Bornholm Eye Disease

The FDA Office of Generic Drugs reported 956 generic drug approvals in 2023. Credit: FG Trade via Getty Images The US Food and Drug Administration (FDA) Office of Generic Drugs has reported improvements in the number of generic drugs approved in its 2023 Annual Report, and detailed deficiencies that applicants needed to resolve before an approval could be made. Alongside this, the agency highlighted several actions that were made to fulfil its bid to improve generic medicine access. The recent report highlighted that the FDA approved 956 generic drugs and issued 1,493 complete response letters last year, an improvement on 2022’s 914 approvals and 1,775 complete response letters. Significant approvals in 2023 included the approval of numerous first generics of Takeda Pharmaceuticals’ Vyvanse (lisdexamfetamine dimesylate), a treatment for attention deficit hyperactivity disorder (ADHD) in patients six years and older and for moderate to severe binge eating disorder (BED) in adults. The agency also approved the first generic of Pfizer ’s Xeljanz (tofacitinib citrate), an oral solution for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis amongst other conditions. As of 1 January 2024, Vyvanse has had a wholesale price of $1,292.61 per 100ct bottle of the 10mg oral capsules. According to GlobalData, the branded 200ml 1mg/ml oral solution for Xeljanz wholesales at $5,552.58. See Also: FDA to decide on Sanofi/Regeneron’s Dupixent for COPD in June Moderna reports net loss of $4.7bn for full year 2023 GlobalData is the parent company of Pharmaceutical Technology. In recent years, the FDA has made larger efforts to encourage the development of generic medicines. In 2023, the organisation gave approximately $20m to fund science and research projects. It also expanded the responsibilities of the Generic Drug User Fee Act (GDUFA)-funded Center for Research on Complex Generics (CRCG) to improve research collaborations between the FDA, academic institutions, and the generic industry. In the same year, the FDA’s Office of Generic Drugs (OGD) also issued 12 policy documents to aid drug manufacturers in the development of generic drugs. As of this year, the agency has continued with these developments, announcing its partnership with the European Medicines Agency (EMA) on 8 February. The two organisations have expanded the 2005 collaborative parallel scientific advice (PSA) programme, which gave sponsors a direct route to discuss scientific matters related to product development with regulators. The regulators extended the programme, allowing sponsors to continue engaging with regulators earlier in the development process. In the 22 February report, OGD director Dr Lilun Murphy said: “OGD will continue to focus on matters such as operational modernisation, workforce excellence, communication through conferences and education, direct engagement with companies developing generic drugs, and the meeting of our overall GDUFA programme goals.”

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 Total net product revenues were $71.5 million and $204.9 million for the fourth quarter and full year of 2023, representing year-over-year growth of 193% and 309%, respectively. Total product revenues for the comparable periods in 2022 were $24.4 million and $50.0 million, respectively. Total revenue for the full year of 2023 was $270.6 million, which includes license revenue of $65.7 million from out-licensing Sunosi® in certain ex-U.S. territories.Auvelity® net product sales were $49.0 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch. Auvelity was launched on October 19, 2022, and had U.S. net sales of $5.2 million for the fourth quarter of 2022.Sunosi net product revenues were $22.5 million and $74.8 million for the fourth quarter and full year of 2023, representing 17% and 67% year-over-year growth, respectively, consisting of $21.7 million and $72.4 million in net product sales and $0.8 million and $2.4 million in royalty revenue associated with Sunosi sales in out-licensed territories, respectively. Sunosi net sales for the comparable periods in 2022 were $19.2 million and $44.9 million, respectively. The U.S. portion of the acquisition of Sunosi closed in May 2022 and the ex-U.S. portion closed in November of 2022. Total Sunosi revenue for the full year of 2023 was $140.5 million, which includes license revenue of $65.7 million from out-licensing Sunosi in certain ex-U.S. territories.Total costs of revenue were $7.4 million and $26.1 million for the fourth quarter and full year of 2023, respectively. Total costs of revenue for the comparable periods in 2022 was $2.3 million and $5.2 million, respectively. Total cost of revenue for the full year of 2023 included a one-time cost of $5.0 million associated with the upfront fee received for the Sunosi out licensing transaction.Research and