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Axsome TherapeuticsC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-11
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Investor releaseQuarter not tagged2026-08-11

Axsome's Q2 Earnings Meet Estimates, Auvelity Drives Y/Y Revenues

Zacks
Axsome Therapeutics AXSM incurred a loss of 99 cents per share in the second quarter of 2026, which was in line with the Zacks Consensus Estimate. The company had reported a loss of 97 cents per share in the year-ago quarter. Axsome’s total revenues surged 46% year over year to $218.4 million in the second quarter. The increase in revenues was primarily driven by strong sales of lead drug Auvelity (AXS-05) as well as other marketed drugs. The top line, however, missed the Zacks Consensus Estimate of $225 million. Auvelity is approved for the treatment of major depressive disorder (MDD). In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies. Year to date, shares of Axsome have rallied 21% compared with the industry’s increase of 6.1%. Image Source: Zacks Investment Research Total revenues in the second quarter consisted of product revenues from Auvelity, Sunosi (solriamfetol) and Axsome’s newest drug, Symbravo (meloxicam and rizatriptan), as well as royalty and milestone revenues. Net product revenues were $216.4 million in the quarter, reflecting an increase of 45.2% year over year. Royalty and milestone revenues totaled $2 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories. Auvelity recorded sales of $180.3 million, up 51% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $175 million. Per Axsome, around 266,000 total prescriptions were recorded for Auvelity in the second quarter, reflecting a year-over-year increase of 34%. Sunosi’s net product sales were $35.8 million in the quarter, up 20% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year to 61,000. Sunosi sales beat the Zacks Consensus Estimate of $33.4 million. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in 2022. Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States. Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $2.3 million in the second quarter, down from $4.1 million recorded in the p…Read full document

Axsome Therapeutics AXSM incurred a loss of 99 cents per share in the second quarter of 2026, which was in line with the Zacks Consensus Estimate. The company had reported a loss of 97 cents per share in the year-ago quarter. Axsome’s total revenues surged 46% year over year to $218.4 million in the second quarter. The increase in revenues was primarily driven by strong sales of lead drug Auvelity (AXS-05) as well as other marketed drugs. The top line, however, missed the Zacks Consensus Estimate of $225 million. Auvelity is approved for the treatment of major depressive disorder (MDD). In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies. Year to date, shares of Axsome have rallied 21% compared with the industry’s increase of 6.1%. Image Source: Zacks Investment Research Total revenues in the second quarter consisted of product revenues from Auvelity, Sunosi (solriamfetol) and Axsome’s newest drug, Symbravo (meloxicam and rizatriptan), as well as royalty and milestone revenues. Net product revenues were $216.4 million in the quarter, reflecting an increase of 45.2% year over year. Royalty and milestone revenues totaled $2 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories. Auvelity recorded sales of $180.3 million, up 51% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $175 million. Per Axsome, around 266,000 total prescriptions were recorded for Auvelity in the second quarter, reflecting a year-over-year increase of 34%. Sunosi’s net product sales were $35.8 million in the quarter, up 20% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 14% year over year to 61,000. Sunosi sales beat the Zacks Consensus Estimate of $33.4 million. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in 2022. Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive a high single-digit royalty from AXSM on net sales of Sunosi in the United States. Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $2.3 million in the second quarter, down from $4.1 million recorded in the prior quarter. Symbravo’s sales missed the Zacks Consensus Estimate of $7.2 million. However, total prescriptions for Symbravo grew 30% sequentially to 23,500 in the second quarter of 2026. Research and development expenses (including stock-based compensation) were $46.2 million, down 6.7% from the year-ago quarter’s level, primarily due to lower costs related to Auvelity and AXS-14. Selling, general and administrative expenses (including stock-based compensation) totaled $208.1 million, up 59.7% year over year. The increase was due to higher commercial activities for Auvelity, including the ongoing pre-launch activities for the Alzheimer’s disease agitation indication and Symbravo. As of June 30, 2026, Axsome had cash and cash equivalents worth $319.9 million compared with $305.1 million as of March 31, 2026. Management believes that its cash balance as of June-end is sufficient to fund future operations into cash flow positivity. Axsome plans to initiate a pivotal phase II/III study of AXS-05 for treating smoking cessation later in the third quarter of 2026. Other pipeline candidates include AXS-12, AXS-14 and AXS-17, which target multiple central nervous system indications. In July 2026, the FDA accepted Axsome’s new drug application (NDA) seeking approval for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. With the FDA accepting the NDA for review, a decision from the regulatory body is expected on May 1, 2027. Axsome is evaluating the efficacy and safety of AXS-14 (esreboxetine) under the phase III FORWARD study for the management of fibromyalgia. AXS-17 is another pipeline asset of Axsome, which is being developed for epilepsy. The phase II study-enabling activities for AXS-17 in epilepsy are underway. The company plans to develop AXS-20 for schizophrenia and Tourette syndrome, with phase III study-enabling activities in schizophrenia currently underway. Axsome is advancing solriamfetol across multiple phase III studies for treating attention-deficit hyperactivity disorder (ADHD), MDD, binge eating disorder (BED) and shift work disorder (SWD). The company recently dosed the first patient in the phase III FOCUS-2 study and the phase III FOCUS-3 study evaluating solriamfetol for the treatment of ADHD in children and in adolescents, respectively. The phase III CLARITY study evaluating solriamfetol for the treatment of MDD patients with excessive daytime sleepiness symptoms began in February 2026. Top-line data from the ENGAGE study evaluating solriamfetol for treating BED is expected in the fourth quarter of 2026. Top-line data from the SUSTAIN study evaluating solriamfetol for treating SWD in adults is expected in 2027. Axsome Therapeutics, Inc. price-consensus-eps-surprise-chart | Axsome Therapeutics, Inc. Quote Axsome currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 0.4% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 163.9% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-10

Axsome Therapeutics Q2 Earnings Call Highlights

MarketBeat
Interested in Axsome Therapeutics, Inc.? Here are five stocks we like better. Q2 revenue rose 46% year over year to $218 million, led by AUVELITY sales of $180.3 million, while the net loss widened to $51.3 million. Axsome ended the quarter with approximately $320 million in cash and expects its existing funds to support operations through cash-flow positivity. AUVELITY demand continued to accelerate, including a 126% increase in new-to-brand prescriptions among patients aged 65 and older during the first eight weeks of its Alzheimer’s disease agitation launch. Overall prescriptions rose 34% year over year, supported by expanded sales coverage and 89% access to covered lives. The FDA accepted Axsome’s AXS-12 application for cataplexy in narcolepsy, with a target decision date of May 1, 2027. The company also expects to initiate a Phase II/III smoking-cessation trial for AXS-05 and said its late-stage pipeline could support roughly one new drug application annually through 2030. Biotech Is Heating Up—These 2 Red-Hot Stocks Stand Out Axsome Therapeutics (NASDAQ:AXSM) reported second-quarter 2026 net product revenue of $218 million, up 46% from a year earlier, as sales of AUVELITY and SUNOSI increased and prescription demand for SYMBRAVO continued to build. The company posted a net loss of $51.3 million, or $0.99 per share, compared with a net loss of $48 million, or $0.97 per share, in the second quarter of 2025. Axsome ended the quarter with approximately $320 million in cash and cash equivalents, versus $323 million at the end of 2025. → MarketBeat Week in Review – 08/03 - 08/07 5 medical stocks growing earnings by triple digits Chief Executive Officer Dr. Herriot Tabuteau said the quarter included commercial growth as well as regulatory and clinical progress across the company’s neuroscience pipeline. Axsome said it expects its existing cash balance to fund operations into cash-flow positivity. AUVELITY generated $180.3 million in quarterly net product sales, rising 51% year over year and 18% sequentially. SUNOSI contributed $35.8 million in revenue, including $33.8 million in net product sales, $1.5 million in royalty revenue from out-licensed territories and $500,000 in milestone revenue. → Quantum Earnings Week: Winners and Losers Are Finally Emerging Struggling Axsome Stock Could Bounce Back on Drug Trial Success SYMBRAVO recorded net product sales of $…Read full document

