Axsome Therapeutics第二季收入增46%至2.18億美元 惟虧損擴大至5130萬

10-Q
 
 
 
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2026
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________
Commission File Number 001-37635
 
AXSOME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 

 
 
 
 
 

 
 Delaware

 45-4241907

 

 
 (State or other jurisdiction of incorporation or organization)

 (I.R.S. Employer Identification No.)

 

  

 
 
 
 
 

 
 One World Trade Center
29th Floor
New York, New York

 10007

 

 
 (Address of principal executive offices)

 (Zip Code)

 

  
Registrant’s telephone number, including area code: (212) 332-3241
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
 

 
 
 
 
 
 
 

 
 Large accelerated filer

 ☒

 Accelerated Filer

 ☐

 

 
 Non-accelerated filer

 ☐

 Smaller reporting company

 ☐

 

 
  

  

 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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
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

  

 The Nasdaq Global Market

 

  
There were 52,380,818 shares of the registrant’s common stock, $0.0001 par value, outstanding as of August 3, 2026.
 

  

 
 Table of Contents

  

 AXSOME THERAPEUTICS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED June 30, 2026
 
TABLE OF CONTENTS
 

 
 
 
 
 
 
 

 
  

  

  

 Page

 

 
 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

  

 3

 

 
  

  

  

 

 
 PART I — FINANCIAL INFORMATION

  

  

 

 
  

  

  

  

 

 
 ITEM 1

 Financial Statements

  

 4

 

 
 ITEM 2

 Management’s Discussion and Analysis of Financial Condition and Results of Operations

  

 38

 

 
 ITEM 3

 Quantitative and Qualitative Disclosure About Market Risk

  

 50

 

 
 ITEM 4

 Controls and Procedures

  

 50

 

 
  

  

  

 

 
 PART II — OTHER INFORMATION

  

  

 

 
  

  

  

  

 

 
 ITEM 1

 Legal Proceedings

  

 51

 

 
 ITEM 1A

 Risk Factors

  

 51

 

 
 ITEM 5

 Other Information

  

 117

 

 
 ITEM 6

 Exhibits

  

 118

 

 
  

 Signatures

  

 119

 

  

 2

 
 Table of Contents

  

 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain matters discussed in this report, including matters discussed under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the Securities Exchange Act of 1934, as amended, or the Exchange Act, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. The words “anticipate,” “believe,” “estimate,” “may,” “expect” and similar expressions are generally intended to identify forward-looking statements. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation, those discussed under the captions “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report, as well as other factors which may be identified from time to time in our other filings with the U.S. Securities and Exchange Commission, or the SEC, or in the documents where such forward-looking statements appear. All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by these cautionary statements. Such forward-looking statements include, but are not limited to, statements about:
•our expectations for increases or decreases in expenses;

•our expectations for the clinical and preclinical development, manufacturing and regulatory approval of our product candidates, and commercialization of our pharmaceutical products or any other products that we may acquire or in-license;

•our estimates of the sufficiency of our existing capital resources combined with future anticipated cash flows to finance our operating requirements;

•our expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities;

•unforeseen circumstances or other disruptions to normal business operations arising from or related to geopolitical conflicts or pandemics;

•our future revenue projections, sales forecasts, and potential peak market data;

•our expectations for generating revenue or becoming profitable on a sustained basis;

•our expectations or ability to enter into marketing and other partnership agreements;

•our expectations or ability to enter into product acquisitions and in-licensing transactions;

•our expectations or ability to build our own commercial infrastructure to manufacture, market and sell our products;

•our expected losses;

•our ability to obtain and maintain intellectual property protection for our products;

•the acceptance of our products by doctors, patients, or payors;

•our stock price and its volatility;

•our ability to attract and retain key personnel;

•the performance of third-party manufacturers;

•our expectations for future capital requirements; and

•our ability to successfully implement our strategy.

