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Axsome Therapeutics, Inc. (AXSM - Free Report) incurred an adjusted loss 22 cents per share in the first quarter of 2023, narrower than the Zacks Consensus Estimate and our model estimate of a loss of $1.13 and $1.15, respectively. AXSM had reported a loss of $1.03 per share in the year-ago period.
The company’s $94.6 million revenues beat the Zacks Consensus Estimate and our model estimate of $27 million and $25.2 million, respectively. Axsome did not generate any revenue in the year-ago quarter due to the absence of a marketed product.
Revenues mainly benefitted from Sunosi ex-U.S. license agreement upfront payment received in the quarter.
Quarter in Detail
Net product revenues were $28.6 million in the quarter. Total revenues consist of product revenues from Sunosi (sleep drug), Auvelity (major depressive disorder drug), licensing and royalty revenues.
Auvelity recorded its first full-quarter sales of $15.7 million, up 302% from the previous quarter. There were no net sales in the comparable period. Auvelity is Axsome’s first drug approved by the FDA in August 2021 and launched in October 2022.
Sunosi net product sales were $12.9 million for the first quarter of 2023. There were no net sales in the comparable period for Sunosi. Total prescriptions for Sunosi increased 4% from the previous quarter.
Axsome acquired the U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. Axsome began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. Jazz received approval for Sunosi as a treatment for narcolepsy in 2019. JAZZ is entitled to receive high-single-digit royalty on U.S. net sales of Sunosi.
Axsome’s shares were up 5.5% on May 8, probably as Auvelity sales beat investor expectations. Shares of Axsome have gained 0.8% in the year-to-date period against the industry’s 5.5% decline.
Image Source: Zacks Investment Research
Licensing revenues were $65.7 million in the first quarter, representing an upfront payment from Pharmanovia for Sunosi commercialization rights in Europe, and other Middle East and North African countries.
Royalty revenues were $0.3 million for the quarter, reflecting Sunosi sales in the out-licensed territories.
Research and development expenses were $17.8 million in the quarter, up 41% from the year-ago period. The increase was due to higher costs associated with clinical studies and post-marketing commitments for Sunosi and Auvelity.
Selling, general and administrative expenses were $74.2 million, up 289% year over year. The significant increase was due to higher commercial activities for Sunosi and Auvelity, which included sales force onboarding and marketing spending.
As of Mar 31, 2023, Axsome had cash and cash equivalents worth $246.5 million compared with $200.8 million as of Dec 31, 2022.
2023 Guidance
Management believes that its cash balance of 246.5 million (as of March 2023 end) and its $350-million term-loan facility will be enough to fund future operations into cash flow positivity.
Pipeline Updates
Several label expansion studies on Auvelity are underway for the treatment of other CNS disorders. Axsome is evaluating Auvelityin a phase III study, ACCORD, for treating agitation associated with Alzheimer’s Disease (AD). Axsome plans to start a pivotal phase II/III study evaluation of Auvelity for smoking cessation by the fourth quarter of 2023.
The company is also conducting the ADVANCE-2 study, a parallel group trial, to assess the efficacy and safety of Auvelity for treating AD agitation. Axsome plans to complete patient enrollment by the first half of 2024.
Axsome’s key pipeline candidates, including AXS-07, AXS-12 and AXS-14, target multiple central nervous system indications.
The lead candidate, AXS-07, is being developed for the acute treatment of migraine. In April 2022, Axsome received a complete response letter (CRL) for an NDA seeking approval for AXS-07 for the acute treatment of migraine.
Axsome intends to resubmit its NDA by the second half of 2023. The FDA has not requested any additional safety or efficacy data for the candidate in light of the NDA resubmission.
AXS-12 is being developed to treat narcolepsy — a sleep disorder characterized by excessive sleepiness. AXSM is enrolling patients in the phase III SYMPHONY study. Top-line data from this study is expected in the second quarter of 2023.
The company is also planning to submit an NDA by 2023-end to seek approval for AXS-14 to treat fibromyalgia.
A couple of better-ranked stocks for investors interested in the same sector are Ocuphire Pharma (OCUP - Free Report) and Allogene Therapeutics (ALLO - Free Report) . Ocuphire Pharma sports a Zacks Rank #1 (Strong Buy) and Allogene Therapeutics carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024 in the past 60 days.
The company’s shares have surged 64.6% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark once, the average surprise being 23.85%.
Loss per share estimates for Allogene have narrowed from $2.56 to $2.32 for 2023 and from $2.53 to $2.22 for 2024 in the past 60 days. Shares of ALLO have gained 0.5% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark once, the average surprise being 5.08%.
