Following the biotech reporting its earnings on Feb. 28, JMP Securities' analyst Jonathan Wolleben reiterated his opinion on Feb. 29 that Madrigal Pharmaceuticals (MDGL +2.07%) stock (priced at $247 a share) will rise by around 40% over the next 12 to 18 months to reach a price target of $347. The catalyst to watch closely will be how the company's flagship therapy program called resmetirom fares when it goes before the Food and Drug Administration (FDA) for final approval consideration on March 14.
Resmetirom is intended to treat the liver disease nonalcoholic steatohepatitis (NASH), also known as metabolic-associated steatohepatitis (MASH). If it gets approved, it'll be the first medicine for the condition, and also Madrigal's first product to reach the market.
NASDAQ: MDGL
Key Data Points
The upside could be huge, but it isn't guaranteed
Management thinks that its candidate could treat as many as 315,000 people in the U.S. at launch, with a total addressable patient population of 1.5 million who may be accessible further down the road. With its opportunity to be the first to penetrate such a large market, it's no surprise that Wolleben is so bullish. On average, Wall Street analysts forecast that the biotech's top line will be in the ballpark of $124 million this year, with revenue of $533 million in the following year.
And those who buy shares today could indeed reap the rewards if resmetirom is commercialized.
However, investors should take care to remember that MASH has traditionally been a difficult target for drug developers. Many late-stage trials have failed unceremoniously, and the FDA has somewhat unexpectedly given other companies the thumbs-down when their candidate was up for approval, even after they had an opportunity to address regulators' concerns. In other words, do not count your chickens before they hatch with this stock.
Nonetheless, if you can tolerate the uncertainty and don't balk at the idea of your investment taking a haircut, the company is worth investing in due to its potential first-mover advantage. Just be sure the remainder of your portfolio is diversified to better absorb any potential hit.