The forward-looking statements contained in this report reflect our views and assumptions only as of the date that this report is signed. Except as required by law, we assume no responsibility for updating any forward-looking statements.
We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

 3

 
 Table of Contents

  

 PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Axsome Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 June 30,
2026

  

  

 December 31,
2025

  

 

 
  

  

 (Unaudited)

  

  

  

  

 

 
 Assets

  

  

  

  

  

  

 

 
 Current assets:

  

  

  

  

  

  

 

 
 Cash and cash equivalents

  

 $

 319,850

  

  

 $

 322,933

  

 

 
 Accounts receivable, net

  

  

 277,459

  

  

  

 224,464

  

 

 
 Inventories, net

  

  

 37,883

  

  

  

 27,938

  

 

 
 Prepaid and other current assets

  

  

 21,377

  

  

  

 13,651

  

 

 
 Total current assets

  

  

 656,569

  

  

  

 588,986

  

 

 
 Equipment, net

  

  

 874

  

  

  

 562

  

 

 
 Right-of-use asset - operating lease

  

  

 19,157

  

  

  

 20,858

  

 

 
 Goodwill

  

  

 12,042

  

  

  

 12,042

  

 

 
 Intangible asset, net

  

  

 37,358

  

  

  

 40,519

  

 

 
 Non-current inventory and other assets

  

  

 35,447

  

  

  

 26,838

  

 

 
 Total assets

  

 $

 761,447

  

  

 $

 689,805

  

 

 
 Liabilities and stockholders’ equity

  

  

  

  

  

  

 

 
 Current liabilities:

  

  

  

  

  

  

 

 
 Accounts payable

  

 $

 78,969

  

  

 $

 65,537

  

 

 
 Accrued expenses and other current liabilities

  

  

 299,632

  

  

  

 232,853

  

 

 
 Operating lease liability, current portion

  

  

 646

  

  

  

 434

  

 

 
 Contingent consideration, current

  

  

 11,199

  

  

  

 10,012

  

 

 
 Short-term borrowings

  

  

 70,000

  

  

  

 70,000

  

 

 
 Total current liabilities

  

  

 460,446

  

  

  

 378,836

  

 

 
 Contingent consideration, non-current

  

  

 69,135

  

  

  

 77,540

  

 

 
 Loan payable, long-term

  

  

 117,958

  

  

  

 117,746

  

 

 
 Operating lease liability, long-term

  

  

 21,574

  

  

  

 23,182

  

 

 
 Finance lease liability, long-term

  

  

 9,030

  

  

  

 4,206

  

 

 
 Total liabilities

  

  

 678,143

  

  

  

 601,510

  

 

 
 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, 52,299,889 and 50,882,766 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively)

  

  

 5

  

  

  

 5

  

 

 
 Additional paid-in capital

  

  

 1,505,116

  

  

  

 1,394,251

  

 

 
 Accumulated deficit

  

  

 (1,421,817

 )

  

  

 (1,305,961

 )

 

 
 Total stockholders’ equity

  

  

 83,304

  

  

  

 88,295

  

 

 
 Total liabilities and stockholders’ equity

  

 $

 761,447

  

  

 $

 689,805

  

 

  
The accompanying notes are an integral part of the consolidated financial statements.

 4

 
 Table of Contents

  

 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,

  

 

 
  

  

 2026

  

  

 2025

  

  

 2026

  

  

 2025

  

 

 
 Revenues:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Product sales, net

  

 $

 216,355

  

  

 $

 148,959

  

  

 $

 405,755

  

  

 $

 269,317

  

 

 
 Royalty revenue and milestone revenue

  

  

 2,020

  

  

  

 1,083

  

  

  

 3,823

  

  

  

 2,188

  

 

 
 Total revenues

  

  

 218,375

  

  

  

 150,042

  

  

  

 409,578

  

  

  

 271,505

  

 

 
 Operating expenses:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Cost of revenue (excluding amortization and depreciation)

  

  

 13,564

  

  

  

 13,448

  

  

  

 28,289

  

  

  

 23,237

  

 

