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
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(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:
|
|
Trading |
|
|
|
|
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 November 7, 2022, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended September 30, 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
|
|
|
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
|
104 |
|
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.
|
|
|
Axsome Therapeutics, Inc. |
|
|
|
|
Date: |
November 7, 2022 |
By: |
/s/ Herriot Tabuteau, M.D. |
|
|
Name: Title: |
Herriot Tabuteau, M.D. |
Exhibit 99.1
Axsome Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update
Sunosi® third quarter U.S. net sales of $16.8 million
Auvelity™ launched and available in U.S. pharmacies
SHARP study results announced demonstrating statistically significant improvement in cognitive function with Sunosi versus placebo
ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation initiated
Successful Type A meeting completed for AXS-07 for the acute treatment of migraine
Company to host conference call today at 8:00 AM Eastern
NEW YORK, November 7, 2022 (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 third quarter ended September 30, 2022.
“Axsome’s transformation into a commercial stage, fully integrated, research and development driven, CNS focused biopharmaceutical company has accelerated with the successful commercialization of Sunosi, and now the launch of Auvelity for the treatment of major depressive disorder in adults,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “While it is still extremely early days in the Auvelity launch, we are very encouraged by the interest and reception from the prescriber community thus far. Our first-in-class DCC, or digital centric commercialization, platform is already demonstrating the effectiveness and efficiency of a contemporary, integrated, omni-channel approach to meaningful customer engagements. In parallel with our commercial efforts, our industry leading neuroscience development pipeline is progressing, setting the stage for continued potentially significant value creation over the near, intermediate and long term. This late-stage portfolio comprises five differentiated, product candidates, including AXS-05 for Alzheimer’s disease agitation and smoking cessation, solriamfetol for ADHD, AXS-12 for narcolepsy, and AXS-14 for fibromyalgia. We anticipate this portfolio to generate multiple clinical trial readouts, clinical trial initiations, and NDA filings over the remainder of this year and through 2023.”
Third Quarter 2022 Financial Highlights
1
Financial Guidance
Commercial Highlights
Sunosi
Auvelity
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.
2
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the 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.
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, 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).
3
Anticipated Milestones
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss third 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.
4
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 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.
5
Axsome Therapeutics, Inc.
Selected Consolidated Financial Data
Axsome Therapeutics, Inc.
Consolidated Balance Sheets
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
|
|
(Unaudited) |
|
|
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
227,520,218 |
|
|
$ |
86,472,854 |
|
Accounts receivables, net |
|
|
20,302,222 |
|
|
|
— |
|
Inventories, net |
|
|
2,103,477 |
|
|
|
— |
|
Prepaid and other current assets |
|
|
2,457,513 |
|
|
|
45,286 |
|
Total current assets |
|
|
252,383,430 |
|
|
|
86,518,140 |
|
Equipment, net |
|
|
626,990 |
|
|
|
283,846 |
|
Right-of-use asset - operating lease |
|
|
384,568 |
|
|
|
660,162 |
|
Goodwill |
|
|
11,897,000 |
|
|
|
— |
|
Intangible asset, net |
|
|
61,267,561 |
|
|
|
— |
|
Non-current inventory and other assets |
|
|
12,398,220 |
|
|
|
322,910 |
|
Total assets |
|
$ |
338,957,769 |
|
|
$ |
87,785,058 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
12,844,629 |
|
|
$ |
13,149,329 |
|
Accrued expenses and other current liabilities |
|
|
40,021,759 |
|
|
|
9,295,180 |
|
Operating lease liability, current portion |
|
|
416,876 |
|
|
|
620,675 |
|
Contingent consideration, current |
|
|
7,000,000 |
|
|
|
— |
|
Total current liabilities |
|
|
60,283,264 |
|
|
|
23,065,184 |
|
Contingent consideration, non-current |
|
|
27,400,000 |
|
|
|
— |
|
Loan payable, long-term |
|
|
93,913,159 |
|
|
|
49,089,522 |
|
Total liabilities |
|
|
181,596,423 |
|
|
|
72,154,706 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding at September 30, 2022 and December 31, 2021, respectively) |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value per share (150,000,000 shares authorized, 43,425,707 and 37,816,794 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively) |
|
|
4,342 |
|
|
|
3,782 |
|
Additional paid-in capital |
|
|
692,450,128 |
|
|
|
424,825,655 |
|
Accumulated deficit |
|
|
(535,093,124 |
) |
|
|
(409,199,085 |
) |
Total stockholders’ equity |
|
|
157,361,346 |
|
|
|
15,630,352 |
|
Total liabilities and stockholders’ equity |
|
$ |
338,957,769 |
|
|
$ |
87,785,058 |
|
6
Axsome Therapeutics, Inc.
Consolidated Statements of Operations
(Unaudited)
|
|
Three Months Ended |
|
|||||
|
|
September 30, |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Revenues: |
|
|
|
|
|
|
||
Product sales, net |
|
$ |
16,845,792 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
||
Cost of product sales |
|
|
1,923,831 |
|
|
|
— |
|
Research and development |
|
|
14,877,021 |
|
|
|
13,180,258 |
|
Selling, general and administrative |
|
|
40,892,443 |
|
|
|
20,226,884 |
|
Gain in fair value of contingent consideration |
|
|
(42,120 |
) |
|
|
— |
|
Intangible asset amortization |
|
|
1,606,789 |
|
|
|
— |
|
Total operating expenses |
|
|
59,257,964 |
|
|
|
33,407,142 |
|
Loss from operations |
|
|
(42,412,172 |
) |
|
|
(33,407,142 |
) |
Interest (expense), net |
|
|
(2,411,040 |
) |
|
|
(1,475,535 |
) |
Net loss |
|
$ |
(44,823,212 |
) |
|
$ |
(34,882,677 |
) |
Net loss per common share, basic and diluted |
|
$ |
(1.07 |
) |
|
$ |
(0.93 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
41,704,362 |
|
|
|
37,680,966 |
|
Axsome Contact:
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
7