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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): February 20, 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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 February 20, 2024, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months and fiscal year ended December 31, 2023 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 February 20, 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:	February 20, 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 Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

 

Total 4Q and full year 2023 net product revenue of $71.5 million and $204.9 million, respectively, representing year-over-year growth of 193% and 309%

 

Auvelity 4Q and full year 2023 net product sales of $49.0 million and $130.1 million, respectively, during the first full year of launch

 

Sunosi 4Q and full year 2023 net product revenue of $22.5 million and $74.8 million, respectively, representing 17% and 67% year-over-year growth

 

NDA submission for AXS-14 in fibromyalgia and NDA resubmission for AXS-07 in migraine, both anticipated in 1H 2024

 

Topline results of the SYMPHONY Phase 3 trial in narcolepsy anticipated in 1Q 2024

 

Topline results of the ADVANCE-2 Phase 3 trial in Alzheimer’s disease agitation and the FOCUS Phase 3 trial in ADHD expected in 2H 2024

 

Initiation of Phase 3 trials of solriamfetol in major depressive disorder, binge eating disorder, and shift work disorder expected 1Q 2024

 

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

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Financial Guidance

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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.

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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.

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).

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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

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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

(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

 

 

 

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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: 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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