 
 Research and development

  

  

 46,227

  

  

  

 49,541

  

  

  

 98,904

  

  

  

 94,326

  

 

 
 Selling, general and administrative

  

  

 208,137

  

  

  

 130,280

  

  

  

 393,133

  

  

  

 251,067

  

 

 
 Gain in fair value of contingent consideration

  

  

 (1,496

 )

  

  

 (8,102

 )

  

  

 (906

 )

  

  

 (6,590

 )

 

 
 Intangible asset amortization

  

  

 1,589

  

  

  

 1,589

  

  

  

 3,161

  

  

  

 3,161

  

 

 
 Total operating expenses

  

  

 268,021

  

  

  

 186,756

  

  

  

 522,581

  

  

  

 365,201

  

 

 
 Loss from operations

  

  

 (49,646

 )

  

  

 (36,714

 )

  

  

 (113,003

 )

  

  

 (93,696

 )

 

 
 Interest expense, net

  

  

 (1,540

 )

  

  

 (1,834

 )

  

  

 (2,725

 )

  

  

 (4,265

 )

 

 
 Loss on debt extinguishment

  

  

 —

  

  

  

 (10,385

 )

  

  

 —

  

  

  

 (10,385

 )

 

 
 Loss before income taxes

  

  

 (51,186

 )

  

  

 (48,933

 )

  

  

 (115,728

 )

  

  

 (108,346

 )

 

 
 Income tax benefit (expense)

  

  

 (128

 )

  

  

 960

  

  

  

 (128

 )

  

  

 960

  

 

 
 Net loss

  

 $

 (51,314

 )

  

 $

 (47,973

 )

  

 $

 (115,856

 )

  

 $

 (107,386

 )

 

 
 Net loss per common share, basic and diluted

  

 $

 (0.99

 )

  

 $

 (0.97

 )

  

 $

 (2.25

 )

  

 $

 (2.18

 )

 

 
 Weighted average common shares outstanding, basic and diluted

  

  

 51,799,708

  

  

  

 49,442,001

  

  

  

 51,500,690

  

  

  

 49,158,159

  

 

  
The accompanying notes are an integral part of the consolidated financial statements.

 5

 
 Table of Contents

  

 Axsome Therapeutics, Inc.
Consolidated Statements of Stockholders’ Equity (Unaudited)
(In thousands, except share amounts)

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Common stock

  

  

 Additional paid-in

  

  

 Accumulated

  

  

 Total
stockholders’

  

 

 
  

  

 Shares

  

  

 Amount

  

  

 capital

  

  

 deficit

  

  

 equity

  

 

 
 Balance at December 31, 2024

  

  

 48,667,587

  

  

  

 5

  

  

  

 1,179,797

  

  

  

 (1,122,787

 )

  

  

 57,015

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 23,647

  

  

  

 —

  

  

  

 23,647

  

 

 
 Issuance of common stock upon exercise of options

  

  

 331,853

  

  

  

 —

  

  

  

 17,035

  

  

  

 —

  

  

  

 17,035

  

 

 
 Issuance of common stock upon vesting of RSUs

  

  

 60,835

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Issuance of common stock upon financing

  

  

 156,484

  

  

  

 —

  

  

  

 19,257

  

  

  

 —

  

  

  

 19,257

  

 

 
 Shares tendered for withholding taxes

  

  

 —

  

  

  

 —

  

  

  

 (4,336

 )

  

  

 —

  

  

  

 (4,336

 )

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (59,413

 )

  

  

 (59,413

 )

 

 
 Balance at March 31, 2025

  

  

 49,216,759

  

  

  

 5

  

  

  

 1,235,400

  

  

  

 (1,182,200

 )

  

  

 53,205

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 24,954

  

  

  

 —

  

  

  

 24,954

  

 

 
 Issuance of common stock upon exercise of options and under employee stock purchase plan

  

  

 276,280

  

  

  

 —

  

  

  

 11,661

  

  

  

 —

  

  

  

 11,661

  

