Axsome Therapeutics (AXSM +1.06%) started out last year as a small up-and-coming biotech company. It finished the year with a more than 100% gain, beating the bear market and crushing the S&P 500. How did this happen?
Axsome launched its first two products, sleep disorders drug Sunosi and antidepressant Auvelity. And investors started to bet on the company's growth story.
This year, Axsome's ascent hasn't been as dramatic -- at least not so far. The stock has climbed less than 5%, but the company's days of beating the S&P 500 may not be over. In fact, Axsome may just be getting started.
The biotech recently shared its plans for the next few years and growth could skyrocket. Let's take a closer look.
A spectacular 2022
First, some background on Axsome's spectacular 2022. The company acquired Sunosi from Jazz Pharmaceuticals and launched the product in the spring. It then won regulatory approval for its own pipeline product Auvelity in the fall.
Auvelity has blockbuster potential -- even in the crowded antidepressant market. The drug stands out from many rivals because it's fast acting, with significant improvement seen in just a week.
Initial trends for both drugs look promising. In the most recent quarter, Sunosi prescriptions climbed 13%. As for Auvelity, the company reported 31,000 prescriptions -- a nearly 300% sequential increase from the previous quarter.
Axsome also reported progress on a migraine candidate last year after an initial setback. The U.S. Food and Drug Administration (FDA) asked Axsome for more information regarding chemistry, manufacturing, and controls (CMC) before considering the candidate for review.
After discussions with the FDA, Axsome said it addressed the issues and would resubmit the candidate later this year. All of this is positive. CMC issues are much easier to resolve than problems with safety or efficacy. And Axsome is on track for yet another potential launch in the near future.
Finally, last year, Axsome reported its candidate for Alzheimer's disease agitation met primary endpoints in a phase 3 trial. This is an area of great need. Agitation is seen in about 70% of Alzheimer's patients and often leads to faster cognitive decline.
Today, only one drug exists to treat Alzheimer's disease agitation -- the recently approved Rexulti from Otsuka Pharmaceutical Company and Lundbeck. Axsome's third phase 3 trial is ongoing and should be complete in the first half of next year.
NASDAQ: AXSM
Key Data Points
Six products by 2025
Considering all of this, it's no surprise Axsome shares climbed in 2022. But here's why they have what it takes to beat the market again. Axsome says it expects to have a total of six products on the market by 2025. This includes the currently available drugs, as well as treatments for narcolepsy, migraine, fibromyalgia, and Alzheimer's disease agitation.
Very soon, Axsome could become a multiproduct company with huge growth potential. The company predicts its portfolio -- including today's launched products plus the other six in the pipeline -- may generate as much as $11.5 billion in U.S. peak sales. By comparison, big biotech Biogen, a $43 billion company, reported about $10 billion in revenue last year. Today, Axsome's market value totals about $3.5 billion.
This doesn't mean Axsome will reach Biogen's size overnight. But it does suggest the company could be on its way to becoming a significant player.
Axsome's first launches could be among its biggest products. The company predicts peak U.S. sales of as much as $3 billion for Auvelity and $500 million for Sunosi.
In more good news, the company says its cash level of $247 million, along with capital from a $350 million loan facility, are enough to keep the company running until it becomes cash-flow positive.
All of this means Axsome has what it takes to crush the market again. Of course, it's impossible to predict if this will happen right away this year -- or sometime down the road.
But thanks to a solid pipeline and a plan to launch multiple products and reach billion-dollar revenue, Axsome could climb significantly from here. And that's great news for investors who buy the stock now -- or already have invested in this top growth story.