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Axsome (AXSM) Q1 Earnings Beat Estimates, Auvelity Volume Rises
Axsome Therapeutics, Inc. (AXSM - Free Report) incurred an adjusted loss 22 cents per share in the first quarter of 2023, narrower than the Zacks Consensus Estimate and our model estimate of a loss of $1.13 and $1.15, respectively. AXSM had reported a loss of $1.03 per share in the year-ago period.
The company’s $94.6 million revenues beat the Zacks Consensus Estimate and our model estimate of $27 million and $25.2 million, respectively. Axsome did not generate any revenue in the year-ago quarter due to the absence of a marketed product.
Revenues mainly benefitted from Sunosi ex-U.S. license agreement upfront payment received in the quarter.
Quarter in Detail
Net product revenues were $28.6 million in the quarter. Total revenues consist of product revenues from Sunosi (sleep drug), Auvelity (major depressive disorder drug), licensing and royalty revenues.
Auvelity recorded its first full-quarter sales of $15.7 million, up 302% from the previous quarter. There were no net sales in the comparable period. Auvelity is Axsome’s first drug approved by the FDA in August 2021 and launched in October 2022.
Sunosi net product sales were $12.9 million for the first quarter of 2023. There were no net sales in the comparable period for Sunosi. Total prescriptions for Sunosi increased 4% from the previous quarter.
Axsome acquired the U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals (JAZZ - Free Report) in May 2022. Axsome began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. Jazz received approval for Sunosi as a treatment for narcolepsy in 2019. JAZZ is entitled to receive high-single-digit royalty on U.S. net sales of Sunosi.
Axsome’s shares were up 5.5% on May 8, probably as Auvelity sales beat investor expectations. Shares of Axsome have gained 0.8% in the year-to-date period against the industry’s 5.5% decline.
Image Source: Zacks Investment Research
Licensing revenues were $65.7 million in the first quarter, representing an upfront payment from Pharmanovia for Sunosi commercialization rights in Europe, and other Middle East and North African countries.
Royalty revenues were $0.3 million for the quarter, reflecting Sunosi sales in the out-licensed territories.
Research and development expenses were $17.8 million in the quarter, up 41% from the year-ago period. The increase was due to higher costs associated with clinical studies and post-marketing commitments for Sunosi and Auvelity.
Selling, general and administrative expenses were $74.2 million, up 289% year over year. The significant increase was due to higher commercial activities for Sunosi and Auvelity, which included sales force onboarding and marketing spending.
As of Mar 31, 2023, Axsome had cash and cash equivalents worth $246.5 million compared with $200.8 million as of Dec 31, 2022.
2023 Guidance
Management believes that its cash balance of 246.5 million (as of March 2023 end) and its $350-million term-loan facility will be enough to fund future operations into cash flow positivity.
Pipeline Updates
Several label expansion studies on Auvelity are underway for the treatment of other CNS disorders. Axsome is evaluating Auvelityin a phase III study, ACCORD, for treating agitation associated with Alzheimer’s Disease (AD). Axsome plans to start a pivotal phase II/III study evaluation of Auvelity for smoking cessation by the fourth quarter of 2023.
The company is also conducting the ADVANCE-2 study, a parallel group trial, to assess the efficacy and safety of Auvelity for treating AD agitation. Axsome plans to complete patient enrollment by the first half of 2024.
Axsome’s key pipeline candidates, including AXS-07, AXS-12 and AXS-14, target multiple central nervous system indications.
The lead candidate, AXS-07, is being developed for the acute treatment of migraine. In April 2022, Axsome received a complete response letter (CRL) for an NDA seeking approval for AXS-07 for the acute treatment of migraine.
Axsome intends to resubmit its NDA by the second half of 2023. The FDA has not requested any additional safety or efficacy data for the candidate in light of the NDA resubmission.
AXS-12 is being developed to treat narcolepsy — a sleep disorder characterized by excessive sleepiness. AXSM is enrolling patients in the phase III SYMPHONY study. Top-line data from this study is expected in the second quarter of 2023.
The company is also planning to submit an NDA by 2023-end to seek approval for AXS-14 to treat fibromyalgia.
Axsome Therapeutics, Inc. Price and Consensus
Axsome Therapeutics, Inc. price-consensus-chart | Axsome Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Axsome has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks for investors interested in the same sector are Ocuphire Pharma (OCUP - Free Report) and Allogene Therapeutics (ALLO - Free Report) . Ocuphire Pharma sports a Zacks Rank #1 (Strong Buy) and Allogene Therapeutics carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024 in the past 60 days.
The company’s shares have surged 64.6% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark once, the average surprise being 23.85%.
Loss per share estimates for Allogene have narrowed from $2.56 to $2.32 for 2023 and from $2.53 to $2.22 for 2024 in the past 60 days. Shares of ALLO have gained 0.5% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark once, the average surprise being 5.08%.