Interested in Axsome Therapeutics, Inc.? Here are five stocks we like better. Q2 revenue rose 46% year over year to $218 million, led by AUVELITY sales of $180.3 million, while the net loss widened to $51.3 million. Axsome ended the quarter with approximately $320 million in cash and expects its existing funds to support operations through cash-flow positivity. AUVELITY demand continued to accelerate, including a 126% increase in new-to-brand prescriptions among patients aged 65 and older during the first eight weeks of its Alzheimer’s disease agitation launch. Overall prescriptions rose 34% year over year, supported by expanded sales coverage and 89% access to covered lives. The FDA accepted Axsome’s AXS-12 application for cataplexy in narcolepsy, with a target decision date of May 1, 2027. The company also expects to initiate a Phase II/III smoking-cessation trial for AXS-05 and said its late-stage pipeline could support roughly one new drug application annually through 2030. Biotech Is Heating Up—These 2 Red-Hot Stocks Stand Out Axsome Therapeutics (NASDAQ:AXSM) reported second-quarter 2026 net product revenue of $218 million, up 46% from a year earlier, as sales of AUVELITY and SUNOSI increased and prescription demand for SYMBRAVO continued to build. The company posted a net loss of $51.3 million, or $0.99 per share, compared with a net loss of $48 million, or $0.97 per share, in the second quarter of 2025. Axsome ended the quarter with approximately $320 million in cash and cash equivalents, versus $323 million at the end of 2025. → MarketBeat Week in Review – 08/03 - 08/07 5 medical stocks growing earnings by triple digits Chief Executive Officer Dr. Herriot Tabuteau said the quarter included commercial growth as well as regulatory and clinical progress across the company’s neuroscience pipeline. Axsome said it expects its existing cash balance to fund operations into cash-flow positivity. AUVELITY generated $180.3 million in quarterly net product sales, rising 51% year over year and 18% sequentially. SUNOSI contributed $35.8 million in revenue, including $33.8 million in net product sales, $1.5 million in royalty revenue from out-licensed territories and $500,000 in milestone revenue. → Quantum Earnings Week: Winners and Losers Are Finally Emerging Struggling Axsome Stock Could Bounce Back on Drug Trial Success SYMBRAVO recorded net product sales of $2.3 million. While that was above the $400,000 reported in the prior-year quarter, it was down $1.8 million from the first quarter of 2026. Chief Financial Officer Nick Pizzie said the sequential decline primarily reflected a prior-period adjustment and greater use of the company’s patient-service program amid demand growth. SYMBRAVO’s gross-to-net discount reached the high-80% range during the quarter, a deviation from trend that Axsome expects to normalize for the remainder of the year. Gross-to-net discounts for AUVELITY and SUNOSI were each approximately 50%, with the company expecting improvement through the year. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War Cost of revenue was $13.6 million, or 6% of total net revenue. Research and development expense declined to $46.2 million from $49.5 million a year earlier, primarily due to lower costs associated with AXS-05 and AXS-14. Selling, general and administrative expense increased to $208.1 million from $130.3 million, driven mainly by commercialization activities for AUVELITY and SYMBRAVO. Axsome launched AUVELITY for Alzheimer’s disease agitation during the quarter and completed an expansion of its AUVELITY sales force. Chief Commercial Officer Ari Maizel said early launch measures pointed to accelerating demand. During the first eight weeks after the Alzheimer’s disease agitation launch, new-to-brand prescriptions among patients age 65 and older rose 126% compared with the same period in the prior quarter. Maizel said feedback from both community and long-term-care settings had been encouraging, though management said it was too early to provide more detailed metrics by setting of care. Overall AUVELITY new-to-brand prescriptions increased 26% from the first quarter, while total prescriptions reached roughly 266,000, up 34% year over year and 12% sequentially. Axsome said the broader antidepressant market grew 1% year over year and 2% sequentially over the same periods. The expanded sales organization activated more than 6,800 new AUVELITY prescribers during the quarter, a 21% increase from the prior quarter, bringing total unique prescribers since launch to approximately 69,000. Maizel said primary care was the predominant source of growth during the quarter, with growth also occurring in psychiatric specialties. AUVELITY coverage reached approximately 89% of total lives, including 82% of commercial lives and nearly all government-channel lives. The company said more than 75% of Alzheimer’s disease agitation patients do not require prior authorization, while acknowledging that requirements can vary by coverage plan. Axsome is using free samples in community settings to allow patients and care partners to begin titration before filling a prescription. Maizel said samples are not prescriptions and are not reflected in IQVIA prescription data. SYMBRAVO total prescriptions increased 30% sequentially to approximately 23,500. Axsome said its expansion to about 150 sales representatives was substantially complete and would support greater engagement with headache specialists and continued penetration in primary care. Payer coverage for SYMBRAVO was approximately 57% of lives across channels following the addition of about 17 million covered lives in the second quarter. The company expects coverage to improve further. SUNOSI produced approximately 61,000 total prescriptions, up 14% from a year earlier and 8% from the prior quarter. Axsome said the wake-promoting agent market declined 1% year over year and grew 2% sequentially. More than 17,000 clinicians have prescribed SUNOSI since launch, and payer coverage was approximately 82% across channels. The FDA accepted Axsome’s new drug application for AXS-12 for cataplexy in narcolepsy, setting a target action date of May 1, 2027. The company said AXS-12 has demonstrated onset of action at one week, durable efficacy data through six months, and potential effects on excessive daytime sleepiness and cognition, though it remains subject to FDA review. Axsome also said it remains on track to begin a Phase II/III trial of AXS-05 for smoking cessation during the current quarter. Its solriamfetol development program includes five ongoing Phase III trials across attention-deficit/hyperactivity disorder, binge eating disorder, major depressive disorder with excessive daytime sleepiness symptoms, and excessive daytime sleepiness associated with shift work disorder. Top-line results from the ENGAGE Phase III trial of solriamfetol in binge eating disorder are expected in the fourth quarter of 2026. Axsome recently initiated the FOCUS-2 and FOCUS-3 pediatric ADHD trials of solriamfetol. Enrollment continues in the FORWARD Phase III trial of AXS-14 for fibromyalgia. The company is advancing manufacturing work for AXS-20, or balipodect, ahead of a planned Phase III schizophrenia trial. Phase II-enabling work is also underway for AXS-17 in epilepsy. Tabuteau said the company’s late-stage pipeline could support, on average, one new NDA filing annually through 2030. Axsome Therapeutics, Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes. Axsome's pipeline includes several late-stage and approved product candidates. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Axsome Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-10

Axsome (AXSM) Reports Q2 Earnings: What Key Metrics Have to Say

Zacks
For the quarter ended June 2026, Axsome Therapeutics (AXSM) reported revenue of $218.38 million, up 45.5% over the same period last year. EPS came in at -$0.99, compared to -$0.92 in the year-ago quarter. The reported revenue represents a surprise of -2.74% over the Zacks Consensus Estimate of $224.52 million. With the consensus EPS estimate being -$0.99, the company has not delivered EPS surprise. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Axsome performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Product sales, net: $216.36 million versus $222.61 million estimated by six analysts on average. Compared to the year-ago quarter, this number represents a +45.2% change. Revenues- Royalty revenue and milestone revenue: $2.02 million versus $1.4 million estimated by five analysts on average. Compared to the year-ago quarter, this number represents a +86.5% change. Product Sales, net- SYMBRAVO: $2.3 million versus the four-analyst average estimate of $7.19 million. Product Sales, net- Auvelity: $180.3 million compared to the $174.71 million average estimate based on four analysts. The reported number represents a change of +50.8% year over year. Product Sales, net- Sunosi: $35.8 million versus the four-analyst average estimate of $33.79 million. The reported number represents a year-over-year change of +19.3%. View all Key Company Metrics for Axsome here>>> Shares of Axsome have returned -9% over the past month versus the Zacks S&P 500 composite's +3.4% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally p…Read full document

For the quarter ended June 2026, Axsome Therapeutics (AXSM) reported revenue of $218.38 million, up 45.5% over the same period last year. EPS came in at -$0.99, compared to -$0.92 in the year-ago quarter. The reported revenue represents a surprise of -2.74% over the Zacks Consensus Estimate of $224.52 million. With the consensus EPS estimate being -$0.99, the company has not delivered EPS surprise. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Axsome performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Product sales, net: $216.36 million versus $222.61 million estimated by six analysts on average. Compared to the year-ago quarter, this number represents a +45.2% change. Revenues- Royalty revenue and milestone revenue: $2.02 million versus $1.4 million estimated by five analysts on average. Compared to the year-ago quarter, this number represents a +86.5% change. Product Sales, net- SYMBRAVO: $2.3 million versus the four-analyst average estimate of $7.19 million. Product Sales, net- Auvelity: $180.3 million compared to the $174.71 million average estimate based on four analysts. The reported number represents a change of +50.8% year over year. Product Sales, net- Sunosi: $35.8 million versus the four-analyst average estimate of $33.79 million. The reported number represents a year-over-year change of +19.3%. View all Key Company Metrics for Axsome here>>> Shares of Axsome have returned -9% over the past month versus the Zacks S&P 500 composite's +3.4% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-10

Axsome: Q2 Earnings Snapshot

Associated Press

NEW YORK (AP) — NEW YORK (AP) — Axsome Therapeutics Inc. (AXSM) on Monday reported a loss of $51.3 million in its second quarter. The New York-based company said it had a loss of 99 cents per share. The results met Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was also for a loss of 99 cents per share. The biopharmaceutical company posted revenue of $218.4 million in the period, which did not meet Street forecasts. Seven analysts surveyed by Zacks expected $224.5 million. Axsome shares have risen 16% since the beginning of the year. The stock has more than doubled in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on AXSM at https://www.zacks.com/ap/AXSM

TranscriptFY2026 Q22026-08-10

FY2026 Q2 earnings call transcript

Earnings source - 93 paragraphs
Operator

Good morning, and welcome to the Axsome Therapeutics second quarter 2026 earnings conference call. My name is Kevin. I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, there'll be a question and answer session, and instructions will be given at that time. Please note this call is being recorded. I would now like to hand the call over to Ashley Dong, Senior Director of Investor Relations. Please go ahead, Ashley.

