There's been a lot of focus on clinical stage biotech companies and the coronavirus vaccine race over the past few months. But President Donald Trump's recent COVID-19 diagnosis has thrown one particular biotech into the spotlight: Regeneron Pharmaceuticals (REGN 0.46%). Trump was administered Regeneron's investigational antibody cocktail and called it "a cure." Since the cocktail hasn't yet been approved for public use by the U.S. Food and Drug Administration (FDA), doctors were only able to offer it to Trump after his doctors made a "compassionate use" request.
Now, Regeneron is seeking an emergency use authorization (EUA) for the cocktail, known as REGN-COV2. In a statement on Twitter, Trump said that he would do everything possible to get the treatment to other COVID-19 patients as soon as possible. The president also said that the federal government would make it free to Americans and take care of distribution. With Trump championing Regeneron and the world eager for new treatment options, it's easy to feel optimistic about the company's prospects. But is Regeneron really heading toward victory? And should it be your next coronavirus buy? Let's find out.
Image source: Getty Images.
Trump's support
First, it's important to say this: The FDA has repeatedly said that it will not authorize or approve a treatment unless it's safe and effective. So, Trump's support alone won't lead to an EUA or regulatory approval. The FDA will consider REGN-COV2 patient data -- not the president's statements -- as it makes a decision on REGN-COV2. Nonetheless, Trump's words have brought Regeneron plenty of attention in the news and social media.
Here's a little background on the company's investigational antibody cocktail. Regeneron has enrolled more than 2,000 volunteers in its REGN-COV2 development program. The program includes testing the cocktail in hospitalized and non-hospitalized patients, and using REGN-COV2 in coronavirus prevention. If the treatment candidate proves safe and effective in all three groups, Regeneron could sell the product as a preventive therapy and treatment therapy for COVID-19. This means that Regeneron could capitalize off of not one, but two, massive addressable markets.
Regeneron's antibody cocktail is a blend of two monoclonal antibodies that work by signaling foreign invaders within the body and stimulating the immune system. Regeneron created the cocktail after screening thousands of antibodies from recovered coronavirus patients and from mice with human-like immune systems (thanks to genetic engineering).
So now the question is: What do we know about REGN-COV2's performance? Most recently, data from the first part of a phase 1/2/3 trial in non-hospitalized COVID-19 patients showed a reduction of viral load and improvement in symptoms.
Reducing "viral load"
The antibody cocktail was particularly beneficial in patients who hadn't already built up their own immune responses to COVID-19. In these patients, antiviral antibodies were largely absent: They had higher viral levels and cleared virus more slowly than those coronavirus patients who had produced antiviral antibodies. REGN-COV2 reduced these patients' viral load within seven days and reduced symptoms in six to eight days.
Regeneron's product candidate is being studied in three other trials: a phase 2/3 study in hospitalized patients, a phase 3 trial in U.K. hospitalized patients, and a phase 3 trial for the prevention of COVID-19 among those in close contact with a patient. Regeneron continues to recruit for all four studies.
It's impossible to say whether the FDA will offer Regeneron an EUA for the investigational antibody cocktail. There are reasons to be optimistic, however. First of all, the FDA is open to granting EUAs when merited. The agency has given others, including one to Gilead Sciences' (GILD 0.69%) remdesivir (Veklury). And second, trial results so far have been encouraging. Regeneron's capacity to bring a product to market is also a bright spot. The company says that it has doses ready for 50,000 patients and will have doses for about 300,000 patients in a few months. Looking further into the future, Regeneron should remain in a solid distribution position. The company recently partnered with Roche (RHHBY -1.51%) to increase capacity by more than three and a half times.
Cause for optimism
But here's why I'm really optimistic about Regeneron as your next coronavirus buy: The company doesn't depend on its coronavirus program for revenue. Regeneron has six products on the market, including blockbuster drug Eylea, a treatment for age-related macular degeneration. Annual revenue has been climbing steadily for more than a decade, up almost 1,600% from 2010 levels.
Regardless of the REGN-COV2 trial outcomes, Regeneron is likely to deliver revenue growth. Considering that growth, shares are reasonably priced. They currently trade at 23 times trailing-12-month earnings -- down from more than 32 times earnings a few months ago.
With dreams of an EUA and the reality of strong revenue growth in any case, now looks like a good time to buy this biotech stock.