 

 
 Issuance of common stock upon vesting of RSUs

  

  

 15,776

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Issuance of common stock upon financing

  

  

 306,486

  

  

  

 —

  

  

  

 32,116

  

  

  

 —

  

  

  

 32,116

  

 

 
 Shares tendered for withholding taxes

  

  

 —

  

  

  

 —

  

  

  

 (888

 )

  

  

 —

  

  

  

 (888

 )

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (47,973

 )

  

  

 (47,973

 )

 

 
 Balance at June 30, 2025

  

  

 49,815,301

  

  

  

 5

  

  

  

 1,303,243

  

  

  

 (1,230,173

 )

  

  

 73,075

  

 

 
 Balance at December 31, 2025

  

  

 50,882,766

  

  

  

 5

  

  

  

 1,394,251

  

  

  

 (1,305,961

 )

  

  

 88,295

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 23,906

  

  

  

 —

  

  

  

 23,906

  

 

 
 Issuance of common stock upon exercise of options

  

  

 412,310

  

  

  

 —

  

  

  

 9,981

  

  

  

 —

  

  

  

 9,981

  

 

 
 Issuance of common stock upon vesting of RSUs

  

  

 89,567

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Issuance of common stock upon financing

  

  

 35,802

  

  

  

 —

  

  

  

 6,248

  

  

  

 —

  

  

  

 6,248

  

 

 
 Shares tendered for withholding taxes

  

  

 —

  

  

  

 —

  

  

  

 (9,301

 )

  

  

 —

  

  

  

 (9,301

 )

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (64,542

 )

  

  

 (64,542

 )

 

 
 Balance at March 31, 2026

  

  

 51,420,445

  

  

  

 5

  

  

  

 1,425,085

  

  

  

 (1,370,503

 )

  

  

 54,587

  

 

 
 Stock-based compensation

  

  

 —

  

  

  

 —

  

  

  

 27,625

  

  

  

 —

  

  

  

 27,625

  

 

 
 Issuance of common stock upon exercise of options and under employee stock purchase plan

  

  

 755,644

  

  

  

 —

  

  

  

 41,968

  

  

  

 —

  

  

  

 41,968

  

 

 
 Issuance of common stock upon vesting of RSUs

  

  

 28,979

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Issuance of common stock upon financing

  

  

 54,644

  

  

  

 —

  

  

  

 13,272

  

  

  

 —

  

  

  

 13,272

  

 

 
 Issuance of common stock upon exercise of warrants

  

  

 40,177

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

 

 
 Shares tendered for withholding taxes

  

  

 —

  

  

  

 —

  

  

  

 (2,834

 )

  

  

 —

  

  

  

 (2,834

 )

 

 
 Net loss

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (51,314

 )

  

  

 (51,314

 )

 

 
 Balance at June 30, 2026

  

  

 52,299,889

  

  

 $

 5

  

  

 $

 1,505,116

  

  

 $

 (1,421,817

 )

  

 $

 83,304

  

 

  
The accompanying notes are an integral part of the consolidated financial statements.

 6

 
 Table of Contents

  

 Axsome Therapeutics, Inc.
Consolidated Statements of Cash Flows (Unaudited)
(In thousands)

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Six months ended June 30,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Cash flows from operating activities

  

  

  

  

  

  

 

 
 Net loss

  

 $

 (115,856

 )

  

 $

 (107,386

 )

 

 
 Adjustments to reconcile net loss to net cash used in operating activities:

  

  

  

  

  

  

 

 
 Stock-based compensation expense

  

  

 50,586

  

  

  

 47,919

  

 

 
 Amortization of intangible asset

  

  

 3,161

  

  

  

 3,161

  

 

 
 Amortization of debt discount

  

  

 323

  

  

  

 984

  

 

 
 Loss on debt extinguishment

  

  

 —

  

  

  

 10,385

  

 

 
 Depreciation

  

  

 259

  

  

  

 269

  

 

 
 Gain in fair value of contingent consideration

  

  

 (906

 )

  

  

 (6,590

 )

 

 
 Gain from lease modification

  

  

 —

  

  

  

 (2,250

 )

 

 
 Non-cash lease expense

  

  

 1,701

  

  

  

 1,432

  

 

 
 Right-of-use asset amortization for finance lease

  

  

 1,834

  

  

  

 949

  

 

 
 Changes in operating assets and liabilities:

  

  

  

  

  

  

 

 
 Accounts receivable, net

  

  

 (52,995

 )

  

  

 (56,824

 )

 

 
 Inventories, net

  

  

 (9,000

 )

  

  

 (2,026

 )

 

 
 Prepaid expenses and other current assets

  

  

 (7,726

 )

  

  

 (4,360

 )

 

 
 Non-current inventory and other assets

  

  

 (907

 )

  

  

 (3,223

 )

 

 
 Accounts payable

  

  

 13,432

  

  

  

 19,631

  

 

 
 Accrued expenses and other current liabilities

  

  

 63,839

  

  

  

 22,322

  

 

 
 Operating lease liability

  

  

 (1,397

 )

  

  

 (191

 )

 

 
 Net cash used in operating activities

  

  

 (53,652

 )

  

  

 (75,798

 )

 

 
 Cash flows from investing activities

  

  

  

  

  

  

 

 
 Purchases of equipment

  

  

 (571

 )

  

  

 (351

 )

 

 
 Net cash used in investing activities

  

  

 (571

 )

  

  

 (351

 )

 

 
 Cash flows from financing activities

  

  

  

  

  

  

 

 
 Proceeds from draw down of debt

  

  

 140,000

  

  

  

 190,000

  

 

 
 Payment of debt issuance costs

  

  

 —

  

  

  

 (3,638

 )

 

 
 Repayment of debt

  

  

 (140,000

 )

  

  

 (191,988

 )

 

 
 Payments on principal portion of finance lease obligation

  

  

 (1,882

 )

  

  

 (919

 )

 

 
 Proceeds from issuance of common stock upon financing

  

  

 19,817

  

  

  

 52,283

  

 

 
 Cash paid for common stock issuance costs

  

  

 (297

 )

  

  

 (910

 )

 

 
 Proceeds from issuance of common stock upon exercise of options and under employee stock purchase plan

  

  

 51,949

  

  

  

 28,696

  

 

 
 Payment of contingent consideration

  

  

 (6,312

 )

  

  

 (4,488

 )

 

 
 Payments of tax withholdings on stock awards

  

  

 (12,135

 )

  

  

 (5,224

 )

 

 
 Net cash provided by financing activities

  

  

 51,140

  

  

  

 63,812

  

 

 
 Net decrease in cash

  

  

 (3,083

 )

  

  

 (12,337

 )

 

 
 Cash at beginning of period

  

  

 322,933

  

  

  

 315,353

  

 

 
 Cash at end of period

  

 $

 319,850

  

  

 $

 303,016

  

 

 
 Supplemental disclosures of cash flow information:

  

  

  

  

  

  

 

 
 Interest paid

  

 $

 5,969

  

  

 $

 8,359

  

 

 
 Operating lease right-of-use asset obtained in exchange for operating lease liability

  

  

 —

  

  

  

 23,869

  

 

 
 Finance lease right-of-use asset obtained in exchange for finance lease liability

  

  

 10,427

  

  

  

 2,360

  

 

 
 Decrease in operating lease right-of-use asset due to lease modification

  

  

 —

  

  

  

 5,349

  

 

 
 Decrease in operating lease liability due to lease modification

  

  

 —

  

  

  

 7,599

  

 

  
The accompanying notes are an integral part of the consolidated financial statements.

 7

 
 Table of Contents

  

 Axsome Therapeutics, Inc.
Notes to Consolidated Financial Statements (Unaudited)
(In thousands, except share and per share amounts)
Note 1. Nature of Business and Basis of Presentation
Axsome Therapeutics, Inc. (“Axsome” or the “Company”), based in New York, New York, is a biopharmaceutical company dedicated to the development and commercialization of innovative medicines to improve the brain health of individuals living with central nervous system (“CNS”) conditions. Axsome has a broad and diverse commercial portfolio of four U.S. Food and Drug Administration (“FDA”) approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease (AADDAD), excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, and migraine. Additionally, Axsome is advancing a deep pipeline of numerous novel product candidates in early- to late-stage development targeting a range of serious, underserved conditions across psychiatry and neurology that collectively impact over 150 million people in the United States.
SUNOSI® is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT1A agonist approved in the United States, the European Union, and Canada for the treatment of excessive daytime sleepiness in adult patients with obstructive sleep apnea or narcolepsy. SUNOSI was approved by the FDA in March 2019, by the European Commission in January 2020, and by Health Canada in May 2021. The Company acquired the U.S. rights to SUNOSI in May 2022 and, in November 2022, acquired worldwide ex-U.S. rights, excluding certain Asian markets. In February 2023, the Company announced a licensing transaction with Atnahs Pharma UK Limited (“Pharmanovia”) to market SUNOSI in Europe and certain countries in the Middle East / North Africa.
AUVELITY® (dextromethorphan-bupropion), also referred to as “AXS-05”, was developed by the Company and approved by the FDA in August 2022 as the first and only oral, N-methyl-D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder in adults (MDD). The Company initiated the commercial availability of AUVELITY in October 2022. In April 2026, the FDA approved AUVELITY for the treatment of AADDAD. The Company initiated the commercial launch of AUVELITY for the treatment of AADDAD in June 2026.
SYMBRAVO® (MoSEICTM meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist that was developed by the Company and approved by the FDA in January 2025 for the acute treatment of migraine with or without aura in adults. The Company initiated the commercial availability of SYMBRAVO in June 2025.
In November 2025, the Company acquired global rights to AXS-17, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM). The Company plans to evaluate AXS-17 as a potential treatment for epilepsy. In December 2025, the Company acquired global rights to deuterium-stabilized S-bupropion. In the first quarter of 2026, the Company acquired AXS-20, a selective PDE10A inhibitor. The Company plans to initially develop AXS-20 in schizophrenia and Tourette syndrome.
The Company refers herein to AUVELITY, SUNOSI, SYMBRAVO (also referred to as “AXS-07”), AXS-12, AXS-14, AXS-17, AXS-20 and its programs to develop additional indications for AXS-05 and solriamfetol as the Company’s products.
The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 23, 2026.

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 In the opinion of management, the unaudited interim consolidated financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods. The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the operating results for the full fiscal year or any future period.
Liquidity and Capital Resources
The Company has incurred operating losses since its inception and expects to continue to incur operating losses and may never become profitable. As of June 30, 2026, the Company had an accumulated deficit of $1,421.8 million.
The Company’s primary sources of cash have been proceeds from the sales of AUVELITY, SUNOSI, and SYMBRAVO, the issuance and sale of its common stock in public offerings, and the issuance of debt. The Company’s ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership with third parties. The Company may continue to incur substantial operating losses even as it continues to generate revenues from its products.
The Company believes its existing cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing. During that time, the Company expects that its expenses will increase primarily due to the commercialization of AUVELITY, SUNOSI, and SYMBRAVO while continuing to further develop the Company’s pipeline assets. The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
The Company’s common stock is listed on The Nasdaq Global Market and trades under the symbol “AXSM.”

Note 2. Summary of Significant Accounting Policies
Significant Risks and Uncertainties
The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise additional capital. If the Company’s commercialization of its products is not financially successful, it will be unable to generate sufficient recurring product revenue to achieve and maintain profitability.
The Company currently has three commercial products, AUVELITY, SUNOSI, and SYMBRAVO. There can be no assurance that the Company’s research and development efforts will result in additional successfully commercialized products. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property.

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 Use of Estimates
Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significa