Ashley Dong

Thank you. Good morning, everyone, and welcome to Axsome's second quarter 2026 earnings conference call. Joining me today to discuss our results for the quarter are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, and Ari Maizel, Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdock, our General Counsel, will also be available for Q&A. Before we begin, I encourage everyone to visit the investors section of our website to find the press release and presentation for today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially.

Ashley Dong

Please refer to our SEC filings, including our quarterly and annual reports, for a description of these and other risks. You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements. With that, I'll hand it over to Herriot.

Herriot Tabuteau

Thank you, Ashley, and good morning, everyone. The second quarter was highly productive for Axsome as we grew our commercial business robustly and made important regulatory and clinical progress across our innovative neuroscience pipeline. In the second quarter, our commercial portfolio generated $218 million in net product revenue, a 46% increase year-over-year, driven by strong performance for AUVELITY and SUNOSI. In the quarter, we launched AUVELITY in Alzheimer's disease agitation and completed the expansion of the AUVELITY sales force. Early metrics for the sales force expansion and Alzheimer's disease agitation launch point to growth acceleration for AUVELITY. Underlying demand growth for SYMBRAVO is also accelerating, and we expect SUNOSI growth to continue outpacing the market, positioning us for continued strong growth across the entire commercial portfolio.

Herriot Tabuteau

Later in the call, Nick will comment further on our financials, and Ari will provide additional detail on our commercial performance, including early observations on the Alzheimer's disease agitation launch. During the quarter, we also advanced our leading neuroscience pipeline of six innovative product candidates, which we are developing for 10 serious conditions. Our broad late-stage neuroscience pipeline positions us to potentially file on average one new NDA each year between now and 2030, delivering potentially significant value to patients and stakeholders. Following Ari's remarks, I'll provide an update on each of these programs. With that, I'll turn the call over to Nick.

Nick Pizzie

Thanks, Herriot. Good morning, everyone. I'll begin with a review of our financial results for the quarter. Revenue increased to $218 million compared to $150 million in Q2 of 2025, representing a 46% year-over-year growth. Performance was driven by AUVELITY with steady growth from SUNOSI and continued strength in prescription demand for SYMBRAVO. We recorded net product sales for AUVELITY of $180.3 million in the quarter. That's a 51% increase compared to the second quarter of 2025 and an 18% increase quarter-over-quarter. SUNOSI net product revenue for the quarter was $35.8 million, representing a 20% year-over-year growth. SUNOSI revenue consisted of $33.8 million in net product sales, $1.5 million in royalty revenue associated with SUNOSI sales in out-licensed territories, and a half a million dollars in milestone revenue.

Nick Pizzie

Net sales for SYMBRAVO were $2.3 million in the quarter. SYMBRAVO was launched in June of 2025 and had net product sales of $400,000 for the second quarter of 2025. The decrease of $1.8 million in net sales from Q1 of 2026 primarily reflects a prior period adjustment and increased utilization of our patient service program driven by underlying demand growth. As such, SYMBRAVO gross and net discount deviated from trend during the quarter into the high 80% range. We anticipate SYMBRAVO GTN to return to prior levels for the remainder of the year. Gross and net discounts for AUVELITY and SUNOSI were each approximately 50% for the second quarter. We continue to anticipate gross and net discounts for both products to improve throughout the year, consistent with prior year trends.

Nick Pizzie

Turning to expenses, cost of revenue in the quarter was $13.6 million, representing 6% of total net revenue. Cost of revenue for the second quarter of 2025 was $13.4 million. Research and development expenses decreased to $46.2 million for the second quarter of 2026, compared to $49.5 million in the second quarter of 2025, which primarily reflects lower costs associated with AXS-05 and AXS-14. Selling, general, and administrative expenses in the quarter were $208.1 million compared to $130.3 million for the second quarter of last year. The increase was primarily driven by commercialization activities for AUVELITY and SYMBRAVO. Net loss for the quarter was $51.3 million, or $0.99 per share, compared to a net loss of $48 million, or $0.97 per share for the second quarter of 2025.

Nick Pizzie

Net loss in the quarter includes $27.1 million in stock-based compensation expense. We ended the quarter with approximately $320 million in cash and cash equivalents. This compares to $323 million as of end of 2025. We are seeing continued improvement in operating leverage while investing behind our key commercial opportunities and pipeline priorities. We continue to expect that our current cash balance is sufficient to fund anticipated operations into cash flow positivity. I'll turn the call over to Ari with a commercial update.

Ari Maizel

Thanks, Nick. During the second quarter, we saw strong underlying demand growth across our portfolio of three differentiated medicines. During the quarter, we further strengthened our commercial foundation, positioning us to drive growth across the portfolio over the balance of the year. AUVELITY. In the quarter, we launched AUVELITY in the Alzheimer's disease agitation market and completed the expansion of the AUVELITY sales force. I'm happy to share that early metrics indicate that these two developments are already beginning to have a meaningful impact on demand growth, positioning AUVELITY for continued momentum over the balance of the year. During the first eight weeks following the launch in this indication, new-to-brand prescriptions among patients 65 years of age and older increased 126% compared to the same period in the prior quarter, reflecting expanding adoption in this patient segment.

Ari Maizel

New-to-brand prescriptions represent new patients starting on AUVELITY for the first time and are considered a key leading indicator of growth. While it's early days in the commercialization of AUVELITY in Alzheimer's disease agitation, we are excited by the initial feedback that we have received from prescribers, which includes positive anecdotal evidence of AUVELITY's differentiated clinical profile reflected in real-world patient experience. Providers and care partners alike view the reduction in agitation symptoms and safety and tolerability profile favorably. These early experiences have reinforced our belief that AUVELITY has the potential to transform the treatment paradigm for Alzheimer's disease agitation. We look forward to sharing continued progress in the months ahead.

Ari Maizel

We are also beginning to see the early impact of our expanded sales organization, with overall new-to-brand prescriptions in the second quarter of 2026 increasing 26% compared to the first quarter of 2026. This momentum has continued into the third quarter. The expanded sales force activated more than 6,800 new AUVELITY prescribers in the quarter, representing 21% growth versus the previous quarter, bringing the total number of unique prescribers since launch to approximately 69,000. The inflection in new-to-brand prescriptions and increased velocity of new writer activation are strong leading indicators of our expanded sales force investment, resulted in market share gains for both new-to-brand and total prescriptions in the quarter. We expect these trends to continue to build in Q3 and Q4, translating into positive TRx trends, further market share penetration.

Ari Maizel

Total prescriptions for AUVELITY in the second quarter reached approximately 266,000, an increase of 34% year-over-year and 12% sequentially, substantially outpacing the antidepressant market, which grew 1% and 2% in the same time periods, respectively. In addition, AUVELITY market access continued to improve during the quarter, with coverage now at approximately 89% of total lives across channels, including 82% of commercial lives and approximately 100% of lives in the government channel. Our market access team is working closely with payers in both the commercial and government channels. We expect patient access for AUVELITY in both the MDD and ADA markets to continue to expand and evolve. Taken together, we expect the momentum from the sales force expansion, continued growth in MDD, and uptake in Alzheimer's disease agitation to drive continued growth over the rest of the year.

Ari Maizel

For SYMBRAVO, demand was strong, growing 30% quarter-over-quarter to approximately 23,500 total prescriptions. Prescriber and patient feedback continue to be very positive, supporting our commercial strategy to drive prescription volume while improving market access to support sustained growth over time. As mentioned on our prior earnings call, based on the strong demand for SYMBRAVO to date, our previously announced sales force expansion to approximately 150 sales representatives is substantially complete. Following the previously announced addition of approximately 17 million lives in Q2, overall payer coverage is now at approximately 57% of lives covered across channels, including approximately 56% of commercial lives and 57% of government lives. We expect coverage for SYMBRAVO to further improve moving forward. SUNOSI delivered another quarter of durable growth, with approximately 61,000 total prescriptions written during the quarter.

