Concerns about higher inflation and economic growth have weighed on investors' minds this year. But Axsome Therapeutics (AXSM -1.90%) has been defying the bear market. The biotech company's shares have climbed nearly 170% over the past three months.
The excitement stems from some pretty good news. Axsome won regulatory approval of its treatment for major depressive disorder (MDD). And the company has started generating revenue from a recently acquired sleep-disorder drug. All of this sounds promising. But after the company's recent gains, is it too late to get in on the story? Let's find out.
Five pipeline candidates
Axsome is a specialist in neuroscience. And the company's pipeline includes five candidates for various disorders -- from fibromyalgia to migraine. Most recently, the U.S. Food and Drug Administration (FDA) approved Auvelity for adults suffering from MDD.
The antidepressant market is crowded. But there's something that sets Auvelity apart. Auvelity results in significant improvements after just one week of use. Most antidepressants only result in signs of improvement after two to three weeks. This rapid action looks as if it may lead Auvelity right into blockbuster territory. The drug will reach $1.3 billion in sales by 2029, according to a GlobalData forecast.
Axsome plans to make Auvelity available in the fourth quarter of this year. This will be the company's second commercialized product. It acquired its first, Sunosi, from Jazz Pharmaceuticals earlier this year. Sunosi treats excessive daytime sleepiness in people with narcolepsy or obstructive sleep apnea.
Axsome already brought in $8.8 million from U.S. sales of Sunosi in a little over six weeks. The drug's sales soared 104% last year to $57.9 million when it was part of Jazz's portfolio.
With two new products, Axsome is heading into an exciting phase of its business: the phase of product revenue growth. So next year, once this revenue has had a chance to get going, could represent a clear turning point for Axsome.
Another plus is the stage of the company's pipeline candidates. They're all in phase 2 or 3. That means there's potential for other products to join the commercial portfolio in the near future.
For example, Axsome's fibromyalgia candidate has met primary endpoints in a phase 3 trial. The company plans to apply for approval next year. And Axsome expects to report phase 3 results from a trial of its narcolepsy candidate in the first half of 2023.
Of course, the ride hasn't been without bumps. The FDA didn't approve Axsome's migraine candidate in a recent review. But Axsome is in discussions with the agency to address concerns and plans to submit another request.
Is it a buy?
Now let's get back to whether Axsome is still is a buy after recent share price gains. Axsome shares actually traded higher than today's levels back in 2020. At that point, we had much less visibility about potential products than we do today. And the company wasn't generating product revenue. Wall Street predicts Axsome shares will climb 63% from today's level, according to the average 12-month forecast.
Of course, after soaring in a short period of time, Axsome shares may not take off overnight. But at today's level, Axsome represents a good buy for long-term investors.
The company is just at the beginning of its revenue story. And one of its new products looks like blockbuster material. That means there is reason for the shares to gain over time. So it's not too late to get in on this biotech player. This may be just the start of Axsome's successes -- and your rewards as an investor in the company.