Exhibit No.		Description
99.1		Press Release dated May 6, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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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.

			Axsome Therapeutics, Inc.
Date:	May 6, 2024	By:	/s/ Herriot Tabuteau, M.D.
		Name: Title:	Herriot Tabuteau, M.D. President and Chief Executive Officer

 

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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

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Financial Guidance

Commercial Highlights

Auvelity

 

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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).

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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)

 

		March 31,				December 31,
		2024				2023
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	331,441			$	386,193
Accounts receivables, net			101,434				94,820
Inventories, net			15,583				15,135
Prepaid and other current assets			12,032				8,115
Total current assets			460,490				504,263
Equipment, net			812				846
Right-of-use asset - operating lease			6,411				6,772
Goodwill			12,042				12,042
Intangible asset, net			51,697				53,286
Non-current inventory and other assets			14,276				11,027
Total assets		$	545,728			$	588,236
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	53,791			$	40,679
Accrued expenses and other current liabilities			82,716				90,501
Operating lease liability, current portion			1,153				1,267
Contingent consideration, current			6,388				6,407
Total current liabilities			144,048				138,854
Contingent consideration, non-current			70,000				73,300
Loan payable, long-term			178,689				178,070
Operating lease liability, long-term			7,258				7,035
Finance lease liability, long-term			1,697				—
Total liabilities			401,692				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, 47,464,575 and 47,351,363 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively)			5				5
Additional paid-in capital			1,047,959				1,026,543
Accumulated deficit			(903,928	)			(835,571	)
Total stockholders’ equity			144,036				190,977
Total liabilities and stockholders’ equity		$	545,728			$	588,236

 

 

 

 

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Axsome Therapeutics, Inc.

Consolidated Statements of Operations (Unaudited)

(In thousands, except share and per share amounts)

 

		Three months ended March 31,
		2024				2023
Revenues:
Product sales, net		$	74,096			$	28,569
License revenue			—				65,735
Royalty revenue			903				272
Total revenues			74,999				94,576
Operating expenses:
Cost of revenue (excluding amortization and depreciation)			6,297				7,556
Research and development			36,830				17,793
Selling, general and administrative			98,970				74,191
Gain in fair value of contingent consideration			(1,412	)			(162	)
Intangible asset amortization			1,589				1,572
Total operating expenses			142,274				100,950
Loss from operations			(67,275	)			(6,374	)
Interest expense, net			(1,082	)			(2,264	)
Loss before income taxes			(68,357	)			(8,638	)
Income tax expense			—				(2,580	)
Net loss		$	(68,357	)		$	(11,218	)
Net loss per common share, basic and diluted		$	(1.44	)		$	(0.26	)
Weighted average common shares outstanding, basic and diluted			47,393,563				43,523,631

 

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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v3.24.1.u1

Document And Entity Information	May 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 06, 2024
Entity Registrant Name	Axsome Therapeutics, Inc.
Entity Central Index Key	0001579428
Entity Emerging Growth Company	false
Entity File Number	001-37635
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	45-4241907
Entity Address, Address Line One	One World Trade Center, 22nd Floor
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10007
City Area Code	(212)
Local Phone Number	332-3241
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, Par Value $0.0001 Per Share
Trading Symbol	AXSM
Security Exchange Name	NASDAQ

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