Ari Maizel

Representing 14% year-over-year growth and 8% sequential growth, compared to a 1% decline and 2% increase for the wake-promoting agent market in the same periods, respectively. More than 17,000 clinicians have now prescribed SUNOSI since launch. We continue to maintain broad payer coverage of approximately 82% of lives covered across all channels. Overall, the underlying commercial performance in Q2 reflects positive momentum for Axsome's portfolio of differentiated CNS products. Acceleration of AUVELITY in MDD and Alzheimer's disease agitation, continued market penetration for SYMBRAVO in migraine, and consistent growth from SUNOSI in EDS associated with narcolepsy and OSA position Axsome for a strong second half of 2026 and robust growth in the years ahead. I will now turn the call back to Herriot.

Herriot Tabuteau

Thank you, Ari. We are excited by our innovative neuroscience pipeline, which targets high unmet medical needs, novel indications, first-in-class mechanisms of action, and best-in-class profiles. I will now review the recent pipeline progress and discuss key upcoming clinical and regulatory milestones. In the quarter, the FDA accepted our NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy with a PDUFA target action date of May 1st, 2027. Based on its differentiated mechanism of action and resulting clinical profile, AXS-12 has the potential to provide a meaningful addition to the treatment armamentarium for patients living with narcolepsy, if approved. For AXS-05, the next indication under development is smoking cessation. We are on track to initiate our planned phase II/III trial in this indication this quarter.

Herriot Tabuteau

Exploring the full clinical potential of AXS-05 remains a top priority for us based on its unique pharmacology, which is potentially applicable across multiple neuropsychiatric disorders. With solriamfetol, our clinical programs across four new indications continue to advance. As a reminder, the new indications being explored are ADHD, binge eating disorder, MDD with excessive daytime sleepiness or EDS symptoms, and EDS associated with shift work disorder. All in all, we currently have five phase III trials underway across these indications. In ADHD, we recently initiated the FOCUS-2 and FOCUS-3 studies of solriamfetol in children and adolescents with ADHD. These studies use a parallel group design with a primary endpoint of change from baseline to week six in the ADHD Rating Scale.

Herriot Tabuteau

These two studies, if positive, together with the previously completed positive FOCUS phase III trial of solriamfetol in adults, would form the basis of an NDA filing for solriamfetol in the treatment of ADHD. In binge eating disorder, our ENGAGE phase III trial continues to enroll, and we anticipate top-line results from the study in the fourth quarter of this year. Our CLARITY phase III trial of solriamfetol in MDD with EDS, and our SUSTAIN phase III trial of solriamfetol in EDS associated with the shift work disorder are also advancing. For AXS-14, which we are developing for fibromyalgia, enrollment in our FORWARD phase III trial continues to progress. The FORWARD trial, if positive, together with the previously completed positive phase II and phase III trials, would support an NDA filing for AXS-14 for the treatment of fibromyalgia.

Herriot Tabuteau

With AXS-20, our first-in-class selective PDE10A inhibitor, we are making good progress in our chemistry, manufacturing, and controls activities with the goal of initiating a phase III trial with this molecule in schizophrenia. We are also advancing phase II-enabling activities for AXS-17, our GABA subtype selective PAM, which we are developing for epilepsy. In summary, we are excited by the programs in our leading neuroscience pipeline. Combined with building momentum in our existing commercial business, these programs, targeting areas of unmet medical need, lay the groundwork for continued growth and value creation for patients and stakeholders. I will now turn the call back to Ashley.

Ashley Dong

Thanks, Herriot. This concludes our prepared remarks and we'll now begin the Q&A session. To allow enough time for as many questions as possible, we kindly ask that you limit yourself to one question. Operator, please open the line.

Operator

Certainly. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. As a reminder, please ask one question, then return to the queue. Our first question today is coming from Leonid Timashev from RBC Capital Markets. Your line is now live.

Leonid Timashev

Hey, guys. Thanks for taking my question. Just one maybe on the Alzheimer's agitation launch, specifically as it relates to long-term care. Can you talk about the trends that you're seeing in the long-term care? The enthusiasm there given that it's a new area that you're launching into, sort of any successes or challenges that you're seeing there?

Ari Maizel

Thanks, Leo, for the question. As we stated earlier on the call, we're just eight weeks into the launch. We're really encouraged by some of the early data we're seeing. The early patient experience has been very promising. We're seeing strong growth in new-to-brand prescriptions in patients aged 65 and older. That feedback is consistent from both the community and long-term care settings.

Ari Maizel

Obviously, as we get further into the launch, we'll be able to share some additional details around specific settings of care. We've been really encouraged by what we're seeing across both LTC and community.

Operator

Thank you. Our next question is coming from Malcolm Hoffman from BMO Capital Markets. Your line is now live.

Malcolm Hoffman

Hi. Thanks for taking our question. You highlighted some pretty strong growth in NBRX for AUVELITY in the 65-plus patient group there. Can you maybe break this out further to indicate how much of this may be driven by agitation versus MDD expansion as well? Thanks.

Ari Maizel

Yeah, thanks so much for the question. As we mentioned on the call, NBRX growth was very positive, 26% versus Q1. We are seeing meaningful increases in both MDD and Alzheimer's disease agitation, which we would expect to continue moving forward.

Operator

Thank you. Our next question is coming from [crosstalk] I'm sorry.

Malcolm Hoffman

Go ahead.

Operator

Our next question is coming from Ash Verma from UBS. Your line is now live.

Ash Verma

Hey, guys. Thanks for taking my questions. Congrats on the progress here. Maybe just on Alzheimer's agitation, can you talk about the level of sampling that you need to do early in the launch? As the time progresses, would that gradually be lower? Is this sampling going to be more or less than the MDD launch that you did? Just help us understand so that we can correlate to data that we are seeing at our end at the third-party sources. Thanks.

Ari Maizel

Yeah. As it relates to sampling, particularly in a community setting, sampling is important to gain trial with patients. We've been committed as an organization to ensure that patients are appropriately titrated based on the approved dosage and administration. I think it's a little too early for us to indicate how sampling will change over time, but right now we're very pleased with the strong demand for samples. It's been applauded by the clinical community in order to get patients started effectively and to give them the best chance for the clinical profile that we saw in our phase III clinical trials.

Operator

Thank you. Next question is coming from Rudy Li from Wolfe Research. Your line is now live.

Rudy Li

Hey, thanks for taking my question. For ADA, can you provide more color on the capture rates of like IQVIA of the prescription data for the titration package, what additional key commercial metric you'll be monitoring to track the progress? Thank you.

Ari Maizel

Yeah, I would say on the capture rate for the titration pack specifically, there's really limited data, we'll learn more as we get further into the launch. In terms of ongoing performance data, I think obviously sharing information about adoption or utilization with patients who are 65 years and older was an important signal for this particular call. As we get more data into the launch, I think we'll update based on the most relevant trends related to the launch.

Operator

Thank you. Our next question is coming from Marc Goodman from Leerink Partners. Your line is now live.

Marc Goodman

Nick, can you talk about where you think AUVELITY gross nets will settle out in, let's say, two years after both of these indications are kind of going. Just for depression alone, first line, second line, what % are we up to now? Thanks.

Nick Pizzie

Sure. Hey, Marc. Maybe first, where we were for AUVELITY and GTN for this quarter, we were around 50%, as I shared in the opening remarks. That's obviously with the increase in covered lives and also with improving the quality of coverage to first line or first switch. As you allude to, in a couple of years, we anticipate Medicare scripts to become as a higher proportion of scripts compared to commercial. What we've shared longer term is that we would anticipate GTN to remain in the 50s. We'll be able to give better guidance probably towards the end of the year as we see this launch grow in ADA.

Ari Maizel

As it relates to first, second line use, in this quarter, we saw about more than half of patients, 56% were treated in a first or second line setting. As we've shared previously, we don't have a particular % in mind. We know that AUVELITY has been effective in patients as early as treatment naive and as late as treatment experienced. We're very comfortable with what we've seen over the past few years, and it's certainly supporting continued growth in both MDD and Alzheimer's agitation.

Operator

Thank you. Our next question is coming from Ami Fadia from Needham & Company. Your line is now live.

Ami Fadia

Hi, good morning. Thanks for taking my question. Maybe if you can talk about some of the market dynamics with SYMBRAVO and talk about the evolution of the adoption rate there and how you see that progressing over the coming months. Thank you.

Ari Maizel

Yeah, thanks for the question. I mean, we're very pleased with the underlying demand for SYMBRAVO. As we stated earlier, it grew 30% versus Q1. We're receiving very positive feedback from both patients and providers around SYMBRAVO's clinical profile and impact on patients. We expect that to continue. We mentioned that our sales force is expanding to approximately 150 sales representatives. That will enable us not only to call on higher decile headache specialists with more frequency, but also continue to expand and penetrate the primary care setting, which has been a key source of growth over the past several quarters.

Operator

Thank you. Our next question today is coming from Andrew Tsai from Jefferies. Your line is now live.

