Axsome Therapeutics, 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, Inc.


LXRX

,

Repligen Corporation


RGEN

and

Nabriva


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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