Full Press Release Details
Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones
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. 4, 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:
oAXS-07 for migraine, NDA resubmission (1H 2024)
oAXS-14 for fibromyalgia, NDA submission (1Q 2024)
-Clinical Trial Topline Results:
oPhase 3 SYMPHONY trial of AXS-12 in narcolepsy (1Q 2024)
oPhase 3 ADVANCE-2 trial of AXS-05 for Alzheimer's disease agitation (1H 2024)
oPhase 3 FOCUS trial of solriamfetol in attention deficit hyperactivity disorder (ADHD) in adults (2H 2024)
-Clinical Trial Initiations:
oPhase 3 trial of solriamfetol in major depressive disorder (MDD) (1Q 2024)
oPhase 3 trial of solriamfetol for binge eating disorder (BED) (1Q 2024)
oPhase 3 trial of solriamfetol in shift work disorder (SWD) (1Q 2024)
oPivotal Phase 2/3 trial of AXS-05 for smoking cessation (2024)
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 actions
-new or worsening depression or anxiety
-agitation or restlessness
-trouble sleeping (insomnia)
-acting aggressive, being angry violent
-an extreme increase in activity and talking (mania)
-new or worsening irritability
-acting on dangerous impulses
-other 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 energy
-unusually grand ideas
-talking more or faster than usual
-severe trouble sleeping
-excessive 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:
-blood pressure changes
-high body temperature (hyperthermia)
-shaking (tremors), stiff muscles, or muscle twitching
-loss of coordination
-nausea, vomiting, diarrhea
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.
-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:
oother medicines containing bupropion or dextromethorphan
omedicines to treat depression, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants
ooral diabetes medicines or use insulin to control your blood sugar
omedicines to control appetite (anorectic)
onicotine medicines to help you stop smoking
ostreet (illicit) drugs
obenzodiazepines, 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.
-Auvelity is available by prescription only.