Matt Barcus

Hey. Good morning and congrats on the quarter. This is Matt Barcus on for Andrew Tsai. I just want to ask, can you confirm what the exact percentage of your Alzheimer's agitation scripts or samples right now? Since samples tend to run out in two to three weeks, any patient in June, July, a sample should be converting to an actual patient by now, you think? Is the total AUVELITY weekly script growth in the last couple of weeks representative of the weekly growth profile that could be going forward? Would you absolutely expect a faster cadence in August and September compared to June and July?

Ari Maizel

Yeah. Thanks for the question. We don't share specific details regarding sampling as a proportion of overall demand, but we've been very pleased with the overall demand for samples in the community setting. Again, think that that's a very important aspect of the launch to support effective titration for elderly patients. In terms of weekly growth, as we mentioned, we've got eight weeks of data that we're sharing today. We expect to learn much more in the coming months related to the launch, but we've been very pleased with the early indicators.

Operator

Thank you. Our next question is coming from Pete Stavropoulos from Cantor Fitzgerald. Your line is now live.

Pete Stavropoulos

Good morning and congrats on the quarter. Thank you for taking my question. For AXS-12, reboxetine. There was the first approval of an orexin-2 receptor agonist last week. How do you think about the underlying commercial opportunity for reboxetine in the narcolepsy market that has this new class of drug approved? Also, have you had discussions with payers around the profile of AXS-12 and possible pricing?

Herriot Tabuteau

Great. Thanks for the question. I'll take the first part of that question, and Ari can take the second part. If you look at the narcolepsy market, we know that it is characterized by a lot of heterogeneity in the narcolepsy patient population. More treatment options are better for patients. We're excited by the potential for AXS-12 to provide a new and differentiated treatment option for patients living with narcolepsy. If you think about it mechanistically, it works on the orexin pathway. Orexin stimulates the locus coeruleus to produce norepinephrine, and AXS-12 also stimulates norepinephrine production. What we like about AXS-12 clinically are a few things. One, it works very quickly. We have onset of action, which is demonstrated at one week. Secondly, the efficacy is durable. We have data out to six months. If you look at the side effect profile, it is very favorable.

Herriot Tabuteau

You combine that with a first-in-class mechanism of action for narcolepsy. Also, you look at the clinical data, which shows that there is the potential to affect EDS as well as cognition. We're very excited by the potential to provide a new treatment option for patients, and we think that that will be welcome in the marketplace.

Ari Maizel

Yeah. Regarding your question about market access, we've had very productive conversations with payers as they're learning more about AXS-12, and obviously there's a lot of interest in narcolepsy. We won't comment on pricing until closer to the launch, but we feel very optimistic about the potential for patient access for AXS-12.

Operator

Thank you. Next question today is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live.

Ram Selvaraju

Thanks so much for taking our question. Congrats on the quarter. Just wanted to see how you're thinking about the relative positioning of balipodect in schizophrenia, and if you are thinking about specific treatment combinations positioning as adjunct treatment versus standalone, and what the prospects are for applicability of this drug in neuropsych indications beyond schizophrenia down the road. Thank you.

Herriot Tabuteau

Sure. Thanks, Ram, for the question. We're really excited by the prospects for balipodect in schizophrenia. Right now, what we're doing is we are conducting chemistry manufacturing and controlled activities to enable the start of a phase III trial in schizophrenia. Stay tuned. That work is well underway, and that is a priority for that program. Other indications that we're looking at are Tourette syndrome. We've stated that we do intend to initiate a phase II trial in that indication also. That molecule and the clinical programs are progressing. As it relates to how it would be used, either as monotherapy or with other products, it's too early. We want to do the experiment, and that is the phase III trial. We are encouraged by the results of the phase II trial, which was conducted in this patient population, which showed a very significant treatment effect.

Herriot Tabuteau

If you look at the product as well as a favorable side effect profile, which dovetails very nicely with the unique mechanism of action of the product.

Operator

Thank you. Our next question today is coming from David Amsellem from Piper Sandler. Your line is now live.

David Amsellem

Thanks. On ADA, and I know these are early days, but do you have a good read regarding how the drug is being used relative to reuptake inhibitors? Are you seeing usage in frontline or downstream of reuptake inhibitors that historically have been used off-label in ADA, or maybe a mix of both? Just wondering if you have a sense of where the usage mix is falling again in these early days. Thank you.

Ari Maizel

Thanks for the question, David. I think the data is limited at this point regarding where patients are coming from, if they're switching from SSRIs, SNRIs, atypical antipsychotics. The line of treatment, we'll learn more as the launch progresses. I would say in general, the anecdotal feedback we're getting is that the drug is working per the label, meaning that we're seeing a rapid onset of action, a reduction in both the severity and frequency of symptoms, and the safety tolerability profile has been viewed favorably by both HCPs and care partners alike. I think we'll learn more in the coming weeks and months about line of usage and where the patients are coming from. We're very pleased with the early response we're hearing.

Operator

Thank you. Next question is coming from Jason Gerberry from Bank of America. Your line is now live.

Jason Gerberry

Hey, guys. Thanks for taking my question. It sounds like some impressive physician or prescriber expansion metrics, I think plus 6,500, I think I heard. That, I guess, breadth of prescriber expansion, how much of that is just neurologists, someone who's maybe more of a unique prescriber to ADA versus, say, primary care, a type of prescriber that might be prescribing AUVELITY across both indications? I don't know if you have a sense of, as you're seeing that prescriber base expand, if it's more just breaking into the newer prescribers unique for ADA, or if you're getting prescribers who could potentially drive growth in both indications. Thanks.

Ari Maizel

Thanks, Jason. I think for the Q2 data, it's largely related to our sales force expansion, and we're very pleased with those early signals as it relates to new writer activation and obviously NBRX or new-to-brand prescription growth, which largely is coming from the sales force expansion and predominantly from growth within the MDD indication. For this particular quarter, I would say neuros may not be representative necessarily. Primary care is the predominant growth driver within Q2 data specifically. Obviously, as the launch progresses in Alzheimer's agitation, we would expect to see more specialists adopt. For this particular quarter, I would say that really nice growth in the psych specialties, but faster growth within primary care.

Operator

Thank you. Our next question is coming from Sean Laaman from Morgan Stanley Investment Management. Your line is now live.

Sean Laaman

Good morning. Thanks for taking my question. Hope everyone's well. Just thinking to your peak revenue assumptions for AUVELITY. Which of these would have the greatest impact among prescriber activation, long-term care penetration, treatment duration, payer access, and market expansion into previously untreated patients? Which has the greatest sensitivity?

Ari Maizel

Thanks for the question. I think all of those things are important. Obviously, we'll be focused on all aspects in accelerating new writer activation. I think new-to-brand prescriptions are a really important leading indicator of long-term growth potential, that's a key area of focus. As we've demonstrated our ability to expand market access and payer coverage for our brands has also been very positive. I would say it's difficult to pick just one of the elements that you're describing. From a commercial perspective, we're focused on improving execution across the board.

Operator

Thank you. Next question today is coming from Brian Skorney from Baird. Your line is now live.

Brian Skorney

Hey, good morning, everyone. Thanks for taking my question. I was hoping you could help us think through a little more on the sampling impact in the early days of the Alzheimer's agitation launch. Are these free samples at point of care? Is this primarily a coupon card that's issued at point of care or online and turned in at the pharmacy that covers the full cost of treatment? Just trying to think, would it be reasonable to assume most of the NBRXs in Alzheimer's agitation right now are free samples? For a Medicare patient, would the goal be to have them on commercial at the first refill? Do you see sampling as a bridge to securing best coverage for the patient, or is it to getting over initial abandonment of the new prescription over the copay? Thanks.

Ari Maizel

Yeah. Thanks for the question, Brian. When we refer to sampling, we're primarily talking about free samples, a trial offer that is provided to community-based settings where the clinicians are able to give a sample to a patient or care partner during an office visit. It's an important aspect of any launch in order to encourage trial and to really give early patient experience with the product. As you can imagine, in the Alzheimer's population, there's a heightened sensitivity just to the patients and safety tolerability aspects. This gives them a chance to see how the drug performs in advance of a first prescription. We expect to continue to sample as appropriate.

Ari Maizel

It's been applauded by the clinician community primarily because it allows the patient to go home with the titration doses in order to get up to steady state on the maintenance dose when they're home. I think we'll have more to share down the road as we see more data related to sample conversion. I would just say that samples are not prescriptions, they're not showing up in the IQVIA data. That's an important factor as you think about it.

Operator

Thank you. Next question is coming from Joseph Thome from TD Cowen. Your line is now live.

Joseph Thome

Hi there. Good morning, and thank you for taking my question. Maybe on binge eating disorder, can you comment on the clinically meaningful result that you're looking for later this year on reduction in episodes? Is it just that sig and placebo response in binge eating disorder studies can sometimes be reasonably high, especially if the patient population maybe isn't severe enough. Can you comment on your overall level of comfort with the patient population that you did enroll in this trial? Thank you.

Herriot Tabuteau

We're very comfortable with the patient population. We think that we designed a study, and we were enrolling patients that are appropriate to be studied in a clinical trial in binge eating disorder. As it relates to bogies, we don't have any. We designed the study, we've powered it for statistical significance, and that's what we're looking for.

Operator

Thank you. Next question is coming from Ben Burnett from Wells Fargo. Your line is now live.

Ben Burnett

Hi, good morning. I also wanted to ask about AUVELITY and the new-to-brand growth rate that you mentioned, the 26% quarter-over-quarter. Just wanted to see if we could get maybe a little bit more context for this number. How does this number compare to the prior period in Q1? Just based on what you're seeing, what kind of growth should we be thinking about in Q3? Thank you.

Ari Maizel

Thanks for the question. Regarding the new-to-brand growth rate, I think one thing that could be helpful, in the first quarter, we saw essentially equivalent growth from both a total prescriptions and a new-to-brand prescriptions perspective. In Q2, we saw a step-up in growth, 26% with new-to-brand prescriptions and 12% for total prescriptions. I think that's a strong signal of the impact of our sales force expansion in the quarter, we would expect that to continue to build into the second half of the year.

Operator

Thank you. Our next question is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live.

Graig Suvannavejh

Hey, good morning. Thanks for taking my questions. It's really related to how we should all think about Alzheimer's disease agitation and uptake there. Trying to get a sense of if you could provide some color on how we should think about the smoothness of the uptake, do you anticipate that whether it's due to the sales force expansion or just greater awareness, that there will be a sharp inflection, whether there are formulary approval dynamics, anything that could give us a better sense of how we should think about the uptake over the next several quarters or year for that matter? Thanks.

Ari Maizel

Yeah. Thanks, Graig. I think a couple points I'd point to. Number one, we expanded the sales force, and in the quarter, we saw meaningful acceleration in new-to-brand prescriptions and new writer activation. As you know, with eight weeks of launch data in Alzheimer's agitation, the majority of that growth came from MDD. We expect MDD to grow as Alzheimer's agitation launch is ramping up. I think we'll have more to say, obviously, with more data on the Alzheimer's launch. The early indicators are very promising. I think it's premature to say exactly what the inflection will look like, but the early signals that we shared earlier, including the NBRX growth, the positive clinical experience we've received, the growth in patients 65 and older, all point to very strong leading indicators that we expect to build throughout the rest of the year.

Operator

Okay. The next question is coming from David Hoang from Deutsche Bank. Your line is now live.

David Hoang

Hi there. Thanks for taking my questions. I want to ask a little bit about any, let's say, qualitative commentary you may be getting from your field force about how docs are thinking about the decision for a branded product in Alzheimer's agitation. Obviously, there is the Rexulti is the other approved product out there. Any color commentary on how docs are approaching AUVELITY versus Rexulti would be helpful. Are you hearing anything in terms of step edits or prior authorization that payers are asking for ADA? Thank you.

Ari Maizel

Yeah. Thanks, David. I think, first of all, there's still significant need for provider education in the Alzheimer's disease agitation market. This is a market that did not have any approved products just a couple of years ago. There's still some education required, which we've been really proud to be a part of. Treatment intervention has often been reserved for more severe forms of agitation, particularly in primary care, and so that's been a point of education regarding the benefits and rationale for earlier innovation. As it relates to branded products, I think ultimately, providers want to help patients, and there has not been anything approved with this type of profile historically, and so there's a lot of interest in learning more about the clinical profile, both from an efficacy, safety tolerability standpoint.

Ari Maizel

The leading indicators, I think, are very promising in that regard. From an access standpoint, we're really pleased with the coverage that we had at launch, a 100% coverage in the Medicare channel. More than 75% of patients do not require a PA. Of course, PAs can still pop up depending on the patient's coverage. In terms of step edits, by and large, we're very pleased that patients will gain access to AUVELITY based on their prior treatment experience or based on the coverage that they have. All of those things really point to continued progress in the launch moving forward, and we'll obviously share more updates as we get more data moving forward.

Operator

Thank you. The next question is coming from Yatin Suneja from Guggenheim. Your line is now live.

Speaker 22

Hi, this is Eddie on for Yatin. Thanks for taking our question. Acknowledging it's still very early, what are prescribers telling you about early patient response and continuation on AUVELITY in ADA? Are you picking up any differences by prescriber setting, just in terms of how they're monitoring or plan to monitor and follow up with patients as they get treated? Thanks.

Ari Maizel

Thanks for the question, Eddie. The response has been really consistent regardless of setting of care or specialty. That is that AUVELITY has been effective at reducing both the frequency and severity of agitation symptoms with a favorable safety tolerability profile. We'll obviously learn more as the launch progresses, but so far it's been very consistent, both in terms of specialists as well as setting of care.

Operator

Thank you. Next question is coming from Madison Elsaadi from B. Riley Securities. Your line is now live.

Madison Elsaadi

Good morning, guys. Thanks for taking our question. Maybe on the 2Q revenue, how much of that reflects any channel stocking versus dispense demand? Sorry if I missed it. If you could just help clarify the underlying operating cash burn, if you strip working capital and everything away, just asking in the context of your path to breakeven. Thanks.

Nick Pizzie

Sure, Madison. First off, the full revenue this quarter was related to demand. There was no stocking at the end of the quarter. We continue to be roughly at two weeks of inventory on hand, no change as it relates to that. If you take a look at our cash burn for the quarter, it was somewhere in the neighborhood of $24 million, $25 million, taking the net loss and backing out the majority of the non-cash loss is related to stock-based comp, more than half of that. You're in the neighborhood of the low to mid-20s from a cash burn.

Nick Pizzie

What we've shared is that our SG&A for the remainder of the year is we would anticipate it to essentially plateau to where we are this quarter in Q2 of $208 million as we're fully staffed and built a foundation for AUVELITY as well as SYMBRAVO. R&D will continue to tick up as we've commenced the ADHD trials. Importantly, we should see operating leverage continue in the back half of the year. We saw that this quarter with revenues growing at 14% and OPEX growing at 7%.

Operator

Thank you. Our next question is coming from Myles Minter from William Blair. Your line is now live.

Speaker 24

Hey, team, this is John on for Myles. Thanks so much for taking our question. I was wondering if you can give us any updated plans for the DTC campaign for AUVELITY with the ongoing launch in AD agitation. Thanks.

Ari Maizel

Yeah. Thanks, John. Obviously, DTC is an important part of our marketing mix, and we've been pleased with the impact of our direct-to-consumer investments across really all of our brands, but AUVELITY specifically over the past year or so. Given that it's still only eight weeks into the launch, we're assessing the potential for a more substantial DTC effort. Right now, we are investing in consumer marketing, primarily focused on care partners. The potential for something more broad reaching, like TV or video advertising, is something that we'll continue to evaluate as the launch progresses.

Operator

Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over for any further closing comments.

Herriot Tabuteau

Well, thank you. Our Axsome business advanced significantly in the second quarter. Our commercial strategy is translating into growing adoption of our medicines. Our pipeline continues to progress towards multiple milestones with substantial value creation potential. Our strong financial position allows us to continue investing behind our strategic priorities to maximize the long-term potential of our portfolio of medicines. We are excited for the remainder of the year and look forward to sharing updates on our progress. Thank you all for joining us, and have a great day.

Operator

Thank you. That does conclude today's teleconference webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

Investor releaseQuarter not tagged2026-08-06

Alpha Cognition Inc. (ACOG) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release

Zacks
Alpha Cognition Inc. (ACOG) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 13. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.39 per share in its upcoming report, which represents a year-over-year change of +40%. Revenues are expected to be $4.32 million, up 160.2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 11.49% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant fo…Read full document

Alpha Cognition Inc. (ACOG) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 13. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.39 per share in its upcoming report, which represents a year-over-year change of +40%. Revenues are expected to be $4.32 million, up 160.2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 11.49% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Alpha Cognition Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +6.90%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Alpha Cognition Inc. will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Alpha Cognition Inc. would post a loss of$0.41 per share when it actually produced a loss of -$0.37, delivering a surprise of +9.76%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Alpha Cognition Inc. appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Axsome Therapeutics (AXSM), is soon expected to post loss of $0.99 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -7.6%. Revenues for the quarter are expected to be $224.52 million, up 49.6% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Axsome has been revised 14.8% down to the current level. Nevertheless, the company now has an Earnings ESP of +12.69%, reflecting a higher Most Accurate Estimate. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that Axsome will beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alpha Cognition Inc. (ACOG) : Free Stock Analysis Report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-05

Countdown to Axsome (AXSM) Q2 Earnings: Wall Street Forecasts for Key Metrics

Zacks
Wall Street analysts forecast that Axsome Therapeutics (AXSM) will report quarterly loss of -$0.99 per share in its upcoming release, pointing to a year-over-year decline of 7.6%. It is anticipated that revenues will amount to $224.52 million, exhibiting an increase of 49.6% compared to the year-ago quarter. The consensus EPS estimate for the quarter has undergone a downward revision of 14.8% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have reassessed their initial estimates during this timeframe. Before a company reveals its earnings, it is vital to take into account any changes in earnings projections. These revisions play a pivotal role in predicting the possible reactions of investors toward the stock. Multiple empirical studies have consistently shown a strong association between trends in earnings estimates and the short-term price movements of a stock. While investors typically rely on consensus earnings and revenue estimates to gauge how the business may have fared during the quarter, examining analysts' projections for some of the company's key metrics often helps gain a deeper insight. Given this perspective, it's time to examine the average forecasts of specific Axsome metrics that are routinely monitored and predicted by Wall Street analysts. Based on the collective assessment of analysts, 'Revenues- Product sales, net' should arrive at $222.61 million. The estimate suggests a change of +49.4% year over year. Analysts forecast 'Product Sales, net- Auvelity' to reach $174.71 million. The estimate indicates a year-over-year change of +46.1%. Analysts expect 'Product Sales, net- Sunosi' to come in at $33.79 million. The estimate suggests a change of +12.6% year over year. View all Key Company Metrics for Axsome here>>> Shares of Axsome have demonstrated returns of -15.1% over the past month compared to the Zacks S&P 500 composite's +3.5% change. With a Zacks Rank #4 (Sell), AXSM is expected to lag the overall market performance in the near future. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> . Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zac…Read full document

Wall Street analysts forecast that Axsome Therapeutics (AXSM) will report quarterly loss of -$0.99 per share in its upcoming release, pointing to a year-over-year decline of 7.6%. It is anticipated that revenues will amount to $224.52 million, exhibiting an increase of 49.6% compared to the year-ago quarter. The consensus EPS estimate for the quarter has undergone a downward revision of 14.8% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have reassessed their initial estimates during this timeframe. Before a company reveals its earnings, it is vital to take into account any changes in earnings projections. These revisions play a pivotal role in predicting the possible reactions of investors toward the stock. Multiple empirical studies have consistently shown a strong association between trends in earnings estimates and the short-term price movements of a stock. While investors typically rely on consensus earnings and revenue estimates to gauge how the business may have fared during the quarter, examining analysts' projections for some of the company's key metrics often helps gain a deeper insight. Given this perspective, it's time to examine the average forecasts of specific Axsome metrics that are routinely monitored and predicted by Wall Street analysts. Based on the collective assessment of analysts, 'Revenues- Product sales, net' should arrive at $222.61 million. The estimate suggests a change of +49.4% year over year. Analysts forecast 'Product Sales, net- Auvelity' to reach $174.71 million. The estimate indicates a year-over-year change of +46.1%. Analysts expect 'Product Sales, net- Sunosi' to come in at $33.79 million. The estimate suggests a change of +12.6% year over year. View all Key Company Metrics for Axsome here>>> Shares of Axsome have demonstrated returns of -15.1% over the past month compared to the Zacks S&P 500 composite's +3.5% change. With a Zacks Rank #4 (Sell), AXSM is expected to lag the overall market performance in the near future. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> . Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-03

Analysts Estimate Axsome Therapeutics (AXSM) to Report a Decline in Earnings: What to Look Out for

Zacks
The market expects Axsome Therapeutics (AXSM) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 10. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This biopharmaceutical company is expected to post quarterly loss of $0.99 per share in its upcoming report, which represents a year-over-year change of -7.6%. Revenues are expected to be $224.52 million, up 49.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 14.78% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's pr…Read full document

The market expects Axsome Therapeutics (AXSM) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 10. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This biopharmaceutical company is expected to post quarterly loss of $0.99 per share in its upcoming report, which represents a year-over-year change of -7.6%. Revenues are expected to be $224.52 million, up 49.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 14.78% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Axsome, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +12.69%. On the other hand, the stock currently carries a Zacks Rank of #4. So, this combination makes it difficult to conclusively predict that Axsome will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Axsome would post a loss of$0.85 per share when it actually produced a loss of -$1.26, delivering a surprise of -48.24%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Axsome doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Cytokinetics (CYTK), is soon expected to post loss of $1.63 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -45.5%. This quarter's revenue is expected to be $20.42 million, down 69.4% from the year-ago quarter. The consensus EPS estimate for Cytokinetics has been revised 0.3% higher over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +2.07%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP indicates that Cytokinetics will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report Cytokinetics, Incorporated (CYTK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-14

Axsome Therapeutics to Report Second Quarter 2026 Financial Results on August 10

GlobeNewswire
NEW YORK, July 14, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the second quarter of 2026 on Monday, August 10, 2026, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. A replay of the conference call will be available on the Company’s website for approximately 30 days following the live event. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple early- to late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company 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 stat…Read full document

NEW YORK, July 14, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the second quarter of 2026 on Monday, August 10, 2026, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. A replay of the conference call will be available on the Company’s website for approximately 30 days following the live event. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple early- to late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company 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 commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s 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 the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; 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 Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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 commercialization of SUNOSI, AUVELITY, and SYMBRAVO 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; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, 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 circumstances. Investors:Ashley DongSenior Director, Investor Relations(929) [email protected] Media:Darren OplandSenior Director, Corporate Communications(929) [email protected]

Investor releaseQuarter not tagged2026-06-05

Why Is Mirum Pharmaceuticals (MIRM) Down 10.1% Since Last Earnings Report?

Zacks
It has been about a month since the last earnings report for Mirum Pharmaceuticals, Inc. (MIRM). Shares have lost about 10.1% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Mirum Pharmaceuticals due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Mirum incurred a loss of 39 cents per share (excluding certain one-time expenses) in the first quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 40 cents. The company reported a loss of 30 cents per share in the year-ago quarter. Revenues in the first quarter totaled $159.9 million, up 43.3% year over year. The figure also beat the Zacks Consensus Estimate of $148 million. The top line was driven by the strong growth of Livmarli and bile acid medicines, Cholbam and Ctexli. Livmarli’s net product sales were $113.8 million in the first quarter, reflecting an increase of 55% year over year. Livmarli sales in the United States were $84 million, reflecting strong demand across all indications. In ex-U.S. markets, Livmarli sales were $30 million. Net product sales of bile acid products, comprising Cholbam and Ctexli tablets, were $46.1 million in the first quarter, reflecting an increase of 20% year over year. The company did not record any license and other revenues in the reported quarter. Research and development expenses increased almost 138.8% year over year to $97.9 million. Selling, general and administrative expenses totaled $96.3 million, up almost 66.9% from the year-ago quarter’s level. As of March 31, 2026, Mirum had cash, cash equivalents and investments worth $420.6 million compared with $391.4 million as of Dec. 31, 2025. Reflecting the strong performance of its marketed products, Mirum raised the full-year revenue guidance for 2026. The company now expects worldwide net product sales of approximately $660-$680 million in 2026, compared with the previous expectation of $630-$650 million. It turns out, estimates review have trended downward during the past month. The consensus estimate has shifted -41.47% due to these changes. At this time, Mirum Pharmaceuticals has a poor Growth Score of F, however its Mom…Read full document

It has been about a month since the last earnings report for Mirum Pharmaceuticals, Inc. (MIRM). Shares have lost about 10.1% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Mirum Pharmaceuticals due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Mirum incurred a loss of 39 cents per share (excluding certain one-time expenses) in the first quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 40 cents. The company reported a loss of 30 cents per share in the year-ago quarter. Revenues in the first quarter totaled $159.9 million, up 43.3% year over year. The figure also beat the Zacks Consensus Estimate of $148 million. The top line was driven by the strong growth of Livmarli and bile acid medicines, Cholbam and Ctexli. Livmarli’s net product sales were $113.8 million in the first quarter, reflecting an increase of 55% year over year. Livmarli sales in the United States were $84 million, reflecting strong demand across all indications. In ex-U.S. markets, Livmarli sales were $30 million. Net product sales of bile acid products, comprising Cholbam and Ctexli tablets, were $46.1 million in the first quarter, reflecting an increase of 20% year over year. The company did not record any license and other revenues in the reported quarter. Research and development expenses increased almost 138.8% year over year to $97.9 million. Selling, general and administrative expenses totaled $96.3 million, up almost 66.9% from the year-ago quarter’s level. As of March 31, 2026, Mirum had cash, cash equivalents and investments worth $420.6 million compared with $391.4 million as of Dec. 31, 2025. Reflecting the strong performance of its marketed products, Mirum raised the full-year revenue guidance for 2026. The company now expects worldwide net product sales of approximately $660-$680 million in 2026, compared with the previous expectation of $630-$650 million. It turns out, estimates review have trended downward during the past month. The consensus estimate has shifted -41.47% due to these changes. At this time, Mirum Pharmaceuticals has a poor Growth Score of F, however its Momentum Score is doing a bit better with a D. Following the exact same course, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Mirum Pharmaceuticals has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Mirum Pharmaceuticals belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Axsome Therapeutics (AXSM), has gained 5.1% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. Axsome reported revenues of $191.2 million in the last reported quarter, representing a year-over-year change of +57.4%. EPS of -$1.26 for the same period compares with -$0.80 a year ago. Axsome is expected to post a loss of $0.83 per share for the current quarter, representing a year-over-year change of +9.8%. Over the last 30 days, the Zacks Consensus Estimate remained unchanged. Axsome has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Mirum Pharmaceuticals, Inc. (MIRM) : Free Stock Analysis Report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-06-04

Why Is Ocugen (OCGN) Down 10.7% Since Last Earnings Report?

