Copying someone else's actions isn't always bad, at least when it comes to investing. We have a lot to gain by studying the moves of super-investors, and in some cases, following along. So who should we be looking at these days? Cathie Wood, founder, CEO, and chief investment officer (CIO) of ARK Invest. Wood's exchange-traded funds (ETFs), which include a Genomic Revolution ETF, Fintech Innovation ETF, and a general ARK Innovation ETF (among others), have handily outperformed the S&P 500 over the past year. The funds specialize in innovation in various areas -- from genomics to next-generation internet technologies.
Earlier this month, the ARK Genomic Revolution fund purchased more than 100,000 shares of Regeneron Pharmaceuticals (REGN -0.27%). Regeneron, maker of an antibody cocktail to treat COVID-19, is the fund's fourth-biggest holding. Let's take a closer look at Regeneron to see if we should follow superstar investor Wood into this biotech stock.
A treatment for COVID-19
In November, the U.S. Food and Drug Administration granted Regeneron's antibody cocktail Emergency Use Authorization (EUA) to treat mild to moderate COVID-19 in patients at risk of severe disease or hospitalization. The FDA earlier offered rival Eli Lilly (LLY -0.41%) an EUA for another antibody treatment, for the same patient group.
Antibody treatments help the body construct a defense system against the virus. When you have a virus, your body builds up antibodies to fight it. With antibody treatments, you're directly administered antibodies that will fight a particular virus.
It may seem surprising, but both Regeneron and Lilly have faced the challenge of getting patients to use their antibody treatments. In many locations, only about 5% of the available supply was in use in December, according to Bloomberg.
Here's the problem. Antibody treatments require infusion in a healthcare setting. Yet the Regeneron and Lilly EUAs are for non-hospitalized patients. In some cases, hospitals have resources dedicated to treating the sickest patients and they don't have enough room or staff to provide antibody infusions. In other cases, potential infusion candidates don't want to spend an hour or so at a hospital -- and risk contact with others who might transmit the virus.
The good news is, efforts to boost use of these therapies are underway. The government has set up dedicated infusion centers, and The National Infusion Center Association has launched an "infusion locator" for potential patients. The hope now is this will encourage more patients to give antibody cocktails a try.
Data, so far, has been on Regeneron's side. In a recent report, the cocktail showed positive results in a phase 3 coronavirus prevention trial. It was administered by subcutaneous injection as a sort of vaccine for those at high risk -- for instance someone whose housemate has COVID-19. The study showed 100% prevention of symptomatic infection. Any infections that did arise were asymptomatic cases. Regeneron expects to report confirmatory results in the second quarter.
The company continues to study the cocktail in a phase 3 trial for non-hospitalized patients and two late-stage studies in hospitalized patients, too. Regeneron expects to apply to the FDA for full approval of this treatment and prevention candidate later this year.
And the best news yet? The antibody cocktail has also shown to be effective against the U.K. and South Africa coronavirus variants.
What about revenue?
The antibody cocktail alone is a billion-dollar opportunity. The U.S. government in January agreed to buy up to 1.25 million additional doses of the treatment. That represents as much as $2.6 billion in revenue. The U.S. had already purchased 300,000 doses last year, and orders from Europe may roll in later in the year. The European Medicines Agency has begun a rolling review of the cocktail.
The picture looks bright for Regeneron in the coronavirus space -- if patient use picks up. And there's more to the company than coronavirus treatments. Regeneron has eight commercialized drugs, including blockbusters Eylea and Dupixent, which brought in more than $7.9 billion and $4 billion, respectively, in revenue last year. Eylea treats eye disorders such as neovascular (wet) age-related macular degeneration, and Dupixent treats atopic dermatitis and asthma.
Considering the antibody cocktail's potential and Regeneron's portfolio, I expect more revenue growth ahead. And to me, that means share gains in the long term. Regeneron shares are trading at their cheapest in relation to earnings in about a year and a half.
The stock is trading about 9% below Wall Street's lowest 12-month share price forecast, and its performance hasn't been brilliant this year -- down about 4.5%. So it may take awhile for the tide to turn. Investors are focused on coronavirus vaccines right now, but once the initial vaccine rollout is over, they may turn their attention to companies working on treatments.
At that point and beyond, Regeneron could benefit. So yes, investors should follow Wood into this biotech stock. Patience today will likely lead to rewards well into the future.