Axsome Therapeutics (NASDAQ:AXSM), Inc. AXSM incurred a loss of 78 cents per share in the fourth quarter of 2020, wider than the Zacks Consensus Estimate of a loss of 73 cents per share and also the year-ago quarter’s loss of 71 cents.
Axsome currently does not have any approved product in its portfolio. As a result, the company is yet to generate revenues from the same.
Quarter in Detail
Research and development (R&D) expenses were $17.4 million in the quarter, down 9.3% from the year-ago period owing to completion of several studies on the pipeline candidates.
General and administrative (G&A) expenses were $10.4 million, up 100% year over year due to increased stock compensation expenses and personnel costs.
As of Dec 31 2020, Axsome had cash worth $ $183.9 million compared with $202.4 million as of Sep 30, 2020. Management believes that its cash balance as of December-end along with $225 million worth term-loan facility will be enough to fund its anticipated operations for at least through 2024.
Full-Year Results
For 2020, the company reported loss of $2.77 per share compared with the year-ago loss of $2.01 per share.
Pipeline Updates
Axsome’s pipeline candidates like AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14 are currently being developed for multiple central nervous system indications.
AXS-05, one of Axsome’s lead candidates, is being developed for treating major depressive disorder (“MDD”), treatment-resistant depression, smoking cessation and agitation associated with Alzheimer's disease (“AD”).
Along with the fourth-quarter earnings release, Axsome announced that it has submitted a new drug application (“NDA”) to the FDA for AXS-05 for the treatment of MDD. Investors might have cheered this news as shares of Axsome were up 2.7% following the above announcement on Monday. A potential approval for AXS-05 will be a huge boost for the company.
Axosme’s stock has declined 15% so far this year against the industry’s increase of 3.2%.
Notably, in December 2020, Axsome initiated the double-blind, placebo-controlled, randomized withdrawal phase III ACCORD study to evaluate the safety and efficacy of AXS-05 for treating agitation associated with AD. AXS-05 is already being evaluated in the pivotal phase II/III ADVANCE-1 study for AD agitation.
Meanwhile, Axsome’s another lead candidate, AXS-07, is being developed for the acute treatment of migraine. The NDA for AXS-07 for the acute treatment of migraine is expected to be filed early in the second quarter of 2021.
In December 2020, the company announced positive data from the long-term phase III MOVEMENT study evaluating AXS-07 for the acute treatment of migraine. Data from the study showed that treatment with AXS-07 led to rapidly, substantially and durably relieved migraine pain and associated symptoms in the patient population.
This apart, Axsome’s AXS-12 is being developed to treat narcolepsy, a sleep disorder characterized by excessive sleepiness. A placebo-controlled, parallel-group phase III study AXS-12 for the given indication is expected to begin in the second quarter of 2021.
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Lexicon Pharmaceuticals (NASDAQ:LXRX), Inc. LXRX, Repligen (NASDAQ:RGEN) Corporation RGEN and Nabriva (NASDAQ:NBRV)Therapeutics AG NBRV, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Lexicon’s loss per share estimates have narrowed 74.2% for 2021 over the past 60 days. The stock has skyrocketed 122.2% year to date.
Repligen’s earnings estimates have been revised 10.8% upward for 2021 over the past 60 days. The stock has rallied 15.8% year to date.
Nabriva’s loss per share estimates have narrowed 8.9% for 2021 over the past 60 days.
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