development (R&D) expenses were $30.8 million and $97.9 million for the fourth quarter and full year of 2023, respectively, compared to $14.7 million and $57.9 million for the comparable periods in 2022, respectively. The increase was primarily related to the FOCUS trial of solriamfetol in ADHD, the advancement of ongoing trials of AXS-05 and AXS-12, manufacturing costs associated with the anticipated NDAs for AXS-07 and AXS-14, post-marketing commitments for Auvelity and Sunosi, and higher personnel costs, including non-cash stock-based compensation.Selling, general, and administrative (SG&A) expenses were $86.8 million and $323.1 million for the fourth quarter and full year of 2023, respectively, compared to $61.5 million and $159.3 million for the comparable periods in 2022, respectively. The increase was primarily related to commercialization activities for Auvelity and Sunosi, including sales force and marketing expenses, and higher personnel costs related to organizational growth, including non-cash stock-based compensation.Net loss for the fourth quarter of 2023 was $98.7 million or $(2.08) per share, compared to a net loss of $61.2 million, or $(1.41) per share, for the comparable period in 2022. The net loss in the fourth quarter of 2023 includes $63.7 million in non-cash charges, comprised of $43.2 million in acquisition-related contingent consideration expense reflecting updated sales projections for the recently announced new indications in solriamfetol, $18.9 million of non-cash stock-based compensation expense, and $1.6 million of non-cash intangible asset amortization. Net loss was $239.2 million, or $(5.27) per share, for the full year of 2023, compared to a net loss of $187.1 million, or $(4.60) per share, for the full year of 2022. The net loss for the full year includes total non-cash charges of $117.9 million which includes $62.6 million of stock-based compensation expense, $48.9 million in fair value of contingent consideration expense, and $6.4 million in intangible amortization compared to $37.7 million, $3.3 million, and $4.1 million respectively for the full year 2022.Cash and cash equivalents totaled $386.2 million at December 31, 2023, compared to $200.8 million at December 31, 2022.Shares of common stock outstanding were 47,351,363 at December 31, 2023. Financial Guidance Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. Commercial Highlights Auvelity Approximately 84,000 prescriptions were written for Auvelity in the fourth quarter of 2023, representing a 23% sequential increase versus the third quarter of 2023.The previously announced expansion of the Auvelity neuropsychiatry sales force from 162 to 260 representatives is now complete. The sales force expansion along with Axsome’s pioneering, technology-driven Digital Centric Commercialization (DCC™) platform is expected to increase our reach to approximately 44,000 health care providers, who write nearly 90% of new branded antidepressant prescriptions.Payer coverage for Auvelity across all channels is stable at approximately 70% of all covered lives. Commercial coverage is at approximately 48%, and Auvelity is a protected class product which must be covered by all payors in the Medicare channel and is covered by all state Medicaid programs. Axsome expects coverage to continue to expand and evolve. Sunosi Approximately 42,000 prescriptions were written for Sunosi in the U.S. in the fourth quarter of 2023, representing an 18% increase versus the fourth quarter of 2022 and a 2% sequential increase versus the third quarter of 2023. Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently 83% of total lives across all channels are covered. 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. Alzheimer’s Disease 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 anticipated enrollment trends and recent changes to treatment market dynamics, the Company now anticipates completion of ADVANCE-2 in the second half of 2024.Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial in this indication in 2024. AXS-07 AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine. Migraine: Manufacturing activities related to the planned resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine continue to progress. The Company continues to anticipate resubmission of the NDA in the first half of 2024. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review. 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. Narcolepsy: Enrollment in the SYMPHONY study, a Phase 3 randomized, multicenter, double-blind, placebo-controlled, parallel-group trial of AXS-12 in the treatment of narcolepsy has been completed. The Company is on track to announce topline results for SYMPHONY in the first quarter of 2024. 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. Fibromyalgia: Axsome is compiling the NDA for AXS-14 for the management of fibromyalgia. The Company is on track to submit the NDA in the first half of 2024. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the management of fibromyalgia. 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). Attention Deficit Hyperactivity Disorder: Axsome is conducting the FOCUS study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of ADHD in adults. The Company anticipates topline results from the FOCUS trial in the second half of 2024.Major Depressive Disorder: The Company plans to initiate a Phase 3 trial of solriamfetol for the treatment of MDD in the first quarter of 2024.Binge Eating Disorder: The Company plans to initiate a Phase 3 trial of solriamfetol for the treatment of BED in the first quarter of 2024.Shift Work Disorder: The Company plans to initiate a Phase 3 trial of solriamfetol for the treatment of excessive sleepiness (ES) associated with SWD in the first quarter of 2024. Anticipated Milestones Regulatory and Commercial: AXS-07 for migraine, NDA resubmission (1H 2024)AXS-14 for fibromyalgia, NDA submission (1H 2024) Clinical Trial Topline Results: Phase 3 SYMPHONY trial of AXS-12 in narcolepsy (1Q 2024)Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (2H 2024)Phase 3 FOCUS trial of solriamfetol in attention deficit hyperactivity disorder (ADHD) in adults (2H 2024) Clinical Trial Initiations: Phase 3 trial of solriamfetol in major depressive disorder (MDD) (1Q 2024)Phase 3 trial of solriamfetol for binge eating disorder (BED) (1Q 2024)Phase 3 trial of solriamfetol in shift work disorder (SWD) (1Q 2024)Pivotal Phase 2/3 trial of AXS-05 for smoking cessation (2024) 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 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. 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 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

Preliminary total 4Q and full year 2023 net product revenue of $71 million and $204 million, respectively Auvelity preliminary 4Q and full year 2023 net product sales of $49 million and $130 million, respectively Sunosi preliminary 4Q and full year 2023 net product revenue of $22 million and $74 million, respectively 2024 anticipated regulatory milestones include NDA submission for AXS-14 in fibromyalgia and NDA resubmission for AXS-07 in migraine 2024 anticipated clinical trial readouts include topline results of the SYMPHONY trial in narcolepsy, ADVANCE-2 trial in Alzheimer’s disease agitation, and the FOCUS Phase 3 trial in ADHD 2024 anticipated trial initiations include Phase 3 trials of solriamfetol in major depressive disorder, binge eating disorder, and shift work disorder NEW YORK, Jan. 04, 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 preliminary net product revenue for the fourth quarter and full year ended December 31, 2023. “Axsome completed its first full year as a commercial company in 2023 and, during that time, our medicines reached approximately 100,000 unique patients. Prescriptions for Auvelity and Sunosi totaled more than 236,000 and 139,000, respectively for the full year,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Looking ahead, 2024 promises to be a busy year for us with an increased field force effort that will support continued strong commercial execution with Auvelity and Sunosi. We also anticipate multiple important clinical and regulatory milestones from our industry leading neuroscience portfolio in 2024. These include topline results from Phase 3 trials in narcolepsy, Alzheimer’s disease agitation, and ADHD, NDA resubmission and submission for migraine and fibromyalgia, respectively, and initiation of Phase 3 trials in major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder. Collectively, Axsome has the potential to address conditions that impact the lives of more than 150 million patients in the U.S. We are committed to developing and delivering innovative treatments with novel mechanisms of action to address unmet medical needs in serious conditions that affect brain health.” Preliminary Fourth Quarter and Full Year 2023 Net Product Revenue (Unaudited) Based on preliminary unaudited financial information, Axsome expects total product revenue to be approximately $71 million and $204 million for the fourth quarter and full year of 2023, respectively. Auvelity® net product sales are expected to be approximately $49 million and $130 million for the fourth quarter and full year of 2023, respectively.Sunosi® net product revenue is expected to be $22 million and $74 million for the fourth quarter and full year of 2023, respectively. Net product revenue excludes $66 million in license revenue recognized by Axsome in the first quarter of 2023. The foregoing information reflects the Company's estimate with respect to net product revenue for Auvelity and Sunosi based on currently available unaudited information. This announcement is not a comprehensive statement of Axsome’s financial results and is subject to completion of Axsome’s financial closing procedures. Axsome’s final financial results will be issued upon completion of its closing procedures and may vary from these preliminary estimates. 2024 Development Pipeline Anticipated Milestones Axsome is advancing an industry-leading neuroscience portfolio encompassing five innovative late-stage product candidates for 10 serious conditions, which affect more than 150 million people in the U.S. alone. 2024 anticipated milestones for key pipeline programs are summarized below. Regulatory Milestones: AXS-07 for migraine, NDA resubmission (1H 2024)AXS-14 for fibromyalgia, NDA submission (1Q 2024) Clinical Trial Topline Results: Phase 3 SYMPHONY trial of AXS-12 in narcolepsy (1Q 2024)Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (1H 2024)Phase 3 FOCUS trial of solriamfetol in attention deficit hyperactivity disorder (ADHD) in adults (2H 2024) Clinical Trial Initiations: Phase 3 trial of solriamfetol in major depressive disorder (MDD) (1Q 2024)Phase 3 trial of solriamfetol for binge eating disorder (BED) (1Q 2024)Phase 3 trial of solriamfetol in shift work disorder (SWD) (1Q 2024)Pivotal Phase 2/3 trial of AXS-05 for smoking cessation (2024) About AUVELITY® AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of Auvelity in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if Auvelity is safe and effective for use in children.Auvelity is not approved for uses other than the treatment of MDD. The ingredients in Auvelity, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? Auvelity and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Auvelity is not for use in children.You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: suicidal thoughts or actionsnew or worsening depression or anxietyagitation or restlessnesstrouble sleeping (insomnia)acting aggressive, being angry violentan extreme increase in activity and talking (mania)panic attacksnew or worsening irritabilityacting on dangerous impulsesother unusual changes in behavior or mood Do not take Auvelity if you: have or had a seizure disorder.have or had an eating disorder like anorexia or bulimia.have recently and suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or anti-seizure medicines, and you have recently suddenly stopped taking them.are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI in the last 14 days, or are being treated with the antibiotic linezolid or intravenous methylene blue. Ask your HCP or pharmacist if you are unsure whether you take an MAOI. Do not start taking an MAOI until you have stopped taking Auvelity for at least 14 days.are allergic to dextromethorphan, bupropion, or any other ingredients in Auvelity. Auvelity may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with Auvelity. The risk is higher if you take higher doses of Auvelity, have certain medical problems, or take Auvelity with certain other medicines. Do not take Auvelity with other medicines unless your healthcare provider tells you to.If you have a seizure during treatment with Auvelity, stop taking Auvelity and call your HCP right away. Do not take Auvelity again if you have a seizure.Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with Auvelity. Your HCP should check your blood pressure before you start taking and during treatment with Auvelity. Manic episodes. Manic episodes may happen in people with bipolar disorder who take Auvelity. Symptoms may include: greatly increased energyracing thoughtsunusually grand ideastalking more or faster than usualsevere trouble sleepingreckless behaviorexcessive happiness or irritability Unusual thoughts or behaviors. One of the ingredients in Auvelity (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). Auvelity may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. Auvelity may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Auvelity with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: agitationhallucinationsconfusioncomafast heartbeatblood pressure changesdizzinesssweatingflushinghigh body temperature (hyperthermia)shaking (tremors), stiff muscles, or muscle twitchingloss of coordinationseizuresnausea, vomiting, diarrhea COMMON SIDE EFFECTS The most common side effects of Auvelity include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.These are not all the possible side effects of Auvelity. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. BEFORE USING Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.It is important to tell your HCP if you are taking: other medicines containing bupropion or dextromethorphanmedicines to treat depression, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressantstheophyllinecorticosteroidsoral diabetes medicines or use insulin to control your blood sugarmedicines to control appetite (anorectic)nicotine medicines to help you stop smokingstreet (illicit) drugsbenzodiazepines, sedative-hypnotic (sleep medicines), or opiates If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take Auvelity with your other medicines.Tell your HCP if you are pregnant or plan to become pregnant. Auvelity may harm your unborn baby if you take it during pregnancy. Auvelity is not recommended during pregnancy. Your HCP will prescribe another treatment for females who plan to become pregnant.One of the ingredients in Auvelity passes into your breast milk. Do not breastfeed during treatment with Auvelity and for 5 days after the final dose. Tell your HCP about all your medical conditions, including if you: have problems with your liver or kidneys.have diabetes, heart disease, or high blood pressure.have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.have a history of alcohol or drug abuse.have a history of seizure, eating disorder, or abuse alcohol or drugs.have low blood sugar, low blood sodium levels, or a history of falls.you take certain other medicines that could interact with Auvelity.have or had a condition known as bipolar disorder, a family history of bipolar disorder, suicide, or depression.have high pressure in the eye (glaucoma). Review the list below with your HCP. Auvelity may not be right for you if: you drink a lot of alcohol.you abuse prescription or street drugs.you are pregnant or plan to become pregnant.you are breastfeeding or plan to breastfeed. HOW TO TAKE Auvelity is available by prescription only.Take Auvelity exactly as instructed by your HCP.Take Auvelity 1 time a day for 3 days, then increase your dose to 2 times a day (taken at least 8 hours apart). Do not take more than 2 Auvelity tablets in 24 hours.If you miss a dose, do not take an extra dose. Wait and take your next dose at the regular time. Do not take more than 1 dose of Auvelity at a time.Do not change your dose or stop taking Auvelity without talking to your HCP.Swallow Auvelity tablets whole. Do not crush, chew, or divide the tablets.Do not give Auvelity to other people.If you take too much Auvelity call your HCP or seek medical advice promptly. LEARN MORE For more information about Auvelity, call 866-496-2976 or visit Auvelity.com. This summary provides basic information about Auvelity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about Auvelity and how to take it. Your HCP is the best person to help you decide if Auvelity is right for you. AUV CON BS 10/2022 Please see full Prescribing Information, including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide. About Sunosi® (solriamfetol) Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Sunosi does not treat the underlying cause of OSA and Sunosi does not take the place of any device prescribed for OSA, such as a continuous positive airway pressure (CPAP) machine. It is important that you continue to use these treatments as prescribed by your healthcare provider. Sunosi received U.S. Food and Drug Administration approval on March 20, 2019 to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States. Sunosi is protected by a robust patent estate with expiries out to 2042. More information about Sunosi, including Full Prescribing Information and Medication Guide, is available here. Important Safety Information Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you: have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol.have had a heart attack or a stroke.have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction.are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI. Do not take SUNOSI if you are taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). What are the possible side effects of SUNOSI? SUNOSI may cause serious side effects, including: Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before, and during, treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop any of these symptoms. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI. The most common side effects of SUNOSI include: headachedecreased appetiteproblems sleepingnauseaanxiety These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects. SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (CIV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see here for full Prescribing Information. SUN CON ISI 05/2022 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; differences between the Company’s 2023 preliminary financial information disclosed herein as compared to the Company’s final 2023 audited financial statements; delays with respect to the Company’s 2024 anticipated milestones; 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. Axsome Contacts: Investors:Mark JacobsonChief Operating OfficerAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com www.axsome.com Media: Darren OplandDirector, Corporate CommunicationsAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com