Zacks
A month has gone by since the last earnings report for Ocugen (OCGN). Shares have lost about 10.7% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Ocugen due for a breakout? Well, first let's take a quick look at its latest earnings report in order to get a better handle on the recent catalysts for Ocugen, Inc. before we dive into how investors and analysts have reacted as of late. Ocugen incurred a loss of 6 cents per share in the first quarter of 2026, wider than the Zacks Consensus Estimate as well as the year-ago loss of 5 cents. Ocugen’s total revenues rose 3.5% year over year to $1.5 million in the first quarter, beating the Zacks Consensus Estimate of $1 million. The company’s top line currently comprises only collaboration revenues Ocugen’s operating expenses increased during the quarter as the company accelerated clinical development and commercial preparation activities. Research and development expenses were $11.3 million, up 18.1% from the year-ago quarter’s level. General and administrative expenses totaled $8.1 million, up 25.8% year over year. The company raised $37.5 million in gross proceeds during the first quarter of 2026, including $15 million from investors exercising their warrants. As a result, its cash, cash equivalents, and restricted cash increased to $32.2 million as of March 31, 2026, up from $18.9 million at the end of 2025. Following the $115 million offering of convertible senior notes, the company expects to have approximately $112.1 million in cash, cash equivalents, and restricted cash when the transaction closes, which includes the Avenue debt payoff. Since the earnings release, investors have witnessed a upward trend in fresh estimates. The consensus estimate has shifted 6.25% due to these changes. At this time, Ocugen has a subpar Growth Score of D, a score with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a score of F on the value side, putting it in the fifth quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising.…Read full document

A month has gone by since the last earnings report for Ocugen (OCGN). Shares have lost about 10.7% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Ocugen due for a breakout? Well, first let's take a quick look at its latest earnings report in order to get a better handle on the recent catalysts for Ocugen, Inc. before we dive into how investors and analysts have reacted as of late. Ocugen incurred a loss of 6 cents per share in the first quarter of 2026, wider than the Zacks Consensus Estimate as well as the year-ago loss of 5 cents. Ocugen’s total revenues rose 3.5% year over year to $1.5 million in the first quarter, beating the Zacks Consensus Estimate of $1 million. The company’s top line currently comprises only collaboration revenues Ocugen’s operating expenses increased during the quarter as the company accelerated clinical development and commercial preparation activities. Research and development expenses were $11.3 million, up 18.1% from the year-ago quarter’s level. General and administrative expenses totaled $8.1 million, up 25.8% year over year. The company raised $37.5 million in gross proceeds during the first quarter of 2026, including $15 million from investors exercising their warrants. As a result, its cash, cash equivalents, and restricted cash increased to $32.2 million as of March 31, 2026, up from $18.9 million at the end of 2025. Following the $115 million offering of convertible senior notes, the company expects to have approximately $112.1 million in cash, cash equivalents, and restricted cash when the transaction closes, which includes the Avenue debt payoff. Since the earnings release, investors have witnessed a upward trend in fresh estimates. The consensus estimate has shifted 6.25% due to these changes. At this time, Ocugen has a subpar Growth Score of D, a score with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a score of F on the value side, putting it in the fifth quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Ocugen has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Ocugen is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Axsome Therapeutics (AXSM), a stock from the same industry, has gained 4.9%. The company reported its results for the quarter ended March 2026 more than a month ago. Axsome reported revenues of $191.2 million in the last reported quarter, representing a year-over-year change of +57.4%. EPS of -$1.26 for the same period compares with -$0.80 a year ago. Axsome is expected to post a loss of $0.83 per share for the current quarter, representing a year-over-year change of +9.8%. Over the last 30 days, the Zacks Consensus Estimate has changed -15.5%. Axsome has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ocugen, Inc. (OCGN) : Free Stock Analysis Report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-06-03

Why Is Axsome (AXSM) Down 0.4% Since Last Earnings Report?

Zacks
It has been about a month since the last earnings report for Axsome Therapeutics (AXSM). Shares have lost about 0.4% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Axsome due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Axsome incurred a loss of $1.26 per share in the first quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 85 cents. The company had reported a loss of $1.22 per share in the year-ago quarter. Axsome’s total revenues surged 57.4% year over year to $191.2 million in the first quarter, beating the Zacks Consensus Estimate of $189 million. The year-over-year increase in revenues was primarily driven by strong sales of Auvelity as well as other marketed drugs. Total revenues in the first quarter consisted of product revenues from Auvelity, Sunosi, and the newest drug, Symbravo, as well as royalty and milestone revenues. Net product revenues were $189.4 million in the quarter, reflecting an increase of 57.4% year over year. Royalty and milestone revenues totaled $1.8 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories. Auvelity recorded sales of $153.2 million, up 59% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $144 million. Per Axsome, around 223,000 prescriptions were recorded for Auvelity in the first quarter, reflecting a year-over-year increase of 35%. Sunosi’s net product sales were $33.9 million in the quarter, up 34% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 16% year over year to 54,000. Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $4.1 million in the first quarter and were flat sequentially. Symbravo’s sales missed the Zacks Consensus Estimate of $6.7 million. Total prescriptions for Symbravo grew 36% sequentially to 17,000 in the first quarter of 2026. Research and development expenses (including stock-based compensation) were $52.7 million, up 17.6% from the year-ago quarter’s level, due to a one-time acquisition-related expense. Selling, gen…Read full document

It has been about a month since the last earnings report for Axsome Therapeutics (AXSM). Shares have lost about 0.4% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Axsome due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Axsome incurred a loss of $1.26 per share in the first quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 85 cents. The company had reported a loss of $1.22 per share in the year-ago quarter. Axsome’s total revenues surged 57.4% year over year to $191.2 million in the first quarter, beating the Zacks Consensus Estimate of $189 million. The year-over-year increase in revenues was primarily driven by strong sales of Auvelity as well as other marketed drugs. Total revenues in the first quarter consisted of product revenues from Auvelity, Sunosi, and the newest drug, Symbravo, as well as royalty and milestone revenues. Net product revenues were $189.4 million in the quarter, reflecting an increase of 57.4% year over year. Royalty and milestone revenues totaled $1.8 million in the quarter, reflecting royalties on Sunosi’s sales in out-licensed territories. Auvelity recorded sales of $153.2 million, up 59% from the year-ago quarter’s level. Sales of the drug beat the Zacks Consensus Estimate of $144 million. Per Axsome, around 223,000 prescriptions were recorded for Auvelity in the first quarter, reflecting a year-over-year increase of 35%. Sunosi’s net product sales were $33.9 million in the quarter, up 34% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 16% year over year to 54,000. Axsome’s newest drug, Symbravo, was launched in June 2025 in the United States. Sales of the drug came in at $4.1 million in the first quarter and were flat sequentially. Symbravo’s sales missed the Zacks Consensus Estimate of $6.7 million. Total prescriptions for Symbravo grew 36% sequentially to 17,000 in the first quarter of 2026. Research and development expenses (including stock-based compensation) were $52.7 million, up 17.6% from the year-ago quarter’s level, due to a one-time acquisition-related expense. Selling, general and administrative expenses (including stock-based compensation) totaled $185 million, up 53.1% year over year. The increase was due to higher commercial activities for Auvelity and Symbravo, and also the ongoing pre-launch activities for Auvelity for the Alzheimer’s disease agitation indication. As of March 31, 2026, Axsome had cash and cash equivalents worth $305.1 million compared with $322.9 million as of Dec. 31, 2025. In the past month, investors have witnessed a downward trend in estimates revision. The consensus estimate has shifted -69.78% due to these changes. At this time, Axsome has a great Growth Score of A, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of C. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Axsome has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Axsome Therapeutics, Inc. (AXSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook