Lately, one of America's leading pharmaceutical companies can't catch a break from Wall Street. Shares of Vertex Pharmaceuticals(NASDAQ: VRTX) are down about 9% from a peak the stock set in November, despite some highly positive news.
The U.S. Food and Drug Administration (FDA) approved suzetrigine under the brand name Journavx on Jan. 30, 2025. Journavx is a first-in-class non-opioid painkiller that acts on sodium channels in the peripheral nervous system.
Each year, around 80 million Americans are prescribed a medicine for moderate to severe pain. Journavx is the first new type of painkiller approved in more than 20 years. It prevents pain signals from reaching the brain.
A lack of activity in the brain makes Journavx a non-addictive solution for all types of moderate to severe pain. Its non-addictive nature should encourage physicians to stop prescribing short courses of highly addictive opioids and prescribe Journavx in their place.
Unfortunately, the stock market barely noticed Vertex's achievement. A few hours into the trading session following the FDA's announcement, the stock was trading about 6% higher.
Mixed expectations for Journavx
In its favor, the FDA granted Journavx broad approval to address moderate to severe acute pain in adults, regardless of its cause. Its lack of addictive properties is a huge selling point for physicians who don't want to start patients with acute pain on an opioid addiction journey.
While Journavx has some important factors that could lead to a successful commercial launch, it's only about as powerful as Vicodin tablets. In a clinical trial with patients who received a tummy tuck procedure, Journavx reduced pain intensity slightly better than Vicodin, but the difference wasn't large enough to be considered statistically significant.
In a second pivotal study with patients who had bunions removed, Journavx significantly reduced pain compared to a placebo. Unfortunately, its performance against Vicodin wasn't as impressive. During the study, 12% of patients who received Journavx discontinued due to lack of efficacy, compared to just 8% of patients randomized to receive Vicodin.
While some analysts predict more than $5 billion in annual sales for Journavx, this could be wishful thinking. A relatively high price of about $30 per day, and approval to treat acute versus chronic pain, could limit annual sales to around $1.5 billion by 2030.
Adding around $1.5 billion in annual sales by 2030 would be a step in the right direction for Vertex Pharmaceuticals but this wouldn't be a transformative contribution. In November, the company reported third-quarter product sales that rose 12% year over year to an annualized $11.1 billion.
More than just Journavx
Journavx isn't the only recently approved treatment that Vertex has for sale. A little over a year ago, the FDA approved Casgevy, a cellular therapy, for the treatment of sickle cell disease and beta-thalassemia.
Casgevy is a one-and-done treatment that Vertex is marketing and developing in partnership with CRISPR Therapeutics(NASDAQ: CRSP). As a treatment administered only once, it carries an enormous $2.2 million list price.
Vertex and CRISPR Therapeutics haven't started recording significant sales of Casgevy yet, but it could start contributing to their top lines soon. At the end of 2024, more than 50 authorized treatment centers in the U.S. had initiated the treatment process with over 50 patients.
In December, the FDA approved Alyftrek, a new once-daily pill for patients with cystic fibrosis caused by at least one of 303 possible mutations in their CFTR genes. Alyftrek's precursor, Trikafta, earned approval to treat cystic fibrosis patients with 94 new mutations. Approval to address those new mutations should translate to roughly 300 new U.S. patients.
A buy now?
Investors will want to keep an eye on incoming sales of Casgevy and results from an ongoing phase 3 study with Journavx and patients with diabetic nerve pain. Approval to treat this chronic condition that affects roughly one-third of folks with diabetes could push the painkiller's peak sales estimates much higher.
At recent prices, you can pick up shares of Vertex Pharmaceuticals for about 24.7 times forward-looking earnings expectations. That's a reasonable valuation for this drugmaker's cystic fibrosis portfolio on its own. Adding some shares now to hold over the long run looks like a smart move.
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Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends CRISPR Therapeutics and Vertex Pharmaceuticals. The Motley Fool has a disclosure policy.
