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 February 27, 2023, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months and fiscal year ended December 31, 2022 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: |
February 27, 2023 |
By: |
/s/ Herriot Tabuteau, M.D. |
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Name: Title: |
Herriot Tabuteau, M.D. |
Exhibit 99.1
Axsome Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Total fourth quarter net product sales of $24.4 million
Auvelity® launched October 19th, with fourth quarter net product sales of $5.2 million
Sunosi® fourth quarter net product sales of $19.2 million
Sunosi® license agreement for EU announced – $66 million upfront, potential milestones up to $101 million
Pro forma fourth quarter net cash in excess of $300 million
Company to host conference call today at 8:00 AM Eastern
NEW YORK, February 27, 2023 (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 reported financial results for the fourth quarter and full year ended December 31, 2022.
“The past year was a landmark for Axsome, which saw us bring our first fully in-house end-to-end developed drug to market, potentially transforming the treatment landscape for depression and providing the potential to improve the lives of millions of patients and their loved ones,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “With two differentiated products in Auvelity and Sunosi now commercialized, encouraging early launch metrics for Auvelity, a broad and advancing late-stage CNS pipeline, and a strong financial position, Axsome is well positioned to continue to deliver significant value to patients and shareholders. We are looking forward to another milestone filled year which has already kicked off with an important licensing agreement for Sunosi in Europe that serves to expand patient access to this important treatment while providing significant potential future value to Axsome. Over the next 12 to 18 months, we look to continuing to execute on the commercialization of Auvelity and Sunosi, initiating or reading out at least four registration trials in indications of high unmet need, and potentially filing four new NDAs.”
Fourth Quarter 2022 Financial Highlights
1
Financial Guidance
Commercial Highlights
Auvelity
Sunosi
2
Development Pipeline
Axsome is advancing a portfolio of differentiated, patent-protected, CNS product candidates with five in active clinical development. 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 with multimodal activity 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.
The Company is conducting the ADVANCE-2 study, a Phase 3, placebo-controlled, parallel group trial to assess the efficacy and safety of AXS-05 for the treatment of AD agitation. Patients completing ADVANCE-2 may enter a long-term open label safety extension trial. Based on current enrollment trends, the Company now anticipates completion of ADVANCE-2 in the first half of 2024, versus prior guidance of mid-2025.
Axsome recently received feedback from the FDA on the clinical development program of AXS-05 in AD agitation. The FDA feedback indicated that an NDA for AXS-05 in this indication should include placebo-controlled safety information from the ongoing ADVANCE-2 trial, as well as long-term safety data in the target patient population consisting of at least 300 patients treated for six months and 100 patients treated for one year. Based on this guidance, the Company intends to submit an NDA for AXS-05 after completion of the ongoing ADVANCE-2 and open-label safety extension trials.
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine.
3
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, investigational highly selective 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 dual-acting dopamine and norepinephrine reuptake inhibitor in development for the treatment of attention deficit hyperactivity disorder (ADHD).
Anticipated Milestones
4
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss fourth quarter 2022 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 soriamfetol 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 expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, 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; 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, 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 COVID-19; 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
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December 31, |
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December 31, |
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2022 |
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2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
200,841,955 |
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$ |
86,472,854 |
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Accounts receivables, net |
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37,698,868 |
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— |
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Inventories, net |
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4,319,921 |
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— |
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Prepaid and other current assets |
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2,780,665 |
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45,286 |
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Total current assets |
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245,641,409 |
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86,518,140 |
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Equipment, net |
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722,515 |
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283,846 |
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Right-of-use asset - operating lease |
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420,298 |
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660,162 |
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Goodwill |
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10,310,000 |
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— |
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Intangible asset, net |
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59,660,772 |
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— |
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Non-current inventory and other assets |
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14,721,101 |
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322,910 |
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Total assets |
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$ |
331,476,095 |
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$ |
87,785,058 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
38,605,312 |
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$ |
13,149,329 |
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Accrued expenses and other current liabilities |
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51,630,813 |
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9,295,180 |
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Operating lease liability, current portion |
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424,673 |
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620,675 |
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Contingent consideration, current |
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5,900,000 |
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— |
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Total current liabilities |
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96,560,798 |
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23,065,184 |
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Contingent consideration, non-current |
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31,100,000 |
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— |
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Loan payable, long-term |
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94,258,888 |
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49,089,522 |
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Total liabilities |
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221,919,686 |
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72,154,706 |
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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 at December 31, 2022 and December 31, 2021, respectively) |
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— |
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— |
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Common stock, $0.0001 par value per share (150,000,000 shares authorized, 43,498,617 and 37,816,794 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively) |
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4,350 |
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3,782 |
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Additional paid-in capital |
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705,884,795 |
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424,825,655 |
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Accumulated deficit |
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(596,332,736 |
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(409,199,085 |
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Total stockholders’ equity |
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109,556,409 |
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15,630,352 |
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Total liabilities and stockholders’ equity |
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$ |
331,476,095 |
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$ |
87,785,058 |
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6
Axsome Therapeutics, Inc.
Consolidated Statements of Operations
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Three Months Ended |
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Twelve Months Ended |
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December 31, |
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December 31, |
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2022 |
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2021 |
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2022 |
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2022 |
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Revenues: |
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Product sales, net |
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$ |
24,371,528 |
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$ |
— |
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$ |
50,037,106 |
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$ |
— |
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Operating expenses: |
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Cost of product sales |
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2,290,928 |
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— |
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5,197,595 |
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— |
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Research and development |
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14,693,083 |
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13,781,453 |
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57,947,447 |
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58,060,725 |
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Selling, general and administrative |
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61,497,347 |
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18,826,588 |
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159,253,661 |
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66,646,205 |
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Gain in fair value of contingent consideration |
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4,200,350 |
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— |
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3,298,230 |
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— |
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Intangible asset amortization |
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1,606,789 |
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— |
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4,139,228 |
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— |
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Total operating expenses |
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84,288,497 |
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32,608,041 |
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229,836,161 |
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124,706,930 |
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Loss from operations |
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(59,916,969 |
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(32,608,041 |
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(179,799,055 |
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(124,706,930 |
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Interest (expense), net |
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(1,322,643 |
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(1,368,095 |
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(7,334,596 |
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(5,696,062 |
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Net loss |
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$ |
(61,239,612 |
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$ |
(33,976,136 |
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$ |
(187,133,651 |
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$ |
(130,402,992 |
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Net loss per common share, basic and diluted |
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$ |
(1.41 |
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$ |
(0.90 |
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$ |
(4.60 |
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$ |
(3.47 |
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Weighted average common shares outstanding, basic and diluted |
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43,447,309 |
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37,764,545 |
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40,655,941 |
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37,618,599 |
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Axsome Contacts:
Investors:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
22 Cortlandt Street, 16th 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.
22 Cortlandt Street, 16th Floor
New York, NY 10007
Tel: 929-837-1065
Email: dopland@axsome.com
www.